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Purpose

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

Condition

Eligibility

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

Inclusion Criteria

  • Confirmed diagnosis of symptomatic multiple myeloma (MM). - Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2. - Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, daratumumab + bortezomib/thalidomide/dexamethasone [D-VTd] and daratumumab + bortezomib/ lenalidomide/dexamethasone [D-VRd]), or VCd / daratumumab + bortezomib/cyclophosphamide/dexamethasone [D-VCd], and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted. - Participants within 12 months (single transplant) or 15 months (tandem transplant) from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria.

Exclusion Criteria

  • Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy. - Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma. - Known central nervous system/meningeal involvement of MM. - Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years. - 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
Arm A1: Iberdomide Dose 1
  • Drug: Iberdomide
    Specified dose on specified days
    Other names:
    • CC-220
    • BMS-986382
Experimental
Arm A2: Iberdomide Dose 2
  • Drug: Iberdomide
    Specified dose on specified days
    Other names:
    • CC-220
    • BMS-986382
Experimental
Arm A3: Iberdomide Dose 3
  • Drug: Iberdomide
    Specified dose on specified days
    Other names:
    • CC-220
    • BMS-986382
Active Comparator
Arm B: Lenalidomide
  • Drug: Lenalidomide
    Specified dose on specified days
    Other names:
    • Revlimid®

Recruiting Locations

UMass Memorial Medical Center
Worcester, Massachusetts 01655
Contact:
Muthalagu Ramanathan, Site 0279
774-442-3903

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

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

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.