Study on Linvoseltamab for Newly Diagnosed Multiple Myeloma Patients Who Have Not Yet Received Treatment

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05828511

Provider View

This clinical trial is testing a new drug called linvoseltamab to see if it is safe, well-tolerated, and effective in treating adults with newly diagnosed multiple myeloma who have not yet received any treatment.

Patient Parameters

Program Overview

The study is exploring a new drug, linvoseltamab, for adults with newly diagnosed multiple myeloma (NDMM) who are either eligible or ineligible for a stem cell transplant. The trial aims to understand how safe the drug is, how the body reacts to it, and how well it works in shrinking tumors. The study has two phases: Phase 1 focuses on finding the right dose and understanding side effects, while Phase 2 continues to assess side effects and evaluates the drug's effectiveness in reducing the cancer. Researchers are also looking at how the drug behaves in the body, including its presence in the blood and whether the body develops antibodies against it.

Eligibility Criteria

Inclusion Criteria

  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Confirmed diagnosis of symptomatic multiple myeloma according to specific medical criteria.
  • Have measurable disease as defined by standard criteria.
  • No previous treatment for multiple myeloma, except for certain limited treatments like radiation or short-term corticosteroids.
  • Must have adequate bone marrow, liver, kidney, and heart function.
  • Must be under 70 years old and have good organ function to be considered eligible for a stem cell transplant.

Exclusion Criteria

  • Cannot be receiving any other experimental treatments for multiple myeloma.
  • Cannot have known involvement of the central nervous system with multiple myeloma or certain neurological conditions.
  • Cannot have rapidly worsening symptoms that require immediate chemotherapy.
  • Cannot have certain types of multiple myeloma or related conditions, such as non-secretory multiple myeloma or active plasma cell leukemia.

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