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LymphomaOpen to EnrollmentPhase 3

MULTIPLE MYELOMA: Post ASCT: 1st Line maintenance: EXCLIBER-Maintenance

A Phase 3, two-stage, randomized, multi-center, controlled, open-label study comparing iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM)

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Study snapshot

Title
Celgene BMS IM048022
Malignancy
Multiple myeloma
Stage
Stage 4
Disease setting
Post- autologous stem cell transplant
Line of therapy
1st line maintenance
Investigational agent
Iberdomide
Drug class
Immune stimulator
Principal investigator
Jason Chandler, MD
Sponsor
Abbvie, BMS
Path
multiple myeloma
Randomized
Yes
ClinicalTrials.gov ID
NCT05827016

Eligibility and objectives

Key eligibility criteria details

  • Confirmed diagnosis of symptomatic multiple myeloma
  • ECOG PS 0-2
  • 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
  • No PD or clinical replapse following ASCT or non-responsiveness to primary therapy
  • No known CNS or meningeal involvement

Objective

  • Primary
    • PFS
  • Secondary
    • MRD negativity
    • OS
    • PK
    • Safety
    • TTP
    • TTNT
    • ORR
    • QOL

Treatment details