Talquetamab in Japanese patients with relapsed/refractory multiple myeloma in the MonumenTAL-1 study.
Shigeki Ito, Yoshiaki Kuroda, Kazutaka Sunami...
https://pubmed.ncbi.nlm.nih.gov/41405810Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04634552
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
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
510
Participants Needed
78
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of talquetamab in people with relapsed or refractory multiple myeloma who have received multiple prior treatments. This study focuses on participants who have had at least three previous therapy lines, including some who have been exposed to T cell redirection therapies. The trial is conducted in an open-label setting and aims to determine the recommended Phase 2 doses of talquetamab. Participants are divided into five cohorts based on their treatment history and prior exposure to T cell redirection therapies. Talquetamab is given subcutaneously, either weekly or biweekly, at doses selected from earlier study parts based on safety and effectiveness data. Some cohorts receive tocilizumab to help prevent cytokine release syndrome. After initial treatment phases, all participants will move into an open-label extension and later a long-term extension phase to continue receiving the study treatment. During the study, participants will be closely monitored for their response to talquetamab over nearly three years. Researchers will assess overall response rate, duration of response, progression-free survival, and safety through adverse event tracking. Quality of life will also be measured with questionnaires. Participants will undergo regular laboratory tests, performance evaluations, and pregnancy testing for women of childbearing potential. The study includes careful safety monitoring and long-term follow-up to evaluate talquetamab's effects.
CONDITIONS
Brief Title
A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of multiple myeloma by international myeloma working group criteria
- Measurable disease by central or local laboratory assessment depending on cohort
- ECOG performance status score of 0 to 2
- Women of childbearing potential must have a negative pregnancy test at screening and before first dose
- Willing and able to follow study restrictions and protocol requirements
You will not qualify if you...
- For Cohorts A and C: prior exposure to CAR-T or T cell redirection therapy at any time
- For Cohorts B, D, and E: T cell redirection therapy within 3 months before study
- Toxicities from prior anticancer therapies must be resolved to baseline or Grade 1 or less, except alopecia or peripheral neuropathy
- Received corticosteroids equivalent to 140 mg or more of prednisone within 14 days before first dose (excluding pretreatment medication)
- Stroke or seizure within 6 months before signing consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Until disease progression
Participants receive Talquetamab injections subcutaneously until their disease progresses. Dosing schedules and additional medications may vary by cohort.
Regular visits for dosing and assessments as per cohort assignment
Follow-up
Duration - Up to 2 years and 10 months
Participants continue to be monitored after treatment ends for safety and response outcomes.
Visits scheduled periodically during follow-up
Trial Site Locations
Total: 78 locations
1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
City of Hope
Duarte, California, United States, 91010
Completed
4
Memorial Healthcare System
Hollywood, Florida, United States, 33021
Actively Recruiting
5
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
7
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Actively Recruiting
8
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
Washington University School Of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
10
NYU Langone Health
New York, New York, United States, 10016
Active, Not Recruiting
11
Mount Sinai Medical Center
New York, New York, United States, 10023
Actively Recruiting
12
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
13
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Completed
14
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Completed
15
UZ Antwerpen
Edegem, Belgium, 2650
Completed
16
UZ Leuven
Leuven, Belgium, 3000
Active, Not Recruiting
17
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium, 4000
Active, Not Recruiting
18
UCL - Saint Luc
Woluwe-Saint-Lambert, Belgium, 1200
Completed
19
Peking University Third Hospital
Beijing, China, 100191
Active, Not Recruiting
20
Sun Yat Sen University Cancer Center
Guangzhou, China, 510060
Active, Not Recruiting
21
The 1st Affiliated Hospital Of Medical College Zhejiang University 1
Hangzhou, China, 310003
Active, Not Recruiting
22
The 1St Affiliated Hospital of Medical College Zhejiang University
Hangzhou, China, 310003
Active, Not Recruiting
23
First Affiliated Hospital SooChow University
Suzhou, China, 215006
Active, Not Recruiting
24
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
Tianjin, China, 300320
Active, Not Recruiting
25
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China, 710004
Completed
26
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China, 710063
Active, Not Recruiting
27
CHU Henri Mondor
Créteil, France, 94000
Active, Not Recruiting
28
Hospices Civils de Lyon HCL
Lyon, France, 69002
Active, Not Recruiting
29
CHU de Montpellier Hopital Saint Eloi
Montpellier, France, 34295
Active, Not Recruiting
30
C.H.U. Hotel Dieu - France
Nantes, France, 44093
Active, Not Recruiting
31
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, France, 33604
Active, Not Recruiting
32
Pôle IUC Oncopole CHU
Toulouse, France, 31059
Active, Not Recruiting
33
Charite Campus Benjamin Franklin
Berlin, Germany, 12203
Active, Not Recruiting
34
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Active, Not Recruiting
35
Universitaetsklinikum Muenster
Münster, Germany, 48149
Completed
36
Universitatsklinikum Wurzburg
Würzburg, Germany, 97080
Active, Not Recruiting
37
Rambam Medical Center
Haifa, Israel, 31096
Active, Not Recruiting
38
Carmel Medical Center
Haifa, Israel, 3436212
Active, Not Recruiting
39
Hadassah Medical Center
Jerusalem, Israel, 91120
Active, Not Recruiting
40
Sheba Medical Center
Ramat Gan, Israel, 52621
Active, Not Recruiting
41
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Active, Not Recruiting
42
Kameda Medical Center
Chiba, Japan, 296-8602
Active, Not Recruiting
43
Fukuoka University Hospital
Fukuoka, Japan, 814-0180
Active, Not Recruiting
44
Ogaki Municipal Hospital
Gifu, Japan, 503-8502
Active, Not Recruiting
45
Teine Keijinkai Hospital
Hokkaido, Japan, 006-8555
Completed
46
Kobe City Medical Center General Hospital
Kobe, Japan, 650 0047
Active, Not Recruiting
47
Dokkyo Medical University Saitama Medical Center
Koshigaya, Japan, 343-8555
Active, Not Recruiting
48
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Active, Not Recruiting
49
Kurashiki Central Hospital
Kurashiki, Japan, 710-8602
Active, Not Recruiting
50
National Hospital Organization Matsumoto Medical Center
Matsumoto, Japan, 399-8701
Active, Not Recruiting
51
National Hospital Organization Okayama Medical Center
Okayama, Japan, 701-1192
Active, Not Recruiting
52
Japanese Red Cross Osaka Hospital
Osaka, Japan, 543 8555
Active, Not Recruiting
53
National Hospital Organization Hiroshima-Nishi Medical Center
Ōtake, Japan, 739-0696
Active, Not Recruiting
54
Iwate Medical University Hospital
Shiwa-gun, Japan, 028-3695
Active, Not Recruiting
55
VU Medisch Centrum
Amsterdam, Netherlands, 1081 HV
Completed
56
UMCU
Utrecht, Netherlands, 3584 CX
Completed
57
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80 214
Active, Not Recruiting
58
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
Gliwice, Poland, 44102
Completed
59
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland, 60-569
Active, Not Recruiting
60
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland, 02-781
Completed
61
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, Poland, 50 367
Active, Not Recruiting
62
Chonnam National University Hwasun Hospital
Jeollanam-do, South Korea, 58128
Completed
63
Seoul National University Hospital
Seoul, South Korea, 03080
Completed
64
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Completed
65
Asan Medical Center
Seoul, South Korea, 05505
Completed
66
Samsung Medical Center
Seoul, South Korea, 06351
Completed
67
The Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea, 06591
Completed
68
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain, 08916
Completed
69
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
70
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, Spain, 8908
Active, Not Recruiting
71
Hosp Univ Fund Jimenez Diaz
Madrid, Spain, 28040
Completed
72
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Active, Not Recruiting
73
Hosp. Univ. Virgen de La Arrixaca
Murcia, Spain, 30120
Active, Not Recruiting
74
Clinica Univ. de Navarra
Pamplona, Spain, 31008
Actively Recruiting
75
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, Spain, 28223
Active, Not Recruiting
76
Hosp Clinico Univ de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
77
Hosp. Univ. Marques de Valdecilla
Santander, Spain, 39008
Actively Recruiting
78
Hosp. Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
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Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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Published Research Related To This Trial
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.
Hermann Einsele, Philippe Moreau, Nizar Bahlis...
https://pubmed.ncbi.nlm.nih.gov/41313549Characterization and Management of Cytokine Release Syndrome From the MonumenTAL-1 Study of Talquetamab in Patients With Relapsed/Refractory Multiple Myeloma.
Niels W C J van de Donk, Ajai Chari, Thomas Martin...
https://pubmed.ncbi.nlm.nih.gov/41036677Infections and parameters of humoral immunity with talquetamab in relapsed/refractory multiple myeloma in MonumenTAL-1.
Carolina Schinke, Paula Rodriguez-Otero, Niels W C J van de Donk...
https://pubmed.ncbi.nlm.nih.gov/40864183Talquetamab 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.
Carolina Schinke, Cyrille Touzeau, Albert Oriol...
https://pubmed.ncbi.nlm.nih.gov/40631904Safety and activity of talquetamab in patients with relapsed or refractory multiple myeloma (MonumenTAL-1): a multicentre, open-label, phase 1-2 study.
Ajai Chari, Cyrille Touzeau, Carolina Schinke...
https://pubmed.ncbi.nlm.nih.gov/40090350Nursing Considerations for the Clinical Management of Adverse Events Associated with Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma.
Donna Catamero, Chloe Ray, Kiah Purcell...
https://pubmed.ncbi.nlm.nih.gov/39155155Comparative Efficacy of Talquetamab vs. Current Treatments in the LocoMMotion and MoMMent Studies in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma.
Hermann Einsele, Philippe Moreau, Nizar Bahlis...
https://pubmed.ncbi.nlm.nih.gov/38402374