Health TrialsbyHealthPanel

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

ConditionRelapsed or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorModernaTX, Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • mRNA-2808

    Drug

    intravenous or subcutaneous

Treatment groups

190 Participants
are divided into 1 treatment group
Group A: mRNA-2808Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Dose-limiting Toxicity

Time frame
Up to 28 days
2

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Time frame
Up to 15 months

Secondary outcomes

1

Maximum Plasma Concentration (Cmax)

Time frame
Up to 1 year
2

Area Under the Concentration-time Curve (AUC)

Time frame
Up to 1 year
3

Maximum Effect/Concentration of the Expressed Protein (Emax)

Time frame
Up to 1 year
4

Area Under the Effect Concentration (AUEC)

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ModernaTX, Inc.

Lead sponsor

Source ClinicalTrials.gov
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