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RecruitingLast updated: 4 April 2024

EXCALIBER-RRMM: This study is comparing the safety and effectiveness of two different drug combinations in people with relapsed or refractory multiple myelomaA 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)

Clinical summary

Summary

This study has two stages.

In Stage One, participants will be randomly allocated to one of four treatment arms:

  • Arm A1 will receive iberdomide in combination with daratumumab and dexamethasone (IberDd). In this arm, Iberdomide will be given at a dose of 1mg.
  • Arm A2 will receive IderDd, where Ibderdomide will be given at a dose of 1.3mg.
  • Arm A3 will receive IberDd, where Iberdomide will be given at a dose of 1.6mg.
  • Arm B will receive daratumumab, bortezomib and dexamethasone (DVd).

 

In Stage Two, additional participants will be randomly allocated to one of two treatment arms:

  • Treatment Arm A will receive IberDd
  • Treatment Arm B will receive DVd

Dexamethasone and Iberdomide will be administered orally, while Daratumumanb and Bortezomib will be given as a subcutaneous injections.

Conditions

This trial is treating patients with relapsed or refractory multiple myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

EXCALIBER-RRMM

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT04975997
  • CC-220-MM-002; U1111-1260-2872; 2020-000431-49

Trial sponsor

Celgene

Scientific Title

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)

Eligibility

Inclusion

  • Documented diagnosis of multiple myeloma (MM) and measurable disease
  • Received 1 to 2 prior lines of anti-myeloma therapy
  • Must have documented disease progression during or after their last anti-myeloma regimen
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2

Exclusion

  • Any condition that confounds the ability to interpret data from the study
  • Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis
  • Known central nervous system involvement with MM
  • Prior therapy with iberdomide

Other protocol-defined inclusion/exclusion criteria apply

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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