A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma
About the study
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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 Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Multiple Myeloma
Age
18+
Phase
PHASE3
Participants Needed
1216
Est. Completion Date
Jan 1, 2036
Treatment Type
INTERVENTIONAL
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov NCT Identifier
NCT05827016
Study Number
IM048022
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