재발성 또는 불응성 다발성 골수종 환자를 대상으로 한 Talquetamab 연구 (MonumenTAL-1)
재발성 또는 불응성 다발성 골수종 대상자에서 인간화 GPRC5D x CD3 이중특이성 항체인 Talquetamab의 임상 1/2상, 최초, 공개 라벨, 용량 증량 연구
The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
확장된 액세스
확장된 액세스
승인됨
- 사용 가능: 현재 이 연구 치료에 대해 확장된 액세스가 가능하며 임상 연구에 참여하지 않은 환자는 약물, 생물학적 제제 또는 의료 기기에 액세스할 수 있습니다. 연구 중입니다.
- 더 이상 사용할 수 없음: 이전에는 이 개입에 대해 확장된 액세스를 사용할 수 있었지만 현재 사용할 수 없으며 앞으로도 사용할 수 없습니다.
- 일시적으로 사용할 수 없음: 현재 이 개입에 대해 확장된 액세스를 사용할 수 없지만 향후 사용할 수 있을 것으로 예상됩니다.
- 마케팅 승인: 개입 대중이 사용할 수 있도록 미국 식품의약국(FDA)의 승인을 받았습니다.
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Study Contact
- 전화번호: 844-434-4210
- 이메일: Participate-In-This-Study1@its.jnj.com
연구 장소
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Amsterdam, 네덜란드, 1081 HV
- 완전한
- VU Medisch Centrum
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Utrecht, 네덜란드, 3584 CX
- 완전한
- UMCU
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Jeollanam-do, 대한민국, 58128
- 완전한
- Chonnam National University Hwasun Hospital
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Seoul, 대한민국, 06351
- 완전한
- Samsung Medical Center
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Seoul, 대한민국, 05505
- 완전한
- Asan Medical Center
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Seoul, 대한민국, 03080
- 완전한
- Seoul National University Hospital
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Seoul, 대한민국, 03722
- 완전한
- Severance Hospital Yonsei University Health System
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Seoul, 대한민국, 06591
- 완전한
- The Catholic University of Korea Seoul St Marys Hospital
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Berlin, 독일, 12203
- 모집하지 않고 적극적으로
- Charite Campus Benjamin Franklin
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Heidelberg, 독일, 69120
- 모집하지 않고 적극적으로
- Universitaetsklinikum Heidelberg
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Münster, 독일, 48149
- 완전한
- Universitaetsklinikum Muenster
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Würzburg, 독일, 97080
- 모집하지 않고 적극적으로
- Universitatsklinikum Wurzburg
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Alabama
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Birmingham, Alabama, 미국, 35294
- 모병
- University of Alabama Birmingham
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- 모병
- University of Arkansas for Medical Sciences
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California
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Duarte, California, 미국, 91010
- 완전한
- City of Hope
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Florida
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Hollywood, Florida, 미국, 33021
- 모병
- Memorial Healthcare System
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Georgia
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Atlanta, Georgia, 미국, 30322
- 모병
- Emory University Winship Cancer Institute
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Illinois
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Chicago, Illinois, 미국, 60637
- 완전한
- University of Chicago
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Kentucky
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Louisville, Kentucky, 미국, 40207
- 모병
- Norton Cancer Institute
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- 모병
- University of Michigan Health System
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Missouri
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St Louis, Missouri, 미국, 63110
- 모병
- Washington University School Of Medicine
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New York
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New York, New York, 미국, 10023
- 모병
- Mount Sinai Medical Center
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New York, New York, 미국, 10016
- 모집하지 않고 적극적으로
- NYU Langone Health
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Rochester, New York, 미국, 14642
- 모병
- University of Rochester Medical Center
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Oregon
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Portland, Oregon, 미국, 97213
- 완전한
- Providence Portland Medical Center
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Tennessee
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Nashville, Tennessee, 미국, 37203
- 완전한
- Tennessee Oncology
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Edegem, 벨기에, 2650
- 완전한
- UZ Antwerpen
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Leuven, 벨기에, 3000
- 모집하지 않고 적극적으로
- UZ Leuven
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Liège, 벨기에, 4000
- 모집하지 않고 적극적으로
- CHU de Liège - Domaine Universitaire du Sart Tilman
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Woluwe-Saint-Lambert, 벨기에, 1200
- 완전한
- UCL - Saint Luc
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Badalona, 스페인, 08916
- 완전한
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, 스페인, 8908
- 모집하지 않고 적극적으로
- Inst. Cat. Doncologia-H Duran I Reynals
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Barcelona, 스페인, 08035
- 모병
- Hosp Univ Vall D Hebron
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Madrid, 스페인, 28041
- 완전한
- Hosp. Univ. 12 de Octubre
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Madrid, 스페인, 28040
- 완전한
- Hosp Univ Fund Jimenez Diaz
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Murcia, 스페인, 30120
- 모집하지 않고 적극적으로
- Hosp. Univ. Virgen de La Arrixaca
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Pamplona, 스페인, 31008
- 모병
- Clinica Univ. de Navarra
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Pozuelo de Alarcón, 스페인, 28223
- 완전한
- Hosp. Quiron Madrid Pozuelo
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Salamanca, 스페인, 37007
- 모병
- Hosp Clinico Univ de Salamanca
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Santander, 스페인, 39008
- 모병
- Hosp. Univ. Marques de Valdecilla
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Seville, 스페인, 41013
- 모병
- Hosp. Virgen Del Rocio
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Haifa, 이스라엘, 31096
- 모집하지 않고 적극적으로
- Rambam Medical Center
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Haifa, 이스라엘, 3436212
- 모집하지 않고 적극적으로
- Carmel Medical Center
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Jerusalem, 이스라엘, 91120
- 모집하지 않고 적극적으로
- Hadassah Medical Center
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Ramat Gan, 이스라엘, 52621
- 모집하지 않고 적극적으로
- Sheba Medical Center
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Tel Aviv, 이스라엘, 64239
- 모집하지 않고 적극적으로
- Tel Aviv Sourasky Medical Center
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Chiba, 일본, 296-8602
- 완전한
- Kameda Medical Center
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Fukuoka, 일본, 814-0180
- 완전한
- Fukuoka University Hospital
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Gifu, 일본, 503-8502
- 완전한
- Ogaki Municipal Hospital
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Hokkaido, 일본, 006-8555
- 완전한
- Teine Keijinkai Hospital
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Kobe, 일본, 650 0047
- 완전한
- Kobe City Medical Center General Hospital
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Koshigaya, 일본, 343-8555
- 완전한
- Dokkyo Medical University Saitama Medical Center
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Kumamoto, 일본, 860-8556
- 완전한
- Kumamoto University Hospital
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Kurashiki, 일본, 710-8602
- 완전한
- Kurashiki Central Hospital
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Matsumoto, 일본, 399-8701
- 완전한
- National Hospital Organization Matsumoto Medical Center
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Okayama, 일본, 701-1192
- 완전한
- National Hospital Organization Okayama Medical Center
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Osaka, 일본, 543 8555
- 완전한
- Japanese Red Cross Osaka Hospital
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Shiwa-gun, 일본, 028-3695
- 완전한
- Iwate Medical University Hospital
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Ōtake, 일본, 739-0696
- 모집하지 않고 적극적으로
- National Hospital Organization Hiroshima-Nishi Medical Center
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Beijing, 중국, 100191
- 완전한
- Peking University Third Hospital
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Guangzhou, 중국, 510060
- 모집하지 않고 적극적으로
- Sun Yat Sen University Cancer Center
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Hangzhou, 중국, 310003
- 모집하지 않고 적극적으로
- The 1St Affiliated Hospital of Medical College Zhejiang University
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Hangzhou, 중국, 310003
- 모집하지 않고 적극적으로
- The 1st Affiliated Hospital Of Medical College Zhejiang University 1
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Suzhou, 중국, 215006
- 모집하지 않고 적극적으로
- First Affiliated Hospital SooChow University
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Tianjin, 중국, 300320
- 모집하지 않고 적극적으로
- Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
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Xi'an, 중국, 710004
- 완전한
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Xi'an, 중국, 710063
- 완전한
- The First Affiliated Hospital of Xian Jiaotong University
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Gdansk, 폴란드, 80 214
- 모집하지 않고 적극적으로
- Uniwersyteckie Centrum Kliniczne
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Gliwice, 폴란드, 44102
- 완전한
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
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Poznan, 폴란드, 60-569
- 모집하지 않고 적극적으로
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Warsaw, 폴란드, 02-781
- 완전한
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Wroclaw, 폴란드, 50 367
- 모집하지 않고 적극적으로
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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Créteil, 프랑스, 94000
- 모집하지 않고 적극적으로
- CHU Henri Mondor
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Lyon, 프랑스, 69002
- 모집하지 않고 적극적으로
- Hospices Civils de Lyon HCL
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Montpellier, 프랑스, 34295
- 모집하지 않고 적극적으로
- CHU de Montpellier Hopital Saint Eloi
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Nantes, 프랑스, 44093
- 모집하지 않고 적극적으로
- C.H.U. Hotel Dieu - France
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Pessac, 프랑스, 33604
- 모집하지 않고 적극적으로
- CHU de Bordeaux - Hospital Haut-Leveque
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Toulouse, 프랑스, 31059
- 모집하지 않고 적극적으로
- Pôle IUC Oncopole CHU
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
- Part 3: Measurable disease cohort A, cohort B, cohort C and cohort D: multiple myeloma must be measurable by central laboratory assessment; Cohort E: Multiple myeloma must be measurable by local laboratory assessment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin [hCG]) or urine
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
Exclusion Criteria:
- Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B, Cohort D and Cohort E: T cell redirection therapy within 3 months
- Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
- Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
- Stroke or seizure within 6 months prior to signing the informed consent form (ICF)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Part 3: Cohort A (Talquetamab)
Cohort A will enroll participants with multiple myeloma who have previously received greater than or equal to (>=) 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to open-label extension (OLE) phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the long-term extension (LTE) and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
다른 이름들:
|
|
실험적: Part 3: Cohort B (Talquetamab)
Cohort B will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
다른 이름들:
|
|
실험적: Part 3: Cohort C (Talquetamab)
Cohort C will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
다른 이름들:
|
|
실험적: Part 3: Cohort D (Talquetamab)
Cohort D will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants in this cohort will receive tocilizumab prophylaxis for cytokine release syndrome (CRS) including all outpatient dosing. Participants will transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
다른 이름들:
|
|
실험적: Part 3: Cohort E (Talquetamab)
Cohort E will enroll participants with multiple myeloma who have previously received at least 1 proteasome inhibitor (PI), 1 immunomodulatory imide drug (IMiD), and 1 anti-cluster of differentiation 38 (CD38) monoclonal antibody. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants will receive tocilizumab prophylaxis for CRS with consolidated priming dose schedules as well as possible transition to outpatient priming dosing transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Response Rate (ORR)
기간: Up to 2 years and 10 months
|
ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria. |
Up to 2 years and 10 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Duration of Response (DOR)
기간: Up to 2 years and 10 months
|
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria, or death due to PD, whichever occurs first. |
Up to 2 years and 10 months
|
|
Very Good Partial Response (VGPR) or Better Rate
기간: Up to 2 years and 10 months
|
VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria. |
Up to 2 years and 10 months
|
|
Complete Response (CR) or Better Rate
기간: Up to 2 years and 10 months
|
CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria. |
Up to 2 years and 10 months
|
|
Stringent Complete Response (sCR) Rate
기간: Up to 2 years and 10 months
|
sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria. |
Up to 2 years and 10 months
|
|
Time to Response (TTR)
기간: Up to 2 years and 10 months
|
TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better. |
Up to 2 years and 10 months
|
|
Progression-Free Survival (PFS)
기간: Up to 2 years and 10 months
|
PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first. |
Up to 2 years and 10 months
|
|
Overall Survival (OS)
기간: Up to 2 years and 10 months
|
OS is defined as the time from the date of first dose of study drug to the date of the participant's death. |
Up to 2 years and 10 months
|
|
Minimal Residual Disease (MRD) Negative Rate
기간: Up to 2 years and 10 months
|
MRD negativity rate is measured only for participants who achieve at least a CR but is reported based on all treated similar to the other response data. |
Up to 2 years and 10 months
|
|
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
기간: Up to 2 years and 10 months
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
Up to 2 years and 10 months
|
|
Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
기간: Up to 2 years and 10 months
|
An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. |
Up to 2 years and 10 months
|
|
Number of Participants with AEs by Severity
기간: Up to 2 years and 10 months
|
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event. |
Up to 2 years and 10 months
|
|
Number of Participants with Abnormalities in Clinical Laboratory Values
기간: Up to 2 years and 10 months
|
Number of participants with abnormalities in clinical laboratory values (such as hematology, serum chemistry and coagulation) will be reported. |
Up to 2 years and 10 months
|
|
Serum Concentration of Talquetamab
기간: Up to 2 years and 10 months
|
Serum samples will be analyzed to determine concentrations of talquetamab. |
Up to 2 years and 10 months
|
|
Number of Participants with Talquetamab Antibodies
기간: Up to 2 years and 10 months
|
Antibodies to talquetamab will be assessed to evaluate potential immunogenicity. |
Up to 2 years and 10 months
|
|
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)
기간: Baseline up to 2 years and 10 months
|
The EORTC- QLQ-Core-30 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week ("past week") and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms. |
Baseline up to 2 years and 10 months
|
|
Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
기간: Baseline up to 2 years and 10 months
|
The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers. |
Baseline up to 2 years and 10 months
|
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Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)
기간: Baseline up to 2 years and 10 months
|
The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe). |
Baseline up to 2 years and 10 months
|
|
Overall Response Rate (ORR) in Participants with High-risk Molecular Features
기간: Up to 2 years and 10 months
|
ORR in participants with high risk is defined as the overall response rate among the high risk molecular subgroups or other high-risk molecular subtypes. |
Up to 2 years and 10 months
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
간행물 및 유용한 링크
일반 간행물
- Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez-Lopez J, Rodriguez-Otero P, Dytfeld D, Diels J, Strulev V, Haddad I, Renaud T, Ammann E, Cabrieto J, Perualila N, Gan R, Zhang Y, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Current Treatments in the LocoMMotion and MoMMent Studies in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Apr;41(4):1576-1593. doi: 10.1007/s12325-024-02797-x. Epub 2024 Feb 24.
- Schinke C, Touzeau C, Oriol A, Mateos MV, Stevens D, Rasche L, Qin X, Kato K, Bathija S, Katz EG, Gries KS, Campagna M, Masterson T, Hilder BW, Tolbert J, Renaud T, Heuck C, Tomlinson C, Moreau P, San-Miguel J, Rodriguez-Otero P, Chari A. Talquetamab improves patient-reported symptoms and health-related quality of life in relapsed or refractory multiple myeloma: Results from the phase 1/2 MonumenTAL-1 study. Cancer. 2025 Jul 15;131(14):e35927. doi: 10.1002/cncr.35927.
- Chari A, Touzeau C, Schinke C, Minnema MC, Berdeja JG, Oriol A, van de Donk NWCJ, Rodriguez-Otero P, Morillo D, Martinez-Chamorro C, Mateos MV, Costa LJ, Caers J, Rasche L, Krishnan A, Ye JC, Karlin L, Lipe B, Vishwamitra D, Skerget S, Verona R, Ma X, Qin X, Ludlage H, Campagna M, Masterson T, Hilder B, Tolbert J, Renaud T, Goldberg JD, Kane C, Heuck C, San-Miguel J, Moreau P. Safety and activity of talquetamab in patients with relapsed or refractory multiple myeloma (MonumenTAL-1): a multicentre, open-label, phase 1-2 study. Lancet Haematol. 2025 Apr;12(4):e269-e281. doi: 10.1016/S2352-3026(24)00385-5. Epub 2025 Mar 13.
- van de Donk NWCJ, Chari A, Martin T, Krishnan A, Rasche L, Ye JC, Popat R, Lipe B, Rodriguez C, Schinke C, Skerget S, Vishwamitra D, Verona R, Gong J, Singh I, Campagna M, Masterson T, Hilder B, Tolbert J, Renaud T, Smit MD, Heuck C, Mateos MV. Characterization and Management of Cytokine Release Syndrome From the MonumenTAL-1 Study of Talquetamab in Patients With Relapsed/Refractory Multiple Myeloma. Cancer Med. 2025 Oct;14(19):e71276. doi: 10.1002/cam4.71276.
- Schinke C, Rodriguez-Otero P, van de Donk NWCJ, Lipe B, Lavi N, Rasche L, Parekh S, Van Oekelen O, Vishwamitra D, Skerget S, Cortes-Selva D, Verona R, Hilder B, Masterson T, Campagna M, Khedkar S, Renaud T, Tolbert J, Kane C, Gray KS, Saber I, Heuck C, Chari A. Infections and parameters of humoral immunity with talquetamab in relapsed/refractory multiple myeloma in MonumenTAL-1. Blood Adv. 2025 Nov 25;9(22):5752-5762. doi: 10.1182/bloodadvances.2025016613.
- Catamero D, Ray C, Purcell K, Leahey S, Esler E, Rogers S, Hefner K, O'Rourke L, Gray K, Tolbert J, Renaud T, Patel S, Hannemann L, Shenoy S. Nursing Considerations for the Clinical Management of Adverse Events Associated with Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma. Semin Oncol Nurs. 2024 Oct;40(5):151712. doi: 10.1016/j.soncn.2024.151712. Epub 2024 Aug 17.
- Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez Lopez J, Rodriguez-Otero P, Dytfeld D, Jakubowiak A, Schinke C, Besemer B, Anguille S, Manier S, Rasche L, Teipel R, Scheid C, Pawlyn C, Cavo M, Diels J, Ghilotti F, Lau BW, Renaud T, Orel O, Ong F, Ramos DF, Ammann E, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Real-World Physician's Choice of Treatment in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma: Updated Analyses of MonumenTAL-1 vs. LocoMMotion/MoMMent. Adv Ther. 2026 Jan;43(1):333-355. doi: 10.1007/s12325-025-03409-y. Epub 2025 Nov 28.
- Ito S, Kuroda Y, Sunami K, Matsue K, Imada K, Tamura H, Fujikawa E, Yamazaki H, Takamoto M, Pei L, Qin X, Masterson TJ, Campagna M, Vreys V, Lau BW, Takamatsu Y. Talquetamab in Japanese patients with relapsed/refractory multiple myeloma in the MonumenTAL-1 study. Int J Hematol. 2026 Apr;123(4):580-592. doi: 10.1007/s12185-025-04134-6. Epub 2025 Dec 17.
- Rasche L, Schinke C, Touzeau C, Minnema MC, van de Donk N, Rodriguez-Otero P, Mateos MV, Ye JC, Tomlinson C, Vishwamitra D, Singh I, Qin X, Campagna M, Masterson T, Vreys V, Lau BW, Tolbert J, Renaud T, Heuck C, Chari A. Talquetamab in patients with relapsed/refractory multiple myeloma: 3-year follow-up of the phase 1/2 MonumenTAL-1 study. Blood. 2026 Aug 6:blood.2025031994. doi: 10.1182/blood.2025031994. Online ahead of print.
- Schinke C, Touzeau C, Oriol A, Mateos MV, Stevens D, Rasche L, Moreau P, San-Miguel J, Rodriguez-Otero P, Kato K, Bathija S, Katz EG, Masterson T, Tomlinson C, Chari A. A plain language summary describing how talquetamab affects the way people with multiple myeloma feel and function in the MonumenTAL-1 study. Future Oncol. 2026 Jun;22(14):1651-1668. doi: 10.1080/14796694.2026.2669331. Epub 2026 Jun 16.
- Chari A, Touzeau C, Berdeja JG, Oriol A, van de Donk NW, Rodriguez-Otero P, Morillo D, Martinez-Chamorro C, Mateos MV, Costa LJ, Caers J, Rasche L, Krishnan A, Ye JC, Karlin L, Lipe B, Masterton T, Tolbert J, Renaud T, Kane C, Heuck C, Moreau P. Talquetamab for people living with relapsed/ refractory multiple myeloma: plain language summary of the MonumenTAL-1 study. Future Oncol. 2026 Aug 30:1-20. doi: 10.1080/14796694.2026.2709901. Online ahead of print.
- Schinke C, Rodriguez-Otero P, van de Donk NWCJ, Lipe B, Lavi N, Rasche L, Cortes-Selva D, Masterson T, Khedkar S, Tolbert J, Kane C, Saber I, Heuck C, Chari A. Infections in MonumenTAL-1: a plain language summary of talquetamab treatment for relapsed/refractory multiple myeloma. Future Oncol. 2026 Sep 28:1-16. doi: 10.1080/14796694.2026.2722559. Online ahead of print.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- CR108920
- 2017-002400-26 (EudraCT 번호)
- TALMMY1001-PT3 (기타 식별자: Janssen Research & Development, LLC)
- 2017 (미국 NIH 보조금/계약)
- 2023-504581-29-00 (레지스트리 식별자: EUCT number)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .