A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma

Sponsor: ModernaTX, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07116616

This study assesses the safety and tolerability of intravenous mRNA-2808 in participants with relapsed or refractory multiple myeloma. Eligible participants must have prior exposure to a proteasome inhibitor, an IMiD, and a CD38 monoclonal antibody, with measurable disease criteria such as specific M-protein levels, FLC levels, plasmacytoma size, or bone marrow plasma cell percentage.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).

Eligibility Criteria

Inclusion Criteria

  • RRMM with prior exposure to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD38) monoclonal antibody.

  • Measurable disease defined as at least 1 of the following:

    • Serum M-protein ≥0.5 grams/deciliter
    • Urine M-protein ≥200 milligrams (mg)/24-hour
    • Involved free light chain (FLC) ≥100 mg/liter and an abnormal FLC ratio
    • Plasmacytoma with a single diameter ≥2 centimeters
    • Bone marrow plasma cells >30%

Key

Exclusion Criteria

  • Known central nervous system (CNS) myeloma or clinical signs and symptoms of CNS involvement of myeloma.
  • Active plasma cell leukemia, defined as peripheral blood plasma cells ≥20%.
  • Radiotherapy or cytotoxic chemotherapy within 2 weeks prior to Day 1 (Baseline), except palliative radiotherapy of limited field is permissible within 2 weeks after discussion with the Sponsor medical monitor.
  • Antibody-based immunotherapy (monoclonal antibody, bispecific antibody, antibody drug conjugate) within 21 days prior to Day 1 (Baseline).
  • Proteasome inhibitor therapy or immunomodulatory agent within 14 days prior to Day 1 (Baseline).
  • Autologous hematopoietic cell transplant within 100 days prior to Day 1 (Baseline).
  • Allogeneic hematopoietic cell transplant within 180 days prior to Day 1 (Baseline).
  • Genetically modified adoptive autologous or allogeneic cellular therapy (for example, chimeric antigen receptor T cell, chimeric antigen receptor natural killer) within 12 weeks prior to Day 1 (Baseline).
  • Corticosteroid therapy ≥140 mg prednisone or equivalent cumulative dose within 14 days prior to Day 1 (Baseline).

Note: Other inclusion and exclusion criteria may apply.

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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