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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2032-06-17

Brief Summary

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

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Detailed Description

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Conditions

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Relapsed or Refractory Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mRNA-2808

Participants will receive mRNA-2808.

Group Type EXPERIMENTAL

mRNA-2808

Intervention Type DRUG

intravenous

Interventions

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mRNA-2808

intravenous

Intervention Type DRUG

Eligibility Criteria

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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%

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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