Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

NCT04975997 · tracked via the Priya Life Science UK tracker

Sponsor

Celgene

Phase

Phase 3

Started

2022-06-23

Last updated

2026-04-03

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

DexamethasoneDaratumumabBortezomibIberdomideIberdomideIberdomideDexamethasoneDaratumumab

Dexamethasone: Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle

Daratumumab: Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7+ of a 28-day cycle

Bortezomib: Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.

Iberdomide: Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle

Iberdomide: Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle

Iberdomide: Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle

Dexamethasone: Oral dexamethasone 20mg on days 1,2, 4,5,8,9,11,12 of a 21-day cycle from cycles 1-8

Daratumumab: Subcutaneous daratumumab 1800mg Cycles 1 to 3 on Days 1, 8, 15 of a 21-day cycle, Cycles 4 to 8 on Day 1 of a 21-day cycle and Cycles 9+ on Day 1 of a 28-day cycle.

Study summary

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria * 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 Criteria * 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.

Primary outcome measure(s)

Progression-free Survival (PFS) — Up to approximately 5 years
To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of progression free survival (PFS).
Minimal Residual Disease (MRD) negative Complete Response (CR) at any time — Up to approximately 5 years
To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of minimal residual disease (MRD) negative complete response (CR) at any time.

Trial sites (259)

Facility	City	Region
Local Institution - 035	Hot Springs	Arkansas
Local Institution - 641	Cerritos	California
Local Institution - 681	Fountain Valley	California
Local Institution - 047	Los Angeles	California
Local Institution - 684	Newport	California
Local Institution - 033	New Haven	Connecticut
Local Institution - 029	Fort Myers	Florida
Local Institution - 693	Ocala	Florida
Local Institution - 028	St. Petersburg	Florida
Local Institution - 045	Tamarac	Florida
Local Institution - 034	West Palm Beach	Florida
Local Institution - 685	Weston	Florida
Local Institution - 018	Atlanta	Georgia
Local Institution - 640	Elk Grove Village	Illinois
Local Institution - 697	Dyer	Indiana
Local Institution - 040	Louisville	Kentucky
Local Institution - 041	Alexandria	Louisiana
Local Institution - 682	Baton Rouge	Louisiana
Local Institution - 027	Baton Rouge	Louisiana
Local Institution - 698	Baltimore	Maryland
Local Institution - 014	Bethesda	Maryland
Local Institution - 688	Columbia	Maryland
Local Institution - 010	Boston	Massachusetts
Local Institution - 009	Worcester	Massachusetts
Local Institution - 645	Burnsville	Minnesota
Local Institution - 031	Kansas City	Missouri
Local Institution - 046	Billings	Montana
Local Institution - 015	Summit	New Jersey
Local Institution - 691	New York	New York
Local Institution - 039	Durham	North Carolina
Local Institution - 038	Cincinnati	Ohio
Local Institution - 037	Cleveland	Ohio
Local Institution - 008	Cleveland	Ohio
Local Institution - 036	Columbus	Ohio
Local Institution - 680	Tulsa	Oklahoma
Local Institution - 043	Portland	Oregon
Local Institution - 030	Chattanooga	Tennessee
Local Institution - 021	Nashville	Tennessee
Local Institution - 687	Austin	Texas
Local Institution - 695	Houston	Texas

+ 219 more sites — see the full list on the official registry below.

On this site

📄 Darzalex (daratumumab) drug profile →

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A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04975997 on ClinicalTrials.gov ↗ ← All trials in the UK