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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

Status
Active
Cancer Type
Multiple Myeloma
Plasma cell neoplasm
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05827016
Protocol IDs
IM048-022 (primary)
NCI-2023-06571
2022-501515-14
U1111-1280-9492
Study Sponsor
Bristol-Myers Squibb

Summary

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).

Eligibility

  1. Confirmed diagnosis of symptomatic multiple myeloma (MM).
  2. Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2.
  3. 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.
  4. 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.

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