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

Titre officiel

An Open-Label, Multicentre, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Patients With Relapsed or Refractory Multiple Myeloma

Sommaire:

This Phase Ib, multicentre, 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.

Description de l'essai

Primary Outcome:

• Percentage of Participants with Adverse Events

• Objective Response Rate (ORR)
• Complete Response/Stringent Complete Response (CR/sCR) Rate
• Rate of Very Good Partial Response (VGPR) or Better
• Progression-free Survival (PFS)
• Duration of Response (DOR)
• Time to First Response (for Participants who Achieve a Response of Partial Response (PR) or Better)
• Time to Best Response (for Participants who Achieve a Response of PR or Better)
• Minimal Residual Disease (MRD) Negativity
• Overall Survival (OS)
• Serum Concentration of Cevostamab at Specified Timepoints
• Total Exposure (Area Under the Concentration-time Curve [AUC]) of Cevostamab
• Maximum Observed Serum Concentration (Cmax) of Cevostamab
• Minimum Observed Serum Concentration (Cmin) of Cevostamab
• Clearance of Cevostamab
• Volume of Distribution at Steady State of Cevostamab
• Number of Anti-drug Antibody (ADAs) Against Cevostamab at Baseline
• Percentage of Participants with ADAs Against Cevostamab During the Study
• Serum Concentration of Pomalidomide
• Serum Concentration of Daratumumab

Voir cet essai sur ClinicalTrials.gov