UPCC 64425 A Phase 1/2, Open-label, Multicenter Study of mRNA-2808 in Participants with Relapsed or Refractory Multiple Myeloma

Research Study on Relapsed or Refractory Multiple Myeloma

Enrolling By Invitation
18 years or above
All
Phase 1/2
166 participants needed
1 Location

Brief description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Relapsed or Refractory Multiple Myeloma
  • Age: 18 years or above
  • Gender: All

Key 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.

The purpose of this study is to investigate relapsed or refractory multiple myeloma. This study investigates the condition in participants who have previously received specific treatments.

This study evaluates the safety and tolerability of an investigational medication in participants. It focuses on understanding how the medication is processed by the body and its effects on the participants.

  • Who can participate: Participants must have relapsed or refractory multiple myeloma and measurable disease as defined by specific clinical criteria.
  • Study details: Participants will receive an investigational medication. Some participants may receive a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Updated on 24 Jul 2026. Study ID: 26-0002
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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