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).
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 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a post-treatment follow-up phase (until the end of study unless the participant has died, is lost to follow up or has withdrawn consent).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.
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, cohort C, and cohort D: 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 and Cohort D: 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)
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There are 76 Locations for this study
Birmingham Alabama, 35294, United States
Little Rock Arkansas, 72205, United States
Duarte California, 91010, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60637, United States
Louisville Kentucky, 40207, United States
Ann Arbor Michigan, 48109, United States
Saint Louis Missouri, 63110, United States
New York New York, 10016, United States
New York New York, 10023, United States
Rochester New York, 14642, United States
Portland Oregon, 97213, United States
Nashville Tennessee, 37203, United States
Brussels , 1200, Belgium
Edegem , 2650, Belgium
Leuven , 3000, Belgium
Liège , 4000, Belgium
Beijing , 10019, China
Guangzhou , 51006, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Su Zhou , 21500, China
Tianjin , 30032, China
XI An Shi , 71006, China
Xi'an , 71000, China
Creteil , 94000, France
Montpellier , 34295, France
Nantes , 44093, France
Pessac cedex , 33604, France
Pierre Benite cedex , 69495, France
Toulouse cedex 9 , 31059, France
Berlin , 12203, Germany
Heidelberg , 69120, Germany
Muenster , 48149, Germany
Wuerzburg , 97080, Germany
Haifa , 31096, Israel
Haifa , 34362, Israel
Jerusalem , 91120, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Chiba , 296-8, Japan
Fukuoka , 814-0, Japan
Gifu , 503-8, Japan
Hokkaido , 006-8, Japan
Hyogo , 650-0, Japan
Koshigaya , 343-8, Japan
Kumamoto , 860-8, Japan
Kurashiki , 710-8, Japan
Matsumoto , 399-8, Japan
Okayama , 701-1, Japan
Osaka , 543-8, Japan
Otake , 739-0, Japan
Shiwa-gun , 028-3, Japan
Jeollanam-do , 58128, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Amsterdam , 1081 , Netherlands
Utrecht , 3584 , Netherlands
Gdansk , 80-21, Poland
Gliwice , 44102, Poland
Poznan , 60-56, Poland
Warszawa , 02-78, Poland
Wroclaw , 52-00, Poland
Badalona , 08916, Spain
Barcelona , 08035, Spain
Barcelona , 8908, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Murcia , 30120, Spain
Pamplona , 31008, Spain
Pozuelo de Alarcon , 28223, Spain
Salamanca , 37007, Spain
Santander , 39008, Spain
Sevilla , 41013, Spain
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