Medical College of Wisconsin
This is a single-arm, open-label, phase 1b study evaluating the safety and feasibility of using talquetamab as bridging therapy prior to cilta-cel in patients with relapsed and refractory multiple myeloma (RRMM).
This study will enroll patients with RRMM who have received at least one prior line of therapy and are eligible for both commercial talquetamab and cilta-cel. Patients will enroll prior to apheresis. Following apheresis, patients will receive one cycle of talquetamab therapy. An additional cycle of talquetamab will be allowed if manufacturing delays result in an expected lymphodepletion date \> 4 weeks from the last full dose of talquetamab in Cycle 1. Following successful manufacturing, patients will receive lymphodepleting chemotherapy and cilta-cel infusion.
Inclusion Criteria: 1. Age \> 18 years. 2. Histologically confirmed diagnosis of multiple myeloma with evidence of progressive disease as defined by the IMWG criteria. 3. Have measurable disease, defined as: 1. Serum M-protein level ≥ 1.0 g/dL, or 2. Urine M-protein level ≥ 200 mg/24 hours, or 3. In patients without a measurable M-protein, an involved light chain level ≥ 10 mg/dL and an abnormal free light chain ratio. 4. Patient had at least one prior line of therapy (PLOT), including a proteasome inhibitor (PI), an anti-CD38 antibody, and an immunomodulatory drug (IMID). 5. Patien…
Talquetamab will be administered subcutaneously.
Ciltacabtagene Autoleucel will be administered intravenously.
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