Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

Summary

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

Official Title

A Phase 1/2, Open-label, Multicenter Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma

Keywords

Relapsed or Refractory Multiple Myeloma, RRMM, multiple myeloma, MM, Plasma Cell Neoplasms, mRNA-2808

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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%

You CAN'T join if...

  • 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

  • UCSF
    San Francisco California 94143 United States
  • The Medical College of Wisconsin
    Milwaukee Wisconsin 53226 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
ModernaTX, Inc.
ID
NCT07116616
Phase
Phase 1/2 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 166 study participants
Last Updated