BCMA Bispecific Antibody Therapy for Patients with Multiple Myeloma After CAR T-Cell Therapy Relapse

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07009899

Provider View

This clinical trial is testing a new treatment called linvoseltamab for patients with multiple myeloma whose cancer has returned after receiving BCMA CAR T-cell therapy. The study aims to see how well this new treatment works and how safe it is.

Patient Parameters

Program Overview

The study is focused on patients with multiple myeloma, a type of blood cancer, who have experienced a relapse after undergoing BCMA CAR T-cell therapy. The main goal is to evaluate the effectiveness and safety of a new treatment called linvoseltamab. This trial is being conducted at a single center and involves patients who have previously received either standard or investigational BCMA CAR T-cell therapy.

Description

This study is designed to test the effectiveness and safety of linvoseltamab in patients with multiple myeloma who have relapsed after BCMA CAR T-cell therapy. The primary goal is to measure how well patients respond to linvoseltamab treatment. Participants must be at least 18 years old and have a performance status that allows them to carry out daily activities with some limitations. They should have received BCMA CAR T-cell therapy at least six months before joining the study, although some exceptions apply. Participants must have measurable disease and adequate liver function. They should be able to understand and sign a consent form to participate.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score between 0 and 3, indicating varying levels of activity.
  • Have received BCMA CAR T-cell therapy as their last treatment at least six months ago, with some exceptions for those less than six months if certain conditions are met.
  • Must have measurable disease according to specific criteria.
  • Have adequate liver function, with specific limits on liver enzyme levels.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Have previously received other BCMA-directed therapies or T cell engaging therapies.
  • Have a history of certain neurological conditions or seizures within the past year.
  • Have serious medical or psychiatric conditions that could interfere with the study.
  • Have had an organ transplant requiring immunosuppressive therapy.
  • Be HIV positive or have active hepatitis A, B, or C infections.
  • Have allergies to study medications or their components.
  • Have other cancers requiring treatment, except for multiple myeloma and secondary amyloidosis.
  • Have certain heart conditions or recent heart issues.
  • Have had major surgery within the past 14 days, with some exceptions.
  • Have had a serious infection requiring antibiotics within the past 14 days.
  • Be participating in other clinical trials or have taken investigational drugs recently.
  • Have uncontrolled medical conditions that pose excessive risk.
  • Be pregnant or breastfeeding.
  • Be of childbearing potential or a sexually active man unwilling to use effective contraception during and after the study.

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