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Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

2022년 9월 8일 업데이트: Amgen

A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens for adults with relapsed multiple myeloma. Eligible subjects will be randomized in a 1:1 ratio to receive either the control Rd or CRd. Randomization will be stratified by β2 microglobulin levels (< vs ≥ 2.5 mg/L), prior bortezomib (no vs yes), and prior lenalidomide (no vs yes). Participants will receive the treatment determined by randomization in 28-day cycles until disease progression or unacceptable toxicity (whichever occurs first).

연구 유형

중재적

등록 (실제)

792

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 그리스
      • Athens, 그리스, 11528
        • Alexandra Hospital
      • Patras, 그리스, 26500
        • University General Hospital of Patras
  • 네덜란드
      • Rotterdam, 네덜란드, 3015 CE
        • Erasmus MC, Department of Haematology
  • 독일
      • Dusseldorf, 독일, 40225
        • University of Dusseldorf
      • Frankfurt am Main, 독일, 60488
        • Krankenhaus Nordwest
      • Hamburg, 독일, 20246
        • University of Hamburg-Eppendorf
      • Heidelberg, 독일, 69120
        • Universität Heidelberg
      • Koblenz, 독일, 56068
        • Stiftungsklinikum Mittelrhein
      • Munchen, 독일, 81377
        • LMU Klinikum der Universität
      • Munster, 독일, 48129
        • Universitätsklinikum Münster
      • Wurzburg, 독일, 97080
        • Universitätsklinikum Würzburg
  • 러시아 연방
      • Izhevsk, 러시아 연방, 426039
        • First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia
      • Moscow, 러시아 연방, 115478
        • Federal State Budgetary Scientific Institution: N.N. Blokhin Russian Cancer Research Center
      • Moscow, 러시아 연방, 125101
        • Moscow State Medical Institution Municipal City Clinical Hospital n.a. S.P. Botkin
      • Moscow, 러시아 연방, 125167
        • Federal State Budget Institution: Hematology Research Center under MoH
      • St. Petersburg, 러시아 연방, 191024
        • FSBI: Russian Research Institute of Hematology and Blood Transfusion under the Ferderal Agency for M&B
      • St. Petersburg, 러시아 연방, 197022
        • State Higher Educational Institution: St Petersburg State Medical University n.a.I.P Pavlov
      • St. Petersburg, 러시아 연방, 197101
        • SHEI: First St. Petersburg State Medical University N.a.I.P Pavlov under MoH, Clinic of Bone Marrow Transplant
      • St. Petersburg, 러시아 연방, 197341
        • Federal State Budget Institute: Federal Almalov Medical Research Centre under Ministry of Healthcare
    • Komi Republic
      • Syktyvkar, Komi Republic, 러시아 연방, 167904
        • State Medical Institution Komi Republican Oncological Center
  • 루마니아
      • Bucharest, 루마니아, 022328
        • Fundeni Clinical Institute, "Stefan Berceanu" Center for Hematology and Bone Marrow Transplantation
      • Bucharest, 루마니아, 030-171
        • Coltea Clinical Hospital
      • Bucharest, 루마니아, 050098
        • Bucharest University Emergency Hospital
      • Iasi, 루마니아, 700483
        • Regional Institute of Iasi
  • 미국
    • Arizona
      • Scottsdale, Arizona, 미국, 85259
        • Mayo Clinic
    • California
      • Burbank, California, 미국, 91505
        • Providence St. Joseph Medical Center
      • Santa Rosa, California, 미국, 94503
        • St. Jude Hospital Yorba Linda dba; St. Joseph Heritage Healthcare
      • Stanford, California, 미국, 94305
        • Stanford University
    • Colorado
      • Denver, Colorado, 미국, 80218
        • Colorado Blood Cancer Institute
    • Florida
      • Lecanto, Florida, 미국, 34461
        • Cancer and Blood Disease Center
    • Illinois
      • Chicago, Illinois, 미국, 60612
        • Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, 미국, 46202
        • Indiana University Health Melvin and Bren Simon Cancer Center
    • Kansas
      • Kansas City, Kansas, 미국, 66160
        • University of Kansas Cancer Center
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
        • The University of Michigan - Comprehensive Cancer Center
    • Minnesota
      • Rochester, Minnesota, 미국, 55905
        • Mayo Clinic
    • New Jersey
      • Hackensack, New Jersey, 미국, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
    • New York
      • New York, New York, 미국, 10016
        • Nyu Clinical Cancer Center
      • New York, New York, 미국, 10021
        • Weill Cornell Medical College
    • Tennessee
      • Chattanooga, Tennessee, 미국, 37404
        • Associates in Oncology and Hematology
    • Texas
      • Amarillo, Texas, 미국, 79106
        • The Don & Sybil Harrington Cancer Center
      • Dallas, Texas, 미국, 75246
        • Baylor Sammons Cancer Center
      • Dallas, Texas, 미국, 75390-8565
        • UT Southwestern Medical Center at Dallas
      • Houston, Texas, 미국, 77030
        • The University of Texas, MD Anderson Cancer Center
      • Temple, Texas, 미국, 76508
        • Scott and White Memorial Hospital
    • Washington
      • Seattle, Washington, 미국, 98109
        • Fred Hutchinson Cancer Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, 미국, 53226
        • Froedtert & Medical College of Wisconsin
  • 벨기에
      • Antwerpen, 벨기에, 2060
        • Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
      • Brugge, 벨기에, 8000
        • AZ Sint-Jan AV
      • Brussels, 벨기에, 1090
        • UZ Brussel
      • Bruxelles, 벨기에, 1000
        • Institut Jules Bordet
      • Bruxelles, 벨기에, 1200
        • Cliniques Universitaires Saint-Luc
      • Leuven, 벨기에, 3000
        • UZ Leuven
  • 불가리아
      • Pleven, 불가리아, 5800
        • University Multiprofile Hospital for Active Treatment, "Dr. Georgi Stranski"
      • Plovdiv, 불가리아, 4002
        • University Multiprofile Hospital for Active Treatment "Sveti Georgi"
      • Sofia, 불가리아, 1606
        • Military Medical Academy Multiprofile Hospital for Active Treatment
      • Sofia, 불가리아, 1756
        • Specialized Hospital for Active Treatment of Hematological Diseases
      • Varna, 불가리아, 9010
        • Multiprofile Hospital for Active Treatment "Sveta Marina"
  • 세르비아
      • Belgrade, 세르비아, 11000
        • Clinical Center of Serbia, Clinic of Hematology
      • Belgrade, 세르비아, 11000
        • Clinical Hospital Center Bezanijska Kosa
      • Belgrade, 세르비아, 11000
        • Military Medical Academy, Clinic of Hematology
      • Nis, 세르비아, 18 000
        • Clinical Center Nis, Clinic of Hematology
      • Novi Sad, 세르비아, 21 000
        • Clinical Center of Vojvodina, Clinic of Hematology
  • 스웨덴
      • Goteborg, 스웨덴, SE-41345
        • Sahlgrenska Universitetssjukhuset
      • Stockholm, 스웨덴, SE-14186
        • Karolinska Universitetsjukhuset i Huddinge
      • Stockholm, 스웨덴, SE-17176
        • Karolinska Universitetssjukhuset Solna, Hematologiskt Centrum
  • 스페인
      • Badalona, 스페인, 08916
        • Hospital Universitario Germans Trias i Pujol
      • Barcelona, 스페인, 08036
        • Hospital Clinic i Provincial
      • Salamanca, 스페인, 37007
        • Hospital Universitario de Salamanca
      • San Sebastian, 스페인, 20014
        • Hospital Donostia
      • Valencia, 스페인, 46026
        • Hospital Universitario y Politeecnico La Fe
      • Zaragoza, 스페인, 50009
        • Hospital Universitario Miguel Servet
  • 영국
      • London, 영국, SW17 0QT
        • St. Georges Hospital
      • London, 영국, EC1A 7BE
        • St. Bartholomew's Hospital
      • London, 영국, NW3 2QG
        • Royal Free Hampstead
      • Nottingham, 영국, NG5 1PB
        • Nottingham University Hospitals (City Campus)
      • Sutton, 영국, SM2 5PT
        • Royal Marsden Hospital
      • Wolverhampton, 영국, WV10 OQP
        • The Royal Wolverhampton Hospital NHS Trust
  • 오스트리아
      • Wien, 오스트리아, 1090
        • Medizinische Universität Wien
      • Wien, 오스트리아, 1171
        • Wilhelminspital der Stadt Wien, Zentrum fur Onkologie und Hamatologie
  • 이스라엘
      • Haifa, 이스라엘, 31096
        • Rambam Medical Center
      • Jerusalem, 이스라엘, 91120
        • Hadassah Medical Center, Ein Kerem
      • Nahariya, 이스라엘, 22100
        • Western Gailee Hospital - Nahariya
      • Petach Tikva, 이스라엘, 49100
        • Rabin Medical Center
      • Ramat Gan, 이스라엘, 52621
        • The Chaim Sheba Medical Center
      • Rehovot, 이스라엘, 76100
        • Kaplan Medical Center
  • 이탈리아
      • Milano, 이탈리아, 20162
        • Azienda Ospedallera Niguarda Ca Granda
      • Novara, 이탈리아, 28100
        • Azienda Ospedllero Maggiore della Carita
      • Pisa, 이탈리아, 56216
        • Azienda Ospedaliera Pisana Ospendale Santa Chiara - Main
      • Roma, 이탈리아, 00144
        • Ospedale S. Eugenio
      • Torino, 이탈리아, 10126
        • Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
  • 체코
      • Brno, 체코, 625 00
        • University Hospital Brno, Department of Internal Medicine - Hematooncology
      • Hradec Kralove, 체코, 500 05
        • University Hospital Hradec Kralove
      • Olomouc, 체코, 775 20
        • University hospital Olomouc
      • Praha 10, 체코, 100 34
        • University Hospital Kralovske Vinohrady - Prague
      • Praha 2, 체코, 128 08
        • General University Hospital Prague
  • 캐나다
    • Alberta
      • Calgary, Alberta, 캐나다, T2N 4N2
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, 캐나다, T6G 1Z2
        • University of Alberta, Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, 캐나다, V5Z 1M9
        • Vancouver General Hospital
    • Manitoba
      • Winnipeg, Manitoba, 캐나다, R3E 0V9
        • Cancer Care Manitoba
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, 캐나다, A1B 3V6
        • General Hospital, Health Sciences Centre
    • Ontario
      • Toronto, Ontario, 캐나다, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, 캐나다, H3A 1A1
        • McGill University Health Center, Royal Victoria Hospital
      • Montreal, Quebec, 캐나다, H3T 1E2
        • Sir Mortimer B. Davis - Jewish General Hospital
  • 폴란드
      • Gdansk, 폴란드, 80-952
        • University Clinical Centre, Department of Hematologii Transplantologii
      • Gorzow Wielkopolski, 폴란드, 66-400
        • Samodzielny Publ. Szp. Wojewodzki w Gorzow Wlkp.
      • Katowice, 폴란드, 40-027
        • Independent Public Teaching Hospital of Medical University of Silesia in Katowice
      • Lodz, 폴란드, 93-510
        • Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz
      • Suwalki, 폴란드, 16-400
        • Szpital Wojewwodzki im. dr Ludwika Rydygiera w Suwalkach
      • Torun, 폴란드, 87-100
        • Nicolaus Copernicus Municipal Specialist Hospital
      • Warszawa, 폴란드, 02-781
        • Maria Sklodowska-Curie Institute of Oncology
      • Zamosc, 폴란드, 22-400
        • Zamojski Non-Public Hospital
  • 프랑스
      • Clamart, 프랑스, 92140
        • Hospital Antoine Beclere
      • Le Mans, 프랑스, 72000
        • Clinique Victor Hugo - Centre Jean Bernard
      • Lille, 프랑스, 59037
        • Hôpital Claude Huriez
      • Mulhouse, 프랑스, 68070
        • CH de Mulhouse, Hopital Emile Muller
      • Nantes, 프랑스, 44093
        • CHU Nantes Hôtel Dieu
      • Paris, 프랑스, 75012
        • Hôpital Saint-Antoine
      • Paris, 프랑스, 75015
        • Groupe Hospitalier Necker - Enfants Malades
      • Toulouse, 프랑스, 31100
        • Cancer Institut Universitaire de Toulouse-Oncopole (iUCT)
      • Vandoeuvre-Les-Nancy, 프랑스, 54511
        • Hopitaux de Brabois
  • 헝가리
      • Budapest, 헝가리, H-1097
        • St. Istvan and St. Laszlo Hospital of Budapest
      • Debrecen, 헝가리, H-4032
        • University of Debrecen, Medical and Health Science Center
      • Gyor, 헝가리, H-9032
        • Petz Aladar County Teaching Hospital
      • Gyula, 헝가리, H-5700
        • Bekes County Pandy Kalman Hospital
      • Kaposvar, 헝가리, H-7400
        • Kaposi Mór County Teaching Hospital
      • Pecs, 헝가리, H-7624
        • University of Pecs
      • Szeged, 헝가리, H-6720
        • University of Szeged, Albert Szent-Gyorgi Clinical Center

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

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Symptomatic multiple myeloma

  2. Measurable disease, as defined by one or more of the following (assessed within 21 days prior to randomization):

    • Serum M-protein ≥ 0.5 g/dL
    • Urine Bence-Jones protein ≥ 200 mg/24 hours
    • For immunoglobulin A (IgA) patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL)
  3. Prior treatment with at least one, but no more than three, regimens for multiple myeloma
  4. Documented relapse or progressive disease on or after any regimen
  5. Achieved a response to at least one prior regimen
  6. Age ≥ 18 years
  7. Life expectancy ≥ 3 months
  8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  9. Adequate hepatic function, with serum alanine aminotransferase (ALT) ≤ 3.5 times the upper limit of normal and serum direct bilirubin ≤ 2 mg/dL (34 µmol/L) within 21 days prior to randomization
  10. Absolute neutrophil count ≥ 1.0 × 10^9/L within 21 days prior to randomization
  11. Hemoglobin ≥ 8 g/dL (80 g/L) within 21 days prior to randomization
  12. Platelet count ≥ 50 × 10^9/L (≥ 30 × 10^9/L if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization
  13. Creatinine clearance (CrCl) ≥ 50 mL/minute within 21 days prior to randomization
  14. Written informed consent in accordance with federal, local, and institutional guidelines
  15. Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception
  16. Male subjects must agree to practice contraception

Exclusion Criteria:

  1. If previously treated with bortezomib (alone or in combination), progression during treatment

  2. If previously treated with a lenalidomide and dexamethasone (len/dex) combination:

    • Progression during the first 3 months of initiating treatment
    • Any progression during treatment if the len/dex combination was the subject's most recent line of therapy
  3. Discontinuation of previous lenalidomide or dexamethasone due to intolerance; subjects intolerant to bortezomib are not excluded
  4. Prior carfilzomib treatment
  5. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  6. Waldenström's macroglobulinemia or IgM myeloma
  7. Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
  8. Chemotherapy or investigational agent within 3 weeks prior to randomization or antibody therapy within 6 weeks prior to randomization
  9. Radiotherapy to multiple sites or immunotherapy/antibody therapy within 28 days prior to randomization; localized radiotherapy to a single site within 7 days prior to randomization
  10. Corticosteroid therapy at a dose equivalent to dexamethasone > 4 mg/day within 21 days prior to randomization
  11. Pregnant or lactating females
  12. Major surgery within 21 days prior to randomization
  13. Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomization
  14. Known human immunodeficiency virus infection
  15. Active hepatitis B or C infection
  16. Myocardial infarction within 4 months prior to randomization, New York Hear Association (NYHA) Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
  17. Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization
  18. Other malignancy, including myelodysplastic syndromes (MDS), within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
  19. Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to randomization
  20. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
  21. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
  22. Ongoing graft-vs-host disease
  23. Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization
  24. Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

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
활성 비교기: Lenalidomide and Dexamethasone (Rd)
Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22.
의약품: 레날리도마이드
1-21일에 구두로 25mg
다른 이름들:
  • 레블리미드
의약품: Dexamethasone
40 mg orally or IV on days 1, 8, 15, 22
실험적: Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, escalating to 27 mg/m² on days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 from cycle 1 through cycle 18 and from cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 from cycle 1 through cycle 18 and from cycle 19 and higher.
의약품: 레날리도마이드
1-21일에 구두로 25mg
다른 이름들:
  • 레블리미드
의약품: Dexamethasone
40 mg orally or IV on days 1, 8, 15, 22
의약품: Carfilzomib
20 mg/m², 27 mg/m² intravenously
다른 이름들:
  • PR-171
  • 키프롤리스®

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression-free Survival (PFS)
기간: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).
From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival
기간: From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.
Overall survival (OS) was defined as the duration from randomization to death due to any cause. Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier.
From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.
Overall Response Rate
기간: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Overall response rate is defined as the percentage of participants who achieved either a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).
From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Disease Control Rate
기간: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Disease control rate was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria).
From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Duration of Response
기간: From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.
Duration of response (DOR) was calculated for participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.
Duration of Disease Control
기간: From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.
Duration of disease control (DDC) was calculated for participants who achieved disease control. DDC was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.
Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores
기간: Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18
Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life.
Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18

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스폰서

Amgen

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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)

2010년 7월 14일

기본 완료 (실제)

2014년 6월 16일

연구 완료 (실제)

2017년 12월 5일

연구 등록 날짜

최초 제출

2010년 3월 2일

QC 기준을 충족하는 최초 제출

2010년 3월 2일

처음 게시됨 (추정)

2010년 3월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 9월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 9월 8일

마지막으로 확인됨

2022년 9월 1일

추가 정보

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키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PX-171-009

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