Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

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).

Official Title

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) (EXCALIBER-Maintenance)

Keywords

Multiple Myeloma, Iberdomide, CC-220, Lenalidomide, MM, NDMM, Maintenance, Autologous stem cell transplant, ASCTm, Plasma Cell Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center
    Orange California 92868 United States
  • Local Institution - 0264
    Hermosillo SON 83270 Mexico

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting Investigator Inquiry Form FDA Safety Alerts and Recalls
ID
NCT05827016
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1216 study participants
Last Updated