Cevostamab Following CAR T Cell Therapy for RRMM

Relapsed/Refractory Multiple Myeloma Clinical Trial

Official title: Phase 2 Study of Cevostamab Consolidation Following BCMA CAR T Cell Therapy for Relapsed/Refractory Multiple Myeloma

Status Recruiting

Clinical Trial Summary

This is a Phase 2, open-label, single-arm, single stage, single-institution study, with an initial safety run-in period. Potential participants with relapsed/refractory myeloma who are undergoing standard of care, commercially-available BCMA-directed CAR T cell therapy may be identified pre-CAR T cell infusion but are not consented and enrolled until at least 4-6 weeks after CAR T cell infusion, once recovered from acute toxicities. Note: the lymphodepleting chemotherapy and CAR T cell therapy is being administered as part of standard clinical practice and is not considered part of this protocol. Alternative lymphodepleting regimens other than fludarabine and cyclophosphamide (eg in the setting of fludarabine shortages) are acceptable. Cevostamab will be given as an IV infusion once every 3 weeks, starting roughly 10 weeks (day 70 +/- 4 days) post-CAR T cell infusion, with subjects planned to receive 8 cycles initially. Aiming to assess the impact of cevostamab consolidation post-BCMA CAR T cell therapy on rate of MRD-negative complete remission (CR) at 12 months.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed/Refractory Multiple Myeloma

• NCT number: NCT05801939
• Study type: Interventional
• Source: University of Pennsylvania
• Status: Recruiting
• Phase: Phase 2
• Start date: July 11, 2023
• Completion date: May 2028