Clinical Trial

Trial Protocol ID USOR 22244: Ph3 Iberdomide Maintenance Following Autologous Stem Cell Transplant in newly dx MM

Trial Description

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) (IM048022)

MOA: Cereblon E3 ubiquitin ligase modulating agent, IMiD (thalidomide and its analogues)

Key Eligibility 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 PI and IMiD with/without a CD38 monoclonal antibody/VCd and followed by a single/tandem ASCT
  • Participants within 12 months (single transplant) or 15 months (tandem transplant) from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation
  • Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy excluded
  • Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma excluded

Contact us regarding Clinical Trials at MOHRSCH@usoncology.com or call us at 877-664-7724

Investigator

  • Jose Mendoza, MD

Disease Types

Sponsor

  • Bristol-Myers Squibb

ClinicalTrials.gov NCT ID

  • NCT05827016