Study Comparing Linvoseltamab to a Combination of Elotuzumab, Pomalidomide, and Dexamethasone for Adults with Relapsed or Refractory Multiple Myeloma

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05730036

Provider View

This clinical trial is testing a new drug called linvoseltamab to see how well it works compared to a combination of three existing drugs (elotuzumab, pomalidomide, and dexamethasone) in adults with multiple myeloma that has returned or is not responding to previous treatments.

Patient Parameters

Program Overview

The study aims to find out if linvoseltamab is safe and effective for treating multiple myeloma that has come back or needs more treatment after one to four previous therapies. Participants will be divided into two groups: one will receive linvoseltamab, and the other will receive a combination of elotuzumab, pomalidomide, and dexamethasone (EPd). Researchers will compare how long each treatment works, how many patients see improvement, what side effects occur, and if there is any improvement in pain or survival rates.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a performance status score of 1 or less, or 2 if due to myeloma symptoms like pain.
  • Must have had 1 to 4 previous treatments for multiple myeloma, including lenalidomide and a proteasome inhibitor, and show disease progression after the last treatment.
  • Must have measurable disease for response assessment.
  • Must have adequate blood, liver, kidney, and heart function, and sufficient bone marrow reserves.
  • Must have a life expectancy of at least 6 months.

Exclusion Criteria

  • Cannot have plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome.
  • Cannot have been treated with elotuzumab or pomalidomide before.
  • Cannot have known brain lesions or meningeal involvement from multiple myeloma.
  • Cannot have had any systemic anti-cancer therapy recently.
  • Cannot have had a stem cell transplant recently.
  • Cannot have been treated with certain BCMA-directed therapies.
  • Cannot have a history of certain brain conditions or infections.
  • Cannot have uncontrolled infections like HIV, hepatitis B, or hepatitis C.

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