RRMM에서 포말리도마이드 및 덱사메타손과 병용한 SC 대 IV 이사툭시맙 (IRAKLIA)
2026년 8월 10일 업데이트: Sanofi
재발성 및/또는 불응성 다발성 골수종(RRMM) 성인 환자에서 포말리도마이드 및 덱사메타손과 병용 이사툭시맙의 피하 투여와 정맥 투여를 평가하는 무작위 3상 공개 라벨 연구
이것은 이전에 최소 1회 이상 치료를 받은 RRMM 환자(연구 참여자)를 대상으로 포말리도마이드 및 덱사메타손(Pd)과 함께 isatuximab의 피하(SC) 투여와 정맥내(IV) 투여를 평가하는 무작위배정, 다기관, 3상 공개 라벨 연구입니다. 레날리도마이드 및 프로테아좀 억제제(PI)를 포함한 치료법. 적격 참가자는 1:1로 2개의 연구 부문 중 하나로 무작위 배정됩니다.
팔 SC: 이사툭시맙 SC + Pd
IV군: 이사툭시맙 IV + Pd
참가자는 질병 진행, 용인할 수 없는 부작용(AE), 참가자의 치료 중단 요청 또는 기타 이유 중 먼저 발생하는 시점까지 치료를 계속할 수 있습니다.
연구 개요
상태
모집하지 않고 적극적으로
상세 설명
2개의 연구 부문은 질병 진행, 용인할 수 없는 부작용(AE), 참가자의 치료 중단 요청 또는 기타 이유 중 먼저 발생하는 시점까지 4주 주기로 치료됩니다.
연구 유형
중재적
등록 (실제)
531
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Athens, 그리스, 106 76
- Investigational Site Number : 3000002
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Athens, 그리스, 115 28
- Investigational Site Number : 3000001
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Pátrai, 그리스, 265 04
- Investigational Site Number : 3000003
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Thessaloniki, 그리스, 570 10
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Oslo, 노르웨이, 0450
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Ålesund, 노르웨이, 6017
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Kaohsiung City, 대만, 833
- Investigational Site Number : 1580001
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Tainan, 대만, 704
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Taipei, 대만, 100
- Investigational Site Number : 1580002
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Dresden, 독일, 01307
- Investigational Site Number : 2760005
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Heidelberg, 독일, 69120
- Investigational Site Number : 2760003
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Lübeck, 독일, 23562
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Nuremberg, 독일, 90419
- Investigational Site Number : 2760007
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Colorado
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Aurora, Colorado, 미국, 80012
- Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021
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Florida
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Jacksonville, Florida, 미국, 32224
- Mayo Clinic in Florida- Site Number : 8400008
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Plantation, Florida, 미국, 33322
- Boca Raton Clinical Research Associates- Site Number : 8400030
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Mississippi
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Hattiesburg, Mississippi, 미국, 39401
- Hattiesburg Clinic- Site Number : 8400006
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New Jersey
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Morristown, New Jersey, 미국, 07962
- Atlantic Health System- Site Number : 8400005
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New York
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Albany, New York, 미국, 12206
- New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017
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North Carolina
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Charlotte, North Carolina, 미국, 28207
- Novant Health Neurology & Sleep- Site Number : 8400014
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Ohio
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Canton, Ohio, 미국, 44718
- Gabrail Cancer Center- Site Number : 8400027
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Fairfield, Ohio, 미국, 45014
- Oncology Hematology Care - Fairfield- Site Number : 8400016
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South Carolina
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Spartanburg, South Carolina, 미국, 29303
- Spartanburg Regional Medical Center- Site Number : 8400002
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Texas
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Dallas, Texas, 미국, 75390
- University of Texas - Southwestern Medical Center- Site Number : 8400024
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San Antonio, Texas, 미국, 78240
- Texas Oncology - San Antonio Medical Center - Research Drive- Site Number : 8400020
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Utah
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Salt Lake City, Utah, 미국, 84108
- Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011
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Rio de Janeiro, 브라질, 22775-001
- Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004
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São Paulo, 브라질, 04537-080
- Clinica São Germano- Site Number : 0760001
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Ceará
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Fortaleza, Ceará, 브라질, 60115-280
- Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006
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Pernambuco
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Recife, Pernambuco, 브라질, 51020-280
- MultiHemo - Recife - Rua Padre Carapuceiro- Site Number : 0760007
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, 브라질, 90880-480
- Hospital Mae de Deus- Site Number : 0760003
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Rio de Janeiro
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Niterói, Rio de Janeiro, 브라질, 24020-096
- CHN - Complexo Hospitalar de Niterói- Site Number : 0760008
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Borås, 스웨덴, 501 82
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Huddinge, 스웨덴, 141 57
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Madrid, 스페인, 28034
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Salamanca, 스페인, 37007
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Almería
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Murcia, Almería, 스페인, 30120
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Barcelona [Barcelona]
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Badalona, Barcelona [Barcelona], 스페인, 08916
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Cantabria
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Santander, Cantabria, 스페인, 39008
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Navarre
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Pamplona, Navarre, 스페인, 31008
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Buenos Aires, 아르헨티나, 1181
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Buenos Aires, 아르헨티나, 1180
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Buenos Aires, 아르헨티나, 1280
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Buenos Aires, 아르헨티나, 1417
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Buenos Aires, 아르헨티나, 1426
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Buenos Aires, 아르헨티나, 1430
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Buenos Aires, 아르헨티나, 1431
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Córdoba, 아르헨티나, 5000
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Mendoza, 아르헨티나, 5501
- Investigational Site Number : 0320009
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Buenos Aires
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La Plata, Buenos Aires, 아르헨티나, 1900
- Investigational Site Number : 0320006
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Derbyshire
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Derby, Derbyshire, 영국, DE22 3NE
- Investigational Site Number : 8260003
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England
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Birmingham, England, 영국, B15 2TH
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Leicestershire
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Leicester, Leicestershire, 영국, LE1 5WW
- Investigational Site Number : 8260002
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London, City of
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London, London, City of, 영국, W12 0HS
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Norfolk
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Norwich, Norfolk, 영국, NR4 7UY
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Bologna, 이탈리아, 40138
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Brescia, 이탈리아, 25123
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Pavia, 이탈리아, 27100
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Ancona
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Torette, Ancona, 이탈리아, 60020
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Reggio Emilia
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Meldola, Reggio Emilia, 이탈리아, 47014
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Roma
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Rome, Roma, 이탈리아, 00168
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Kyoto, 일본, 603-8151
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Osaka, 일본, 530-8480
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Tokyo, 일본, 150-8935
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Yamagata, 일본, 990-9585
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Aichi-ken
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Nagoya, Aichi-ken, 일본, 467-8602
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Chiba
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Kamogawa, Chiba, 일본, 296-8602
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Ibaraki
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Higashiibaraki, Ibaraki, 일본, 311-3117
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Iwate
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Yahaba, Iwate, 일본, 028-3695
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Kanagawa
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Kamakura, Kanagawa, 일본, 247-8533
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Okayama-ken
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Okayama, Okayama-ken, 일본, 701-1192
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Beijing, 중국, 100191
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Beijing, 중국, 100034
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Changsha, 중국, 410013
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Guangzhou, 중국, 510060
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Hangzhou, 중국, 310003
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Nanchang, 중국, 330006
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Nanning, 중국, 530021
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Qingdao, 중국, 266011
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Shenyang, 중국, 110004
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Tianjin, 중국, 300020
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Tianjin, 중국, 300060
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Tianjin, 중국, 300052
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Wuhan, 중국, 430022
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Wuhan, 중국, 430030
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Zhengzhou, 중국, 450008
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Brno, 체코, 625 00
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Olomouc, 체코, 779 00
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Ostrava, 체코, 708 52
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Prague, 체코, 128 08
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La Araucanía
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Temuco, La Araucanía, 칠레, 4780000
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Reg Metropolitana de Santiago
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Santiago, Reg Metropolitana de Santiago, 칠레, 7580206
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Santiago, Reg Metropolitana de Santiago, 칠레, 6900941
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Santiago, Reg Metropolitana de Santiago, 칠레, 7620001
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Santiago, Reg Metropolitana de Santiago, 칠레, 8380455
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Valparaiso
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Viña del Mar, Valparaiso, 칠레, 2540364
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Ontario
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Toronto, Ontario, 캐나다, M5G 2M9
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Quebec
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Greenfield Park, Quebec, 캐나다, J4V 2H1
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Montreal, Quebec, 캐나다, H1T 2M4
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Ankara, 터키 (Türkiye), 06010
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Ankara, 터키 (Türkiye), 06200
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Istanbul, 터키 (Türkiye), 34093
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Istanbul, 터키 (Türkiye), 34098
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Istanbul, 터키 (Türkiye), 34214
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Istanbul, 터키 (Türkiye), 34381
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Izmir, 터키 (Türkiye), 35100
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, 폴란드, 31-501
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, 폴란드, 50-088
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, 폴란드, 20-081
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Nantes, 프랑스, 44093
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Paris, 프랑스, 75571
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Poitiers, 프랑스, 86021
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Saint-Priest-en-Jarez, 프랑스, 42270
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Toulouse, 프랑스, 31059
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Tours, 프랑스, 37032
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Budapest, 헝가리, 1097
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Budapest, 헝가리, 1085
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Kaposvár, 헝가리, 7400
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Pécs, 헝가리, 7623
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Szombathely, 헝가리, 9700
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Székesfehérvár, 헝가리, 8000
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New South Wales
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Liverpool, New South Wales, 호주, 2170
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Waratah, New South Wales, 호주, 2298
- Investigational Site Number : 0360004
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Wollongong, New South Wales, 호주, 2500
- Investigational Site Number : 0360003
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South Australia
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Adelaide, South Australia, 호주, 5000
- Investigational Site Number : 0360008
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Victoria
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Melbourne, Victoria, 호주, 3004
- Investigational Site Number : 0360006
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Melbourne, Victoria, 호주, 3065
- Investigational Site Number : 0360009
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Richmond, Victoria, 호주, 3121
- Investigational Site Number : 0360001
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 레날리도마이드 및 프로테아좀 억제제를 포함하여 이전에 최소 한 가지 요법을 받았고 측정 가능한 혈청 M-단백질(≥ 0.5g/dL) 및/또는 소변 M-단백질(≥ 200mg/24시간)을 가진 다발성 골수종 참가자 및/또는 혈청 유리 경쇄(FLC) 분석(관련 FLC 분석 ≥10mg/dL 및 비정상 혈청 FLC 비율(1.65))
제외 기준:
- 18세 미만 참가자, Eastern Cooperative Oncology Group 수행 상태가 2 이상인 참가자
- 원발성 불응성 다발성 골수종 참가자
- 9개월 미만의 휴약 기간으로 항-CD38에 불응하거나 항-CD38 mAb 제제에 내약성이 없는 참가자
- 포말리도마이드를 사용한 선행 요법
- 부적절한 생물학적 테스트를 받은 참가자.
- 중대한 심장 기능 장애
- 피부의 기저 세포 암종 또는 편평 세포 암종 및 원위치 악성종양의 완전 절제를 제외하고 무작위 배정 전 3년 이내에 다른 암에 대해 진단받았거나 치료를 받은 참가자, 치료 요법 후 저위험 전립선암
- 수반되는 형질 세포 백혈병
- 활성 원발성 아밀로이드-라이트(AL) 아밀로이드증
- 알려진 후천성 면역결핍 증후군(AIDS) 관련 질병 또는 항바이러스 치료가 필요한 알려진 인간 면역결핍 바이러스(HIV) 질병
- 활동성 A형 간염 감염을 알 수 있습니다. 현재 활동성 또는 만성 B형 간염(HBV) 또는 C형 간염(HCV) 감염. 항바이러스 요법으로 조절되는 만성 HBV 또는 HCV 질환이 있는 참가자는 허용됩니다.
- 가임기 여성 또는 매우 효과적인 피임 방법을 사용하는 데 동의하지 않는 가임기 여성이 있는 남성 참여자
위의 정보는 참가자의 임상 시험 참여와 관련된 모든 고려 사항을 포함하지 않습니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 이사툭시맙 정맥내(IV)
이사툭시맙 용량은 1주기(1일, 8일, 15일, 22일)와 후속 주기의 1일, 15일 동안 4주 동안 매주 IV 주입을 통해 투여됩니다.
각 주기는 28일입니다.
포말리도마이드 용량은 이사툭시맙 투여 전이나 투여 후 참가자에게 가장 편리한 시간에 각 주기의 1일부터 21일까지, 바람직하게는 매일 같은 시간에 경구 복용됩니다.
덱사메타손은 1일, 8일, 15일, 22일에 경구 복용됩니다(28일마다 반복).
참가자는 배경 치료 및/또는 구조 약물로 다른 치료를 받을 수 있습니다.
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제약 형태: 정제; 투여 경로: 경구
제약 형태: 경질 캡슐; 투여 경로: 경구
다른 이름들:
약제학적 형태: IV 주입용 농축 용액; 투여 경로: 정맥
다른 이름들:
의약품 형태: 지역 상용 제품에 따름; 투여 경로: 경구; 보조 의약품(AxMP), 즉 배경 치료; ATC 코드: H02AB02
의약품 형태: 지역 상용 제품에 따름; 투여 경로: 경구; AxMP, 즉 배경 처리; ATC 코드: R03DC03
의약품 형태: 지역 상용 제품에 따름; 투여 경로: 경구; AxMP, 즉 배경 처리; ATC 코드: N02BE01
의약품 형태: 지역 상용 제품에 따름; 투여 경로: 투약 전- 경구로; 주입 반응 관리 - IV(또는 경구 동등물); AxMP 즉, 배경 치료 및 구조 약물(주입 반응의 경우); ATC 코드: R06AA02
의약품 형태: 지역 상용 제품에 따름; 투여 경로: 전처치-IV로서; 주입 반응 관리용- IV(또는 경구 동등물); AxMP 즉, 배경 치료 및 구조 약물(주입 반응의 경우); ATC 코드: H02AB04
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실험적: Isatuximab Subcutaneous (SC)
Isatuximab dose will administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles.
Each cycle will be 28 days in duration.
Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day.
Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days).
Participants may receive other treatments as background treatment and/or rescue medication.
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약제학적 형태: 피하 투여용 용액; 투여 경로: 피하(SC)
다른 이름들:
제약 형태: 정제; 투여 경로: 경구
제약 형태: 경질 캡슐; 투여 경로: 경구
다른 이름들:
의약품 형태: 지역 상용 제품에 따름; 투여 경로: 경구; 보조 의약품(AxMP), 즉 배경 치료; ATC 코드: H02AB02
의약품 형태: 지역 상용 제품에 따름; 투여 경로: 경구; AxMP, 즉 배경 처리; ATC 코드: R03DC03
의약품 형태: 지역 상용 제품에 따름; 투여 경로: 경구; AxMP, 즉 배경 처리; ATC 코드: N02BE01
의약품 형태: 지역 상용 제품에 따름; 투여 경로: 투약 전- 경구로; 주입 반응 관리 - IV(또는 경구 동등물); AxMP 즉, 배경 치료 및 구조 약물(주입 반응의 경우); ATC 코드: R06AA02
의약품 형태: 지역 상용 제품에 따름; 투여 경로: 전처치-IV로서; 주입 반응 관리용- IV(또는 경구 동등물); AxMP 즉, 배경 치료 및 구조 약물(주입 반응의 경우); ATC 코드: H02AB04
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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전체 반응률 (ORR)
기간: 연구 약물 첫 투여 시점(1일차)부터 PCD(2024년 11월 6일)까지, 약 28개월
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독립 검토 위원회(IRC)가 2016년 국제 골수종 작업 그룹(IMWG) 기준을 사용한 객관적 반응율(ORR):완전 관해(CR),엄격한 완전 관해(sCR),매우 양호한 부분 관해(VGPR) 및 부분 관해(PR)를 보인 참가자의 비율.CR:혈청 및 요에서 면역고정법 음성,연조직 형질세포종(STP) 소실,골수(BM) 흡인 검사에서 형질세포 <5%,정상 유리 경쇄(FLC) 비율(0.26-1.65).sCR:CR
더하기 BM 생검에서 클론성 세포 없음.
VGPR:면역고정법으로 검출 가능한 혈청 및 요 M-단백(전기영동법 아님);혈청 M-단백 90% 이상 감소 및 요 M-단백 수치 <100mg/24시간(h);STP에서 기준선 대비 최대 직경 합(SPD) 90% 이상 감소;FLC만 해당:관련 및 비관련 FLC 수치 차이 90% 이상 감소.PR:혈청 M-단백 50% 이상 감소 및 24시간 요 M-단백 90% 이상 감소 또는 <200mg/24h.위 조건 외에도 기준선에 존재한 경우 STP의 SPD 크기 50% 이상 감소 필요.
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연구 약물 첫 투여 시점(1일차)부터 PCD(2024년 11월 6일)까지, 약 28개월
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이사툭시맙 정상상태 시 약물 투여 전 관찰 농도 (Ctrough)
기간: 사이클 6일차 1일 투여 전
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정상 상태에서의 Ctrough는 isatuximab 투여 용량의 사이클 6 일차 투여 전(사이클 6 일차 이전과 동등)에 수집된 관찰된 혈장 농도였습니다.
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사이클 6일차 1일 투여 전
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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4주차 이사투시맙 최저혈중농도 (CT4W)
기간: 사이클 2 1일차 투약 전(4주차)
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CT4W는 이사투시맵 투여 용량의 사이클 2 일 1일 투여 전(사이클 2 일 1일 이전과 동등)에 수집된 관찰된 혈장 농도였습니다.
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사이클 2 1일차 투약 전(4주차)
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'환자 경험 및 만족도 설문조사(PESQ-FU): 주사 방법에 대한 만족도'(항목-8)에서 사이클 5 일차 15에 '매우 만족함' 및 '만족함'으로 응답한 참가자 비율
기간: 사이클 5 일차 15
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PESQ-FU는 9개 문항으로 구성되어 있으며, 참가자의 주사 방법(불편함, 통증, 부작용, 시간 절약 및 만족도) 및 연구 약물(부작용, 복용 가치, 만족도 및 추천)에 대한 경험과 만족도를 후속 조사하기 위해 설계되었습니다.
이 설문지는 종양학 참가자들과의 질적 인터뷰를 바탕으로 수정되었습니다.
'주사 방법에 대한 만족도'에 대한 응답은 지정된 시간대에 '매우 만족함, 만족함, 만족스럽지도 불만족스럽지도 않음, 불만족함, 매우 불만족함'으로 기록되었습니다.
주기 5일 15일에 주사 방법(문항-8)에 대해 매우 만족함 및 만족함으로 응답한 참가자의 총 비율이 여기에 보고됩니다.
비율은 소수점 첫째 자리에서 반올림되었습니다.
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사이클 5 일차 15
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이사투시맙의 Ctrough
기간: 사이클 1 8일차, 15일차 및 22일차 투약 전, 사이클 2~5 1일차 및 15일차, 사이클 6, 7, 8, 9, 12, 15, 18, 21, 24 및 27 1일차 투약 전
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플라스마 샘플은 Ctrough 평가를 위해 지정된 시간대에 수집되었습니다.
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사이클 1 8일차, 15일차 및 22일차 투약 전, 사이클 2~5 1일차 및 15일차, 사이클 6, 7, 8, 9, 12, 15, 18, 21, 24 및 27 1일차 투약 전
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기준선에서 '환자 기대 설문지(PEQ-BL)'에 응답한 참가자 비율
기간: 기준선 (사이클 1 1일차)
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주사 방법에 따른 통증, 불편감 및 부작용에 대한 기대, 주사 방법이 시간을 절약할 것이라는 점, 연구 약물이 부작용을 초래할 수 있으며 복용할 가치가 있다는 점에 대해 기준선에서 매우 동의하거나 동의한다고 응답한 참가자의 비율이 보고되었습니다.
PEQ-BL은 7개 항목으로 구성되었습니다.
정맥 및/또는 피하 투여를 통해 약물을 투여받은 적이 있는 참가자의 비율도 보고되었습니다.
비율은 소수점 첫째 자리에서 반올림되었습니다.
기준값은 연구 약물 시작일 또는 그 이전에 수집된 마지막으로 결측값이 아닌 값으로 정의되었습니다.
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기준선 (사이클 1 1일차)
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건강 자원 활용도 및 생산성 설문지(HRUPQ): 기초 의료 서비스 활용도: 참가자가 지난 6개월 동안 진료를 받은 횟수
기간: 기준선 (사이클 1 일 1)
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연구 약물 투여 전 기준 시점의 의료 이용 현황은 HRUPQ를 통해 수집되었습니다.
참가자가 MM을 포함한 모든 건강 문제 또는 MM으로 인해 지난 6개월 동안 병원 외래 또는 응급실에서 치료를 받은 횟수와 MM을 포함한 모든 건강 문제 또는 MM으로 인해 간호사 또는 다른 의료 전문가로부터 가정 내 치료를 받은 횟수의 평균값이 제시됩니다.
기준값은 연구 약물 시작일 이전 또는 당일에 수집된 마지막으로 결측값이 아닌 값으로 정의되었습니다.
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기준선 (사이클 1 일 1)
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HRUPQ: 기초 의료 이용률: 참가자가 병원에 머문 과거 6개월 간의 입원 일수
기간: 기준선 (주기 1 일 1)
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연구 약물 투여 전 기준선에서의 의료 이용은 HRUPQ를 통해 수집되었습니다.
참가자가 MM을 포함한 모든 건강 문제 또는 MM으로 인해 지난 6개월 동안 병원에 입원한 평균 야간 수와 MM을 포함한 모든 건강 문제 또는 MM으로 인해 중환자실(ICU)에 입원한 평균 야간 수가 제시됩니다.
기준값은 연구 약물 시작 일자 또는 그 이전에 수집된 마지막 비결측값으로 정의되었습니다.
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기준선 (주기 1 일 1)
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HRUPQ: 기초 의료 이용률: 참가자가 지난 6개월 동안 의료 전문가(HCP)를 상담한 횟수
기간: 기준선 (사이클 1 1일차)
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연구 약물 투여 전 기준선에서의 의료 서비스 이용은 HRUPQ를 통해 수집되었습니다.
참가자가 지난 6개월 동안 상담(만나거나 이야기한)한 다음 의료 전문가의 평균 횟수: 다양한 질병을 치료하는 일반 의사 또는 1차 진료 임상의(PCC) - MM을 포함하거나 MM 관련 건강 문제 포함, 물리 치료사 또는 작업 치료사 - MM을 포함하거나 MM 관련 건강 문제 포함, 정신 건강 전문가(예: 정신과 의사, 심리학자, 정신과 간호사) - MM을 포함하거나 MM 관련 건강 문제 포함, 특정 의학적 질병 또는 문제를 전문으로 하는 의사 또는 임상의(전문의) - MM을 포함하거나 MM 관련 건강 문제 포함이 제시됩니다.
기준값은 연구 약물 시작일 또는 그 이전에 수집된 마지막 비결측값으로 정의되었습니다.
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기준선 (사이클 1 1일차)
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HRUPQ에 기반한 연구 기간 중 퇴직한 참가자 비율
기간: 연구 약물 첫 투여 시점(1일차)부터 PCD(2024년 11월 6일)까지, 약 28개월
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고용 상태는 HRUPQ를 통해 평가되었습니다.
연구 기간 중 한 번이라도 은퇴한 참가자의 비율이 보고됩니다.
백분율은 소수점 첫째 자리에서 반올림됩니다.
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연구 약물 첫 투여 시점(1일차)부터 PCD(2024년 11월 6일)까지, 약 28개월
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HRUPQ 기준 다발성 골수종으로 인해 조기 퇴직한 참가자 비율
기간: 연구용 약물 첫 투여 시점(1일차)부터 PCD(2024년 11월 06일)까지, 약 28개월
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고용 상태는 HRUPQ를 통해 평가되었습니다.
다발성 골수종(MM)으로 인해 조기 퇴직한 참가자의 비율이 보고되었습니다.
비율은 소수점 첫째 자리에서 반올림되었습니다.
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연구용 약물 첫 투여 시점(1일차)부터 PCD(2024년 11월 06일)까지, 약 28개월
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Very Good Partial Response or Better Rate
기간: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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VGPR or better rate by IRC using 2016 IMWG criteria: Percentage of participants with sCR, CR, and VGPR.
CR: negative immunofixation on serum and urine, disappearance of any STP, <5% plasma cells in BM aspirates & normal FLC ratio (0.26-1.65).
sCR: CR plus no clonal cells in BM biopsy.
VGPR: serum and urine M-protein detectable by immunofixation, not electrophoresis;>=90% reduction in serum M-protein plus urine M-protein level<100mg/24h;>=90% decrease in SPD compared to baseline in STP; FLC only:>=90% decrease in difference between involved and uninvolved FLC levels.
Percentages are rounded off to the tenth decimal place.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Percentage of Participants With Infusion Reactions
기간: From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
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Infusion reactions were graded using National Cancer Institute-Common Terminology Criteria for AE (NCI-CTCAE) version (v)5.0 criteria: Grade 1: mild transient reaction; infusion interruption not indicated; intervention not indicated.
Grade 2: moderate reaction; therapy or infusion interruption indicated but responds promptly to symptomatic treatment; prophylactic medications indicated for <=24 hours.
Grade 3/4: severe or life-threatening reaction (Grade 3: prolonged [not rapidly responsive to symptomatic medication and/or brief interruption of infusion]; recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae.
Grade 4: life-threatening consequences; urgent intervention indicated).
Percentage of participants who observed AE of infusion reactions were collected through the electronic case report form (eCRF) as assessed by investigators.
Percentages are rounded off to the tenth decimal place.
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From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
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Duration of Response (DOR)
기간: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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DOR: Time from the date of first response to the date of first occurrence of progressive disease (PD) determined by IRC or death from any cause, whichever occurred first.DOR was determined only for participants who achieved a response (PR or better).If PD/death not observed, participant was censored at date of last valid disease assessment performed prior to initiating further anti-myeloma treatment or analysis cut-off date, whichever occurred first.
As per IMWG criteria: PD: increase of >=25% from lowest confirmed value in any 1 of following: serum M-protein (absolute increase>=0.5 gram/deciliter[g/dL]),serum M-protein increase>=1g/dL if lowest M-component >=5g/dL, urine M-component (absolute increase >=200mg/24h), appearance of new lesion(s),>=50% increase from nadir in SPD of >1 lesion or >=50% increase in longest diameter of a previous lesion >1 centimeter (cm) in short axis.
PR: as defined in OM1.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Time to First Response (TT1R)
기간: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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TT1R was defined as the time from randomization to the date of first IRC determined response (PR or better) that was subsequently confirmed.
PR as per IMWG criteria was defined as >=50% reduction of serum M-protein and reduction in 24h urine M-protein by >=90% or to <200mg/24h.
In addition to above, if present at baseline, >=50% reduction in the size SPD of STPs was also required.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Time to Best Response (TTBR)
기간: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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TTBR was defined as the time from randomization to the date of first occurrence of IRC determined best overall response (PR or better) that was subsequently confirmed.
PR as per IMWG criteria was defined as >=50% reduction of serum M-protein and reduction in 24h urine M-protein by >=90% or to <200mg/24h.
In addition to above, if present at baseline,>=50% reduction in the size SPD of STPs was also required.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Progression-free Survival (PFS)
기간: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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PFS was defined as the time from the date of randomization to the date of first documentation of PD as determined by IRC or the date of death from any cause, whichever came first.
Responses were determined according to IMWG criteria.
PFS was censored at the date of the last valid disease assessment not showing PD performed prior to initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever came first.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Overall Survival (OS)
기간: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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OS was defined as the time from the date of randomization to death from any cause.
Participants without death prior to the analysis cut-off date were censored at the last date the participant was known to be alive or the cut-off date, whichever was first.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Progression Free Survival 2 (PFS2)
기간: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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PFS2 was defined as time from the date of randomization to the date of first documentation of PD (as assessed by Investigator) after initiation of further anti-myeloma treatment or death from any cause, whichever happened first.
Same censoring rule applies as in the PFS endpoint.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
기간: From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
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An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a medically important event.
TEAEs were defined as AEs that developed, worsened or became serious during the TE period.
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From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
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Isa-SC + Pd: Number of Participants With Injection Site Reactions (ISRs)
기간: From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
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The ISRs are defined as AEs related to medication administration with onset typically within 24 hours from the start of the infusion and are graded using NCI-CTCAE v5.0 criteria: Grade 1: tenderness with or without associated symptoms (warmth, erythema, itching).
Grade 2: pain; lipodystrophy; edema; phlebitis.
Grade 3: ulceration or necrosis severe tissue damage operative intervention indicated.
Grade 4: life-threatening consequences; urgent intervention indicated.
ISRs were collected through the eCRF.
Number of participants with at least 1 ISR is reported.
ISRs were applicable only for the SC administration.
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From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
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Isa-SC + Pd: Percentage of Successful Injections With Isatuximab Injector Device
기간: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Percentage of successful injections with investigational isatuximab injector device was defined as completion of administration per provided instructions for use with no use errors or technical issues divided by the total number of injections x 100.
Delivery performance of the device was analyzed based on the successful injection rate in the Isa-SC + Pd arm as the investigational isatuximab injector device was used only for SC administration.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Isatuximab
기간: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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A participant with treatment-emergent ADA was a participant with at least 1 treatment induced or treatment boosted ADA at any time during the treatment or follow-up observation period.
Treatment-induced ADA was defined as ADAs developed de novo (seroconversion) following administration of the biotherapeutic (ie, formation of ADAs any time after the initial study medication administration in a participant without pre-existing ADAs).
Treatment-boosted ADA was defined as pre-existing ADAs that were boosted to a higher level following administration of biotherapeutic (ie, any time after the initial study medication administration) the ADA titer was significantly higher than the baseline titer.
Number of participants with treatment-emergent ADAs is presented.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
기간: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation).
This questionnaire has been adapted based on qualitative interviews with oncology participants.
The responses to 'discomfort with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints.
Percentage of participants who disagreed and strongly disagreed that they experienced any discomfort with the injection method are reported here.
Percentages are rounded off to the tenth decimal place.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
기간: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation).
This questionnaire has been adapted based on qualitative interviews with oncology participants.
The responses to 'pain with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints.
Percentage of participants who disagreed and strongly disagreed that they experienced any pain with the injection method are reported here.
Percentages are rounded off to the tenth decimal place.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
기간: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation).
This questionnaire has been adapted based on qualitative interviews with oncology participants.
The responses to 'side effects with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints.
Percentage of participants who disagreed and strongly disagreed that they experienced any side effects with the injection method are reported here.
Percentages are rounded off to the tenth decimal place.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
기간: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation).
This questionnaire has been adapted based on qualitative interviews with oncology participants.
The responses to 'time saving with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints.
Percentage of participants who strongly agreed and agreed that they experienced time saving with the injection method are reported here.
Percentages are rounded off to the tenth decimal place.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
기간: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation).
This questionnaire has been adapted based on qualitative interviews with oncology participants.
The responses to 'satisfaction with injection method' were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints.
Percentage of participants who were very satisfied and satisfied with the injection method are reported here.
Percentages are rounded off to the tenth decimal place.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
기간: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation).
This questionnaire has been adapted based on qualitative interviews with oncology participants.
The responses to 'side effects with study medication' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints.
Percentage of participants who disagreed and strongly disagreed that they experienced any side effects with study medication are reported here.
Percentages are rounded off to the tenth decimal place.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
기간: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation).
This questionnaire has been adapted based on qualitative interviews with oncology participants.
The responses to 'study medication worth taking' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints.
Percentage of participants who strongly agreed and agreed that the study medication was worth taking are reported here.
Percentages are rounded off to the tenth decimal place.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
기간: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation).
This questionnaire has been adapted based on qualitative interviews with oncology participants.
The responses to satisfaction with study medication were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints.
Percentage of participants who were very satisfied and satisfied with the study medication are reported here.
Percentages are rounded off to the tenth decimal place.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
기간: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation).
This questionnaire has been adapted based on qualitative interviews with oncology participants.
The responses to 'recommendation of the study medication' were recorded as 'definitely yes, probably yes, unsure, probably not and definitely not' at specified timepoints.
Percentage of participants who responded definitely yes and probably yes to the recommendation of study medication are reported here.
Percentages are rounded off to the tenth decimal place.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants With Response to 'Patient Experience and Satisfaction End of Treatment Questionnaire (PESQ-EOT)'
기간: EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
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The PESQ-EOT consisting of 17 items assessed participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation) and has been adapted based on qualitative interviews with oncology participants.
In addition to the above, this questionnaire also includes additional items to assess whether participants received oncology medications in the past 2 years and if a participant received both IV and SC in the past 2 years, then participant preference on injection method (whether SC or IV).
Percentage of participants with response to these additional items (received oncology medications in the past 2 years via IV/SC/both and if received both IV and SC; then the participant preference on injection method) are reported here.
Percentages are rounded off to the tenth decimal place.
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EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
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Participant Responses to Patient's Assessment of Treatment (PAT) Questionnaire
기간: EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
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The 4-item PAT is an internally developed non-disease specific and self-administered assessment which has been debriefed with oncology patients during qualitative interviews.
It provided participant insights on the benefits and disadvantages of treatment.
Benefits and disadvantages were respectively rated on a 0-10 scale wherein 0=none (not beneficial at all or no disadvantages at all) and 10=maximum (extremely beneficial or extremely disadvantageous).
Disadvantages vs benefits were rated on a scale of -3 to 3 wherein -3=disadvantages significantly outweigh the benefits, 0=equal benefits and disadvantages and 3=benefits significantly outweigh the disadvantages.
Mean of benefits, disadvantages and disadvantages vs benefits is presented here.
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EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
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Duration of Hospital Visits for Treatment Administration and Duration of Post-Treatment Monitoring Based on HRUPQ
기간: From Cycle 2 Day 1 up to EOT visit (up to PCD: 06-Nov-2024) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
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Medical resource utilization was collected through HRUPQ.
Participants were asked to indicate the duration of their hospital visit (from arrival to departure) and the duration of post-treatment monitoring based on their most recent isatuximab administration.
The median duration across all visits (starting from Cycle 2) was calculated and reported here.
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From Cycle 2 Day 1 up to EOT visit (up to PCD: 06-Nov-2024) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
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Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
기간: Cycle 1 Days 8, 15 and 22, Cycle 2 Day 1, Cycles 3 to 29 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
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Medical resource utilization was collected through HRUPQ.
Percentage of participants with healthcare professional visit not required by clinical trial since last isatuximab administration was recorded.
Percentages are rounded off to the tenth decimal place.
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Cycle 1 Days 8, 15 and 22, Cycle 2 Day 1, Cycles 3 to 29 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
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Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For GHS/QoL: overall health and quality of life were assessed, rated on a 7-point scale (1: very poor to 7: excellent).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for GHS/QoL and a positive change from baseline represents a healthy/better level of QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Physical Functioning
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of physical functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Role Functioning
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of role functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Emotional Functioning
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of emotional functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of cognitive functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Social Functioning
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of social functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Fatigue
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Pain
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Dyspnea
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Insomnia
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Appetite Loss
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Constipation
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Diarrhea
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Financial Difficulties
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of financial difficulties.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for disease symptoms and a positive change from baseline represents more symptoms, worse QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for side effects of treatment and a positive change from baseline represents more side effects, worse QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-MY20: Future Perspective
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for future perspectives and a positive change from baseline represents better outcomes, better QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
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Change From Baseline in EORTC QLQ-MY20: Body Image
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for body image and a positive change from baseline represents better outcomes, better QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
기간: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
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The EQ-5D-5L is a standardized measure of health status that provides a simple, generic measure of health utility, and consists of 2 sections: descriptive and a VAS.
The descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
The VAS records the respondent's self-rated health on a 20-cm vertical scale ranging from 0: the worst health you can imagine to 100: the best health you can imagine.
Change from baseline in VAS is reported here.
A higher score in VAS and positive change from baseline represents a better level of QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
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ORR Based on at Least 1 Chromosomal Abnormality
기간: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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BM aspirate was collected for fluorescent in situ hybridization for analysis of del[17p], t[4;14], t[14;16]) and 1q21+.
ORR was also evaluated based on IRC assessment by disease characteristics.
ORR for participants with at least 1 chromosomal abnormality i.e. [del(17p)] or [1q21+ and t(4;14) or t(14;16)] is presented.
Percentages are rounded off to the tenth decimal place.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Clinical Sciences & Operations, Sanofi
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 6월 23일
기본 완료 (실제)
2024년 11월 6일
연구 완료 (추정된)
2027년 10월 22일
연구 등록 날짜
최초 제출
2022년 5월 31일
QC 기준을 충족하는 최초 제출
2022년 5월 31일
처음 게시됨 (실제)
2022년 6월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 10일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 혈관 질환
- 심혈관 질환
- 신생물
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 혈액 질환
- 림프 증식 장애
- 면역증식성 장애
- 지혈 장애
- 파라단백혈증
- 혈액 단백질 장애
- 출혈성 장애
- 다발성 골수종
- 신생물, 형질세포
- 유기 화학 물질
- 탄화수소
- 탄화수소, 순환
- 탄화수소, 방향족
- 다 환식 화합물
- Anilides
- 아미드
- 아닐린 화합물
- 아민
- 아세타 닐리 드
- Pretadienes
- 임신
- 스테로이드
- 융합 링 화합물
- 스테로이드, 불소
- 벤젠 유도체
- Pregnadienetriols
- 에틸 아민
- 프레드니솔론
- 벤츠 히드릴 화합물
- 덱사메타손
- 아세트아미노펜
- 메틸프레드니솔론
- 디펜히드라민
- Pomalidomide
- 이사 툭시 맙
- Montelukast
기타 연구 ID 번호
- EFC15951
- 2023 (미국 NIH 보조금/계약: GRAMMY Museum Foundation)
- U1111-1261-5846 (레지스트리 식별자: ICTRP)
- 2023-508869-32 (EudraCT 번호: CTIS)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
자격을 갖춘 연구원은 임상 연구 보고서, 수정된 연구 프로토콜, 백지 사례 보고서 양식, 통계 분석 계획 및 데이터 세트 사양을 포함하여 환자 수준 데이터 및 관련 연구 문서에 대한 액세스를 요청할 수 있습니다.
시험 참가자의 개인 정보를 보호하기 위해 환자 수준 데이터는 익명으로 처리되고 연구 문서는 편집됩니다.
Sanofi의 데이터 공유 기준, 적격 연구 및 액세스 요청 프로세스에 대한 자세한 내용은 https://vivli.org에서 확인할 수 있습니다.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .