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Proteasome Inhibitor

Iberdomide + Daratumumab vs. Bortezomib for Multiple Myeloma (EXCALIBER-RRMM Trial)

Phase 3
Recruiting
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented diagnosis of multiple myeloma (MM) and measurable disease
Must have documented disease progression during or after their last anti-myeloma regimen
Must not have
Known central nervous system involvement with MM
Prior therapy with iberdomide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new combination of drugs to treat multiple myeloma that has come back or is not responding to treatment.

Who is the study for?
This trial is for people with multiple myeloma who've had 1-2 previous treatments but their cancer has gotten worse. They should be fairly active and able to do light work (ECOG score of 0, 1, or 2). It's not for those with certain other blood disorders, brain involvement by myeloma, or anyone previously treated with Iberdomide.
What is being tested?
The study compares two drug combos in patients whose multiple myeloma has returned or didn't respond to treatment: one group gets Iberdomide with Dexamethasone and Daratumumab; the other gets Daratumumab, Bortezomib, and Dexamethasone. The goal is to see which works better.
What are the potential side effects?
Possible side effects include fatigue, infections due to a weakened immune system from the drugs used in both treatments. There may also be specific reactions related to each drug like nerve damage from Bortezomib or blood clots from Iberdomide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with multiple myeloma and it can be measured.
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My myeloma has worsened despite my last treatment.
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I can take care of myself and am up and about more than half of my waking hours.
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I have had 1 or 2 treatments for myeloma before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My multiple myeloma has spread to my brain or spinal cord.
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I have been treated with iberdomide before.
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I have a specific blood disorder such as plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or significant amyloidosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free Survival (PFS)
Secondary study objectives
Duration of Response (DoR)
European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Daratumumab in combination with Iberdomide and dexamethasone - Dose 3Experimental Treatment3 Interventions
Group II: Daratumumab in combination with Iberdomide and dexamethasone - Dose 2Experimental Treatment3 Interventions
Group III: Daratumumab in combination with Iberdomide and dexamethasone - Dose 1Experimental Treatment3 Interventions
Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
Group IV: Daratumumab in combination with dexamethasone and bortezomibActive Control3 Interventions
Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iberdomide
2021
Completed Phase 1
~60
Dexamethasone
2007
Completed Phase 4
~2650
Daratumumab
2014
Completed Phase 3
~2380

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
645 Previous Clinical Trials
129,320 Total Patients Enrolled
146 Trials studying Multiple Myeloma
40,942 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,582 Previous Clinical Trials
3,387,822 Total Patients Enrolled
77 Trials studying Multiple Myeloma
28,255 Patients Enrolled for Multiple Myeloma
April Sorrell, MDStudy DirectorCelgene

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04975997 — Phase 3
Multiple Myeloma Research Study Groups: Daratumumab in combination with Iberdomide and dexamethasone - Dose 2, Daratumumab in combination with Iberdomide and dexamethasone - Dose 3, Daratumumab in combination with dexamethasone and bortezomib, Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT04975997 — Phase 3
Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04975997 — Phase 3
~275 spots leftby Mar 2026
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