A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma

This study is researching an investigational drug called linvoseltamab ("study drug") in participants at moderate risk of developing multiple myeloma (about 3 to 10% average annual risk), a group that consists of patients with precancerous conditions called High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM). The primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of HR-MGUS and NHR-SMM. The study is looking at several other research questions,

Trial Details

NCT ID
NCT06140524
Phase
PHASE2
Sponsor
Regeneron Pharmaceuticals
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • Linvoseltamab
Locations (sample)
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Ann Arbor, Michigan, United States|42.27756,-83.74088
  • New York, New York, United States|40.71427,-74.00597
  • Stony Brook, New York, United States|40.92565,-73.14094

Key Eligibility Criteria

  • HR-MGUS or NHR-SMM as defined in the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Adequate hematologic and hepatic function, as described in the protocol
  • Estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) equation

For full eligibility, visit ClinicalTrials.gov.

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