Multiple Myeloma Clinical Trial

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

Summary

The purpose of this study is to evaluate the efficacy of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

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Full Description

Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions, increased susceptibility to infections, hypercalcemia, and renal failure. Talquetamab is a humanized immunoglobulin G4 proline, alanine, alanine (IgG4PAA) bispecific antibody designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the CD3 molecule found on T lymphocytes (T cell). This study consists 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment [EOT (30 days (+ 7 days)] visit); and a post-treatment follow-up phase (until the end of study unless the participant has died, is lost to follow up or has withdrawn consent). Total duration of study is up to 2 years (after the last participant receives their first dose). Safety, pharmacokinetics (PK), laboratory tests, and questionnaire will be assessed at specified time points during this study. Participants safety and study conduct will be monitored throughout the study. The corresponding study (NCT03399799) is the Phase 1 part of the study and TALMMY1001- Part 3 is the Phase 2 part of the study.

View Eligibility Criteria

Eligibility Criteria

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, and cohort C: multiple myeloma must be measurable by central 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: T cell redirection therapy within 3 months
Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of talquetamab
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)

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

320

Study ID:

NCT04634552

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 84 Locations for this study

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University of Alabama Birmingham
Birmingham Alabama, 35294, United States
The University of Arizona Cancer Center
Tucson Arizona, 85719, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
City of Hope
Duarte California, 91010, 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
Saint 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
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus Ohio, 43210, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
UCL - Saint Luc
Brussels , 1200, Belgium
UZ Antwerpen
Edegem , 2650, Belgium
UZ Leuven
Leuven , 3000, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège , 4000, Belgium
Peking University Third Hospital
Beijing , 10019, China
Second Affiliated Hospital of Army Medical University
Chongqing , 40003, China
Sun Yat-Sen University Cancer Center
Guangzhou , 51006, China
First affiliated Hospital of Zhejiang University
Hangzhou , 31000, China
First Affiliated Hospital, SooChow University
Su Zhou , 21500, China
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
Tianjin , 30032, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an , 71000, China
First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
Xi'an , 71006, China
CHU Henri Mondor
Creteil , 94000, 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 cedex , 33604, France
Centre hospitalier Lyon-Sud
Pierre Benite cedex , 69495, France
Pôle IUC Oncopole CHU
Toulouse cedex 9 , 31059, France
Charite Campus Benjamin Franklin
Berlin , 12203, Germany
Universitatsklinikum Freiburg
Freiburg , 79106, Germany
Medizinische Hochschule Hannover
Hannover , 30625, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitaetsklinikum Muenster
Muenster , 48149, Germany
Klinikum Großhadern der Ludwig-Maximilians-Universität
München , 81377, Germany
Universitätsklinikum Würzburg
Würzburg , 97080, Germany
Rambam Medical Center
Haifa , 31096, Israel
Carmel Medical Center
Haifa , 34362, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Kameda General Hospital
Chiba , 296-8, Japan
Fukuoka University Hospital
Fukuoka , 814-0, Japan
Ogaki Municipal Hospital
Gifu , 503-8, Japan
Kobe City Medical Center General Hospital
Hyogo , 650-0, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya , 343-8, Japan
Kumamoto University Hospital
Kumamoto , 860-8, Japan
Kurashiki Central Hospital
Kurashiki , 710-8, Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto , 399-8, Japan
Nagoya City University Hospital
Nagoya , 467-8, Japan
National Hospital Organization Okayama Medical Center
Okayama , 701-1, Japan
Japanese Red Cross Osaka Hospital
Osaka , 543-8, Japan
Iwate Medical University Hospital
Shiwa-gun , 028-3, Japan
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
VU Medisch Centrum
Amsterdam , 1081 , Netherlands
UMCU
Utrecht , 3584 , Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-21, Poland
Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach
Gliwice , 44102, Poland
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin , 20090, Poland
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Po
Poznan , 60-56, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw , 50-36, Poland
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 Alarcon , 28223, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Univ. Marques de Valdecilla
Santander , 39008, Spain
Hosp. Virgen Del Rocio
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

320

Study ID:

NCT04634552

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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