Multiple Myeloma

Trial Protocol ID
USOR 23031: Relapsed/Refractory Multiple Myeloma Ph2 TECVAYLI in multiple myeloma patients (IIT MM165)

Investigator
Mohit Narang, MD

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma (OPTec/OPTal)

MOA: Teclistamab targets the CD3 receptor complex on T cells and BCMA on B-lineage cells. Talquetamab targets the D3 receptor complex in T cells and GPRC5D expressing cells.

Key Eligibility Criteria:

  • Must have documented diagnosis of MM according to the IMWG diagnostic criteria
  • Must have received 2 or more prior MM therapies including a PI, IMiD and CD38 antibody
  • Patients with a high tumor burden, defined as having ≥60% plasma cell infiltrate on the bone marrow biopsy or aspirate, whichever is higher, or with multiple extramedullary disease sites or plasmacytomas are excluded
  • Patients with a rapidly progressing disease per investigator assessment are excluded

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

Investigator
Jose Mendoza, MD

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