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A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
Phase 3

Conditions

Multiple Myeloma

Treatments

Drug: Lenalidomide
Drug: Iberdomide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05827016
IM048-022
2022-501515-14 (EudraCT Number)
U1111-1280-9492 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment

1,216 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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, or Velcade® (bortezomib), cyclophosphamide, dexamethasone (VCd), and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.
  • Participants within 12 months 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,216 participants in 4 patient groups

Arm A1: Iberdomide Dose 1
Experimental group
Treatment:
Drug: Iberdomide
Arm A2: Iberdomide Dose 2
Experimental group
Treatment:
Drug: Iberdomide
Arm A3: Iberdomide Dose 3
Experimental group
Treatment:
Drug: Iberdomide
Arm B: Lenalidomide
Active Comparator group
Treatment:
Drug: Lenalidomide

Trial contacts and locations

271

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Central trial contact

First line of email MUST contain NCT # and Site #.; BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Data sourced from clinicaltrials.gov

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