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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1 		Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
  • Drug: Dexamethasone
    Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
  • Drug: 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
    Other names:
    • DARZALEX FASPRO
  • Drug: Iberdomide
    Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle
    Other names:
    • CC-220
    • BMS-986382
Experimental
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
  • Drug: Dexamethasone
    Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
  • Drug: 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
    Other names:
    • DARZALEX FASPRO
  • Drug: Iberdomide
    Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle
    Other names:
    • CC-220
    • BMS-986382
Experimental
Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
  • Drug: Dexamethasone
    Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
  • Drug: 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
    Other names:
    • DARZALEX FASPRO
  • Drug: Iberdomide
    Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle
    Other names:
    • CC-220
    • BMS-986382
Active Comparator
Daratumumab in combination with dexamethasone and bortezomib 		Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
  • Drug: Dexamethasone
    Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
  • Drug: 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
    Other names:
    • DARZALEX FASPRO
  • Drug: 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.

Recruiting Locations

MetroHealth Medical Center - Main Campus
Cleveland, Ohio 44109
Contact:
Tamila Kindwall-Keller, Site 037
216-778-7800

More Details

Status
Recruiting
Sponsor
Celgene

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.