Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Trial acronym
EXCALIBER-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 people with relapsed or refractory multiple myeloma
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 have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
- 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)
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