Study on Linvoseltamab to Remove Abnormal Plasma Cells in Adults with High-Risk Conditions Leading to Multiple Myeloma

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06140524

Provider View

This study is testing a new drug, Linvoseltamab, to see if it can remove abnormal plasma cells in adults with high-risk conditions that could lead to multiple myeloma. The study will also check how safe the drug is and how well patients tolerate it.

Patient Parameters

Program Overview

The main goal of this study is to find out if Linvoseltamab can effectively remove abnormal plasma cells in people with high-risk conditions that might lead to multiple myeloma. Researchers will also look at how safe the drug is and how well patients can handle it. Participants will start with small doses of Linvoseltamab that gradually increase before receiving the full dose. The study is divided into two parts: Part 1 will test different doses in small groups to see short-term side effects, and Part 2 will involve more participants to further study the drug's effects and safety. Researchers will also explore how many participants see improvement, what side effects occur, how much of the drug is in the blood, and if the body creates antibodies against the drug.

Eligibility Criteria

Inclusion Criteria

  • Have high-risk monoclonal gammopathy of undetermined significance (HR-MGUS) or non-high-risk smoldering multiple myeloma (NHR-SMM).
  • Be in good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood and liver function.
  • Have a kidney function with an estimated filtration rate of 30 mL/min/1.73 m2 or higher.

Exclusion Criteria

  • Have high-risk smoldering multiple myeloma (SMM).
  • Show any signs of myeloma-defining events.
  • Have been diagnosed with certain other blood disorders like systemic light-chain amyloidosis or Waldenström macroglobulinemia.
  • Have significant heart or blood vessel disease within the last 3 months.
  • Have had a serious infection requiring hospital treatment or IV antibiotics within 28 days before starting the study drug.
  • Have uncontrolled infections like HIV, hepatitis B, or hepatitis C.

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