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A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM) (EXCALIBER-RRMM)

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Trial Profile

A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM) (EXCALIBER-RRMM)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Apr 2026

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At a glance

Most Recent Events

  • 03 Apr 2026 Planned primary completion date changed from 18 Mar 2026 to 16 Nov 2027.
  • 17 Feb 2026 According to Bristol Myers Squibb media release, based on results from a planned analysis of MRD negativity rates from this trial the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for iberdomide combined with standard treatment in patients with relapsed or refractory multiple myeloma (RRMM).The FDA has granted a Prescription Drug User Fee Act (PDUFA) date of August 17, 2026 for this indication.
  • 23 Sep 2025 According to Bristol Myers Squibb media release, the company plans to discuss these results with health authorities.

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