IMMUNOPLANT Study for Newly Diagnosed Multiple Myeloma

Sponsor: Dickran Kazandjian, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06376526

Provider View

This clinical trial is exploring whether the drug Linvoseltamab can help patients with newly diagnosed multiple myeloma by changing their disease status and extending the time their disease is controlled. The study also aims to understand the positive and negative effects of Linvoseltamab on patients and their condition.

Patient Parameters

Program Overview

The purpose of this study is to find out if Linvoseltamab can help patients with newly diagnosed multiple myeloma by changing their disease status from minimal residual disease (MRD)-positive to MRD-negative, and by increasing the time the disease is kept under control. Researchers also want to learn about the effects, both good and bad, that Linvoseltamab has on participants and their condition.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with newly diagnosed multiple myeloma (NDMM) according to specific medical criteria before starting treatment.
  • Have received an initial combination therapy with at least two of the following: Immunomodulatory drug (IMiD), proteosome inhibitor (PI), and/or anti-CD38.
  • Achieved a very good partial response or better but still have minimal residual disease (MRD+) after at least 4 cycles of combination therapy.
  • Aged 18 years or older.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory. Patients with a score of 2 due to myeloma symptoms like pain may be allowed after discussion.
  • Have adequate organ function, including:
    • Neutrophil count of at least 1,000 cells/mcL.
    • Platelet count of at least 50,000/mcL.
    • Hemoglobin level of at least 8 g/dL (transfusions allowed).
    • Normal liver and kidney function as indicated by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 6 months after.
  • Willing and able to provide written informed consent and comply with study procedures.

Exclusion Criteria

  • Have received other systemic therapies for multiple myeloma besides the initial combination therapy.
  • Currently receiving any other investigational drugs.
  • Have received a live vaccine within 4 weeks before starting the study treatment.
  • Have allergies to medications used in the study or any related drugs.
  • Have certain infections like HIV, hepatitis B, or hepatitis C that are not well-controlled.
  • Have a history of severe allergic reactions to similar drugs.
  • Women who are breastfeeding or unwilling to use effective contraception.
  • Have serious heart conditions or recent heart attacks.
  • Have uncontrolled illnesses or infections that could interfere with the study.
  • Have another active cancer requiring treatment in the past 12 months.
  • Have any condition that the study doctor believes would compromise the patient's well-being or the study's integrity.
  • Have impaired decision-making capacity.

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