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Active Not Recruiting NCT06550895

A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

Conditions: Multiple Myeloma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 11
Sponsor: Janssen Research & Development, LLC

Location: University of Iowa Hospital and Clinics Iowa City Iowa

Summary

The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).

Eligibility Criteria

Inclusion Criteria: * Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening * Cohort 1: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (\>=) 1 complete cycle of the therapy * Cohort 1: Documented evidence of progression of disease (PD) or failure to achieve a response to the last line of therapy * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Participant of childbearing potential (POCBP) must have a negative pregnancy test using a highly sensitive β-human chorionic gonadotropin (hCG) serum pregnancy test at screening Exclusion Criteria: * Cohort 1: Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy directed at any target or any prior B cell maturation antigen (BCMA)-directed therapy/prior G protein-coupled receptor family C Group 5 member D (GPRC5D)-directed therapy * Cohort 1: Received either of the following: An allogenic stem cell transplant within 6 months before apheresis/first dose of study drug and no immunosuppressive medications administered before the start of study treatment. And secondly, received an autologous stem cell transplant less than (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06550895). StuddyBuddy aggregates publicly available trial information.