A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Trial ID or NCT#
NCT04634552
Status
RECRUITING
Purpose
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).
Official Title
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
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; 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
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, 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)
Investigator(s)
Surbhi Sidana, MD
Blood and marrow transplant specialist,
Hematologist-Oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Contact us to find out if this trial is right for you.
Contact
Kelly Chyan
650-625-8130
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