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).
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04634552 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Janssen Research & Development, LLC |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Janssen Research & Development, LLC Clinical Trial |
Principal Investigator Affiliation | Janssen Research & Development, LLC |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Belgium, China, France, Germany, Israel, Japan, Korea, Republic of, Netherlands, Poland, Spain, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Hematological Malignancies |
Study Website: | View Trial Website |
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 of 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Drug: - Talquetamab
Talquetamab will be administered SC until disease progression.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University of Alabama Birmingham
Birmingham, Alabama, 35294
Status
Recruiting
Address
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Status
Completed
Address
City of Hope
Duarte, California, 91010
Status
Recruiting
Address
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322
Status
Recruiting
Address
University of Chicago
Chicago, Illinois, 60637
Status
Recruiting
Address
Norton Cancer Institute
Louisville, Kentucky, 40207
Status
Recruiting
Address
University of Michigan Health System
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Recruiting
Address
NYU Langone Health
New York, New York, 10016
Status
Recruiting
Address
Mount Sinai Medical Center
New York, New York, 10023
Status
Recruiting
Address
University of Rochester Medical Center
Rochester, New York, 14642
Status
Recruiting
Address
Providence Portland Medical Center
Portland, Oregon, 97213
Status
Recruiting
Address
Tennessee Oncology
Nashville, Tennessee, 37203
Status
Recruiting
Address
UCL - Saint Luc
Brussels, , 1200
Status
Recruiting
Address
UZ Antwerpen
Edegem, , 2650
Status
Recruiting
Address
UZ Leuven
Leuven, , 3000
Status
Recruiting
Address
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, , 4000
Status
Recruiting
Address
Peking University Third Hospital
Beijing, , 100191
Status
Recruiting
Address
Sun Yat-Sen University Cancer Center
Guangzhou, , 510060
Status
Active, not recruiting
Address
The 1St Affiliated Hospital of Medical College Zhejiang University
Hangzhou, , 310003
Status
Recruiting
Address
The 1St Affiliated Hospital of Medical College Zhejiang University
Hangzhou, , 310003
Status
Recruiting
Address
First Affiliated Hospital SooChow University
Su Zhou, , 215006
Status
Recruiting
Address
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
Tianjin, , 300320
Status
Recruiting
Address
The First Affiliated Hospital of Xian Jiaotong University
XI An Shi, , 710063
Status
Completed
Address
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , 710004
Status
Recruiting
Address
CHU Henri Mondor
Creteil, , 94000
Status
Recruiting
Address
CHU de Montpellier, Hopital Saint-Eloi
Montpellier, , 34295
Status
Recruiting
Address
C.H.U. Hotel Dieu - France
Nantes, , 44093
Status
Recruiting
Address
CHU de Bordeaux - Hospital Haut-Leveque
Pessac cedex, , 33604
Status
Recruiting
Address
Centre hospitalier Lyon-Sud
Pierre Benite cedex, , 69495
Status
Recruiting
Address
Pôle IUC Oncopole CHU
Toulouse cedex 9, , 31059
Status
Recruiting
Address
Charite Campus Benjamin Franklin
Berlin, , 12203
Status
Recruiting
Address
Universitaetsklinikum Heidelberg
Heidelberg, , 69120
Status
Completed
Address
Universitaetsklinikum Muenster
Muenster, , 48149
Status
Recruiting
Address
Universitatsklinikum Wurzburg
Wuerzburg, , 97080
Status
Recruiting
Address
Rambam Medical Center
Haifa, , 31096
Status
Recruiting
Address
Carmel Medical Center
Haifa, , 3436212
Status
Recruiting
Address
Hadassah Medical Center
Jerusalem, , 91120
Status
Recruiting
Address
Sheba Medical Center
Ramat Gan, , 52621
Status
Recruiting
Address
Tel Aviv Sourasky Medical Center
Tel Aviv, , 64239
Status
Active, not recruiting
Address
Kameda General Hospital
Chiba, , 296-8602
Status
Active, not recruiting
Address
Fukuoka University Hospital
Fukuoka, , 814-0180
Status
Active, not recruiting
Address
Ogaki Municipal Hospital
Gifu, , 503-8502
Status
Active, not recruiting
Address
Teine Keijinkai Hospital
Hokkaido, , 006-8555
Status
Active, not recruiting
Address
Kobe City Medical Center General Hospital
Hyogo, , 650-0047
Status
Active, not recruiting
Address
Dokkyo Medical University Saitama Medical Center
Koshigaya, , 343-8555
Status
Active, not recruiting
Address
Kumamoto University Hospital
Kumamoto, , 860-8556
Status
Active, not recruiting
Address
Kurashiki Central Hospital
Kurashiki, , 710-8602
Status
Active, not recruiting
Address
National Hospital Organization Matsumoto Medical Center
Matsumoto, , 399-8701
Status
Active, not recruiting
Address
National Hospital Organization Okayama Medical Center
Okayama, , 701-1192
Status
Active, not recruiting
Address
Japanese Red Cross Osaka Hospital
Osaka, , 543-8555
Status
Active, not recruiting
Address
Hiroshima West Medical Center
Otake, , 739-0696
Status
Active, not recruiting
Address
Iwate Medical University Hospital
Shiwa-gun, , 028-3695
Status
Recruiting
Address
Chonnam National University Hwasun Hospital
Jeollanam-do, , 58128
Status
Recruiting
Address
Seoul National University Hospital
Seoul, , 03080
Status
Completed
Address
Severance Hospital, Yonsei University Health System
Seoul, , 03722
Status
Completed
Address
Asan Medical Center
Seoul, , 05505
Status
Completed
Address
Samsung Medical Center
Seoul, , 06351
Status
Recruiting
Address
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , 06591
Status
Recruiting
Address
VU Medisch Centrum
Amsterdam, , 1081 HV
Status
Completed
Address
UMCU
Utrecht, , 3584 CX
Status
Active, not recruiting
Address
Uniwersyteckie Centrum Kliniczne
Gdansk, , 80-214
Status
Completed
Address
Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach
Gliwice, , 44102
Status
Active, not recruiting
Address
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , 60-569
Status
Active, not recruiting
Address
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warszawa, , 02-781
Status
Active, not recruiting
Address
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, , 52-007
Status
Recruiting
Address
Hosp. Univ. Germans Trias I Pujol
Badalona, , 08916
Status
Recruiting
Address
Hosp. Univ. Vall D Hebron
Barcelona, , 08035
Status
Recruiting
Address
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, , 8908
Status
Completed
Address
Hosp. Univ. Fund. Jimenez Diaz
Madrid, , 28040
Status
Recruiting
Address
Hosp. Univ. 12 de Octubre
Madrid, , 28041
Status
Recruiting
Address
Hosp. Univ. Virgen de La Arrixaca
Murcia, , 30120
Status
Recruiting
Address
Clinica Univ. de Navarra
Pamplona, , 31008
Status
Recruiting
Address
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcon, , 28223
Status
Recruiting
Address
Hosp. Clinico Univ. de Salamanca
Salamanca, , 37007
Status
Recruiting
Address
Hosp. Univ. Marques de Valdecilla
Santander, , 39008
Status
Recruiting
Address
Hosp. Virgen Del Rocio
Sevilla, , 41013