A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment

This study is researching an experimental drug called linvoseltamab (called "study drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are eligible for high dose chemotherapy with autologous stem cell transplantation (transplant-eligible) or ineligible for autologous stem cell transplantation (transplant-ineligible). The aim of this clinical trial is to study the safety, tolerability (how the body reacts to the drug), and effectiveness (tumor shrinkage) of linvoseltamab in study participants with NDMM as a first step in determining if the study drug h

Trial Details

NCT ID
NCT05828511
Phase
PHASE1 / PHASE2
Sponsor
Regeneron Pharmaceuticals
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • Linvoseltamab
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311
  • Denver, Colorado, United States|39.73915,-104.9847
  • Louisville, Kentucky, United States|38.25424,-85.75941
  • Detroit, Michigan, United States|42.33143,-83.04575

Key Eligibility Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Confirmed diagnosis of symptomatic Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnosis criteria, as described in the prot…
  • Response-evaluable myeloma, according to the 2016 IMWG response criteria, as defined in the protocol
  • No prior therapy for MM, with the exception of prior emergent or palliative radiation and up to 1 month of single-agent corticosteroids, with washo…

For full eligibility, visit ClinicalTrials.gov.

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