Dose-Escalation Study of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)

Official Title

An Open-Label, Multicentre, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of Cevostamab (BFCR4350A) in Patients With Relapsed or Refractory Multiple Myeloma


This is a phase I, multicentre, open-label, dose-escalation study of cevostamab administered as a single agent by IV infusion to participants with relapsed or refractory multiple myeloma (R/R MM).

Trial Description

Primary Outcome:

  • Percentage of Participants with Adverse Events (AEs)
  • Percentage of Participants With Dose-Limiting Toxicities (DLTs)
  • Arm E Only: Incidence and Severity of Cytokine-release Syndrome (CRS) Following Tocilizumab Premedication Followed by Treatment with Cevostamab
Secondary Outcome:
  • Area Under the Concentration-Time Curve
  • Cmax
  • Minimum observed serum concentration (Cmin)
  • Clearance (CL)
  • Volume of Distribution at Steady State (Vdss)
  • Objective Response Rate (ORR)
  • Duration of Response
  • Change from Baseline in the Presence Anti-Drug Antibodies (ADAs)

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Canadian Cancer Society

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