Study on mRNA-2808 for Patients with Relapsed or Hard-to-Treat Multiple Myeloma

Sponsor: ModernaTX, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07116616

This clinical trial is testing the safety and tolerability of a new treatment, mRNA-2808, for patients with multiple myeloma that has returned or is not responding to previous treatments.

Patient Parameters

Program Overview

The aim of this study is to determine if the new treatment, mRNA-2808, is safe and well-tolerated in patients who have multiple myeloma that has either come back after treatment or has not responded to standard therapies.

Eligibility Criteria

Inclusion Criteria

  • Have multiple myeloma that has returned or is not responding to treatment.
  • Have previously been treated with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
  • Have measurable disease, which can be shown by one of the following:
    • M-protein in the blood of at least 0.5 grams per deciliter.
    • M-protein in the urine of at least 200 milligrams in a 24-hour period.
    • Free light chain in the blood of at least 100 milligrams per liter with an abnormal ratio.
    • A plasmacytoma (a type of tumor) that is at least 2 centimeters in size.
    • Bone marrow plasma cells greater than 30%.

Exclusion Criteria

  • Have myeloma that has spread to the brain or symptoms suggesting brain involvement.
  • Have active plasma cell leukemia, which means having a high number of plasma cells in the blood.
  • Have received radiation or chemotherapy within 2 weeks before starting the study, except for limited radiation for symptom relief after discussion with the study team.
  • Have received antibody-based treatments within 21 days before starting the study.
  • Have taken proteasome inhibitors or immunomodulatory drugs within 14 days before starting the study.
  • Have had an autologous stem cell transplant within 100 days before starting the study.
  • Have had an allogeneic stem cell transplant within 180 days before starting the study.
  • Have had genetically modified cell therapy, like CAR-T cell therapy, within 12 weeks before starting the study.
  • Have taken high doses of corticosteroids within 14 days before starting the study.

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham Hospital35233BirminghamAlabama
UCSF94143San FranciscoCalifornia
Emory University Hospital30322AtlantaGeorgia
Mass General Brigham02114BostonMassachusetts
Tisch Cancer Institute at Mount Sinai10029New YorkNew York
Memorial Sloan-Kettering Cancer Center10065New YorkNew York
Atrium Health Levine Cancer Institute28204CharlotteNorth Carolina
Penn Medicine19104PhiladelphiaPennsylvania
Sarah Cannon Research Institute37203NashvilleTennessee
The Medical College of Wisconsin53226MilwaukeeWisconsin

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