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

Summary:

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

• 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)

View this trial on ClinicalTrials.gov