Cevostamab Following CAR T Cell Therapy for RRMM

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 11, 2023

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2028

Conditions
Relapsed/Refractory Multiple Myeloma
Interventions
DRUG

Cevostamab

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. Subjects receive a single step-up dose of 3.6 mg of cevostamab on cycle 1, day 1 (C1D1), followed by the recommended target dose (160 mg, 132mg, or 90 mg based on results of safety run-in data and safety review) on C1D8. Myeloma responses are assessed every cycle, and a repeat bone marrow aspirate and biopsy (BMbx) is performed at the start of cycle 8. If participants are not in an MRD-negative CR at this timepoint (or if the BM bx is inevaluable/indeterminate for CR or MRD testing), they continue with another 8 cycles (C9-16) of cevostamab. If they are in MRD-negative CR at start of C8, they stop therapy after receiving this cycle and are observed.

Trial Locations (1)

19104

RECRUITING

Hospital of the University of Pennsylvania, Philadelphia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

University of Pennsylvania

OTHER