A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma

ConditionMultiple Myeloma

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorGenentech, Inc.

About this trial

This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab plus pomalidomide and dexamethasone (Pd) or cevostamab plus daratumumab and dexamethasone (Dd) which will be administered to participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Life expectancy of at least 12 weeks

Agreement to provide bone marrow biopsy and aspirate samples

Resolution of adverse events from prior anti-cancer therapy to Grade <=1

Disqualifiers

Prior treatment with cevostamab or another agent targeting FcRH5

Inability to comply with protocol-mandated hospitalization and activities restrictions

Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the last dose of cevostamab or within 3 months after the last dose of tocilizumab (if applicable).

Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drugconjugate as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy

Trial design

Design model

Parallel

Treatments tested in this trial

Cevostamab
Drug
Cevostamab will be administered intravenously on a 28-day cycle, up to a total of 13 cycles (Arm A), in 28-day cycles Q2W followed by Q4W (Arm B) and in 21 day cycles from C1-C8 Q3W and 28-day cycles from C9 onwards Q4W (Arm C). For Arm A, participants have the option to enter re-treatment within 12 months of the end of treatment visit. For Arms B and C, participants can be treated until disease progression or unacceptable toxicity.
Tocilizumab
Drug
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
Pomalidomide
Drug
Pomalidomide will be administered orally (PO) on a 28-day cycle.
Daratumumab
Drug
Daratumumab will be administered subcutaneously (SC) on 21 day (C1-8) and 28-day cycles (C9 onwards).
Dexamethasone
Drug
Arm A: Dexamethasone will be administered as a premedication. Arms B and C: Dexamethasone will be administered via IV or orally at 20 mg as study investigational medicinal product.

Treatment groups

186 Participants

are divided into 3 treatment groups

Group A: Single-Agent Cevostamab (Arm A)Experimental treatment 3 interventions

Group B: Cevostamab plus Pomalidomide and Dexamethasone (Pd) (Arm B)Experimental treatment 4 interventions

Group C: Cevostamab plus Daratumumab and Dexamethasone (Dd) (Arm C)Experimental treatment 4 interventions