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

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

Treatments tested in this trial

  • Cevostamab
  • Tocilizumab
  • Pomalidomide
  • Daratumumab
  • Dexamethasone

Treatment groups

186 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Genentech, Inc.

Lead sponsor

Hoffmann-La Roche

Collaborator