A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
MonumenTAL-1
A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma
4 other identifiers
interventional
510
11 countries
78
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2021
Longer than P75 for phase_2
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2020
CompletedFirst Posted
Study publicly available on registry
November 18, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2029
ExpectedApril 13, 2026
April 1, 2026
5.2 years
November 16, 2020
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
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
Secondary Outcomes (18)
Duration of Response (DOR)
Up to 2 years and 10 months
Very Good Partial Response (VGPR) or Better Rate
Up to 2 years and 10 months
Complete Response (CR) or Better Rate
Up to 2 years and 10 months
Stringent Complete Response (sCR) Rate
Up to 2 years and 10 months
Time to Response (TTR)
Up to 2 years and 10 months
- +13 more secondary outcomes
Study Arms (5)
Part 3: Cohort A (Talquetamab)
EXPERIMENTALCohort 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.
Part 3: Cohort B (Talquetamab)
EXPERIMENTALCohort 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.
Part 3: Cohort C (Talquetamab)
EXPERIMENTALCohort 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.
Part 3: Cohort D (Talquetamab)
EXPERIMENTALCohort 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.
Part 3: Cohort E (Talquetamab)
EXPERIMENTALCohort 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.
Interventions
Talquetamab will be administered SC until disease progression.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
University of Alabama Birmingham
Birmingham, Alabama, 35294, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
City of Hope
Duarte, California, 91010, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
NYU Langone Health
New York, New York, 10016, United States
Mount Sinai Medical Center
New York, New York, 10023, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
UZ Antwerpen
Edegem, 2650, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
UCL - Saint Luc
Woluwe-Saint-Lambert, 1200, Belgium
Peking University Third Hospital
Beijing, 100191, China
Sun Yat Sen University Cancer Center
Guangzhou, 510060, China
The 1st Affiliated Hospital Of Medical College Zhejiang University 1
Hangzhou, 310003, China
The 1St Affiliated Hospital of Medical College Zhejiang University
Hangzhou, 310003, China
First Affiliated Hospital SooChow University
Suzhou, 215006, China
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
Tianjin, 300320, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710063, China
CHU Henri Mondor
Créteil, 94000, France
Hospices Civils de Lyon HCL
Lyon, 69002, France
CHU de Montpellier Hopital Saint Eloi
Montpellier, 34295, France
C.H.U. Hotel Dieu - France
Nantes, 44093, France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, 33604, France
Pôle IUC Oncopole CHU
Toulouse, 31059, France
Charite Campus Benjamin Franklin
Berlin, 12203, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Universitatsklinikum Wurzburg
Würzburg, 97080, Germany
Rambam Medical Center
Haifa, 31096, Israel
Carmel Medical Center
Haifa, 3436212, Israel
Hadassah Medical Center
Jerusalem, 91120, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Kameda Medical Center
Chiba, 296-8602, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Ogaki Municipal Hospital
Gifu, 503-8502, Japan
Teine Keijinkai Hospital
Hokkaido, 006-8555, Japan
Kobe City Medical Center General Hospital
Kobe, 650 0047, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, 343-8555, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Kurashiki Central Hospital
Kurashiki, 710-8602, Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto, 399-8701, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Japanese Red Cross Osaka Hospital
Osaka, 543 8555, Japan
National Hospital Organization Hiroshima-Nishi Medical Center
Ōtake, 739-0696, Japan
Iwate Medical University Hospital
Shiwa-gun, 028-3695, Japan
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
UMCU
Utrecht, 3584 CX, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 214, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
Gliwice, 44102, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, 50 367, Poland
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, 8908, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, 28040, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. Virgen de La Arrixaca
Murcia, 30120, Spain
Clinica Univ. de Navarra
Pamplona, 31008, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, 28223, Spain
Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Related Publications (8)
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. 2025 Dec 17. doi: 10.1007/s12185-025-04134-6. Online ahead of print.
PMID: 41405810DERIVEDEinsele 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.
PMID: 41313549DERIVEDvan 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.
PMID: 41036677DERIVEDSchinke 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.
PMID: 40864183DERIVEDSchinke 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.
PMID: 40631904DERIVEDChari 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.
PMID: 40090350DERIVEDCatamero 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.
PMID: 39155155DERIVEDEinsele 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.
PMID: 38402374DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
November 16, 2020
First Posted
November 18, 2020
Study Start
February 1, 2021
Primary Completion
March 31, 2026
Study Completion (Estimated)
March 30, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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