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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

Phase 3
Recruiting
Conditions
Multiple Myeloma
Registration Number
JPRN-jRCT2031230223
Lead Sponsor
Acosta Jorge
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
1216
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 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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