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

Phase 3

Active, not recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: Dexamethasone; Drug: Daratumumab; Drug: Bortezomib; Drug: Iberdomide

• Registration Number: NCT04975997
• Lead Sponsor: Celgene

Brief 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).

Detailed Description

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). Approximately 200 patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6 mg in combination with daratumumab and dexamethasone (Treatment Arms A1, A2, or A3), or to the DVd comparator arm (Treatment Arm B).

In Stage 2 of the study, approximately 664 additional subjects will be randomized 1:1 between 2 treatment arms:

* Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd)

* Approximately 332 subjects will be randomized to receive Treatment Arm B (DVd)

Participants in both treatment arms will continue to receive treatment until confirmed progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (PFS), participants who permanently discontinue study treatment for any reason, other than confirmed PD or withdrawal of consent, will continue to be followed for disease assessment.

The study will be conducted in compliance with International Council for Harmonisation (ICH) and Good Clinical Practices (GCPs).

Study Timeline

• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-26
• Study Start: 2022-06-23
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-10
• Primary Completion: 2026-03-18
• Study Completion: 2032-06-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 864

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1	Dexamethasone	Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1	Daratumumab	Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1	Iberdomide	Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2	Daratumumab	-
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2	Iberdomide	-
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2	Dexamethasone	-
Daratumumab in combination with Iberdomide and dexamethasone - Dose 3	Dexamethasone	-
Daratumumab in combination with Iberdomide and dexamethasone - Dose 3	Daratumumab	-
Daratumumab in combination with Iberdomide and dexamethasone - Dose 3	Iberdomide	-
Daratumumab in combination with dexamethasone and bortezomib	Dexamethasone	Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
Daratumumab in combination with dexamethasone and bortezomib	Bortezomib	Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
Daratumumab in combination with dexamethasone and bortezomib	Daratumumab	Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to approximately 5 years	To evaluate clinical efficacy in terms of overall survival (OS) in participants with relapsed or refractory multiple myeloma (RRMM) treated with iberdomide, daratumumab, and dexamethasone (IberDd) compared to daratumumab, bortezomib, and dexamethasone (DVd).
Sustainability of Minimal Residual Disease (MRD) negativity	Up to approximately 5 years	To evaluate the sustainability of minimal residual disease (MRD) negativity.
Overall Response Rate (ORR)	Up to approximately 5 years	Calculated as percentage of participants who achieve best response of partial response (PR) or better according to the IMWG Uniform Response Criteria for multiple myeloma.
Time to response (TTR)	Up to approximately 5 years	Time from randomization to the first documentation of response (PR or better).
Duration of Response (DoR)	Up to approximately 5 years	Time from the first documentation of response (PR or better) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first.
Time to Progression (TTP)	Up to approximately 5 years	The time from randomization to the first documented disease progression.
Progression-free Survival 2 (PFS2)	Up to approximately 5 years	Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first.
Safety	Up to approximately 5 years	Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment.
European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)	Up to approximately 5 years	Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ-C30.
European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)	Up to approximately 5 years	EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ- MY20.
Recommended iberdomide dose for Stage 2	Up to approximately 1 year
Area under the plasma concentration-time curve from time zero to tau (AUC(TAU))	Up to approximately 1 year
Maximum plasma concentration (Cmax)	Up to approximately 1 year
Time to maximum plasma concentration (Tmax)	Up to approximately 1 year
Time to Next Treatment (TTNT)	Up to approximately 5 years	Time from randomization to the start of the next antimyeloma treatment.

Trial Locations

Locations (259)

Local Institution - 035; 🇺🇸 Hot Springs, Arkansas, United States

Local Institution - 641; 🇺🇸 Cerritos, California, United States

Local Institution - 681; 🇺🇸 Fountain Valley, California, United States

Local Institution - 047; 🇺🇸 Los Angeles, California, United States

Local Institution - 684; 🇺🇸 Newport, California, United States

Local Institution - 033; 🇺🇸 New Haven, Connecticut, United States

Local Institution - 029; 🇺🇸 Fort Myers, Florida, United States

Local Institution - 693; 🇺🇸 Ocala, Florida, United States

Local Institution - 028; 🇺🇸 Saint Petersburg, Florida, United States

Local Institution - 045; 🇺🇸 Tamarac, Florida, United States

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