Talquetamab

Talquetamab will be administered subcutaneously.

Ciltacabtagene Autoleucel will be administered intravenously.

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.

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).

Registro actualizado en ClinicalTrials.gov →

• Histologically confirmed diagnosis of multiple myeloma with evidence of progressive disease as defined by the IMWG criteria.
• Have measurable disease, defined as:
• Serum M-protein level ≥ 1.0 g/dL, or
• Urine M-protein level ≥ 200 mg/24 hours, or
• In patients without a measurable M-protein, an involved light chain level ≥ 10 mg/dL and an abnormal free light chain ratio.
• Patient had at least one prior line of therapy (PLOT), including a proteasome inhibitor (PI), an anti-CD38 antibody, and an immunomodulatory drug (IMID).

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.