Recruiting NCT07116616
A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mRNA-2808.
- Who it may be relevant to
- Registry conditions: Relapsed or Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1/2, Open-label, Multicenter Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
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).
Interventions
- Drug mRNA-2808
intravenous
Primary outcome measures
- Number of Participants with Dose-limiting Toxicity [Time frame: Up to 28 days]
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to 15 months]
Secondary outcome measures (11)
- Maximum Plasma Concentration (Cmax) [Time frame: Up to 1 year]
- Area Under the Concentration-time Curve (AUC) [Time frame: Up to 1 year]
- Maximum Effect/Concentration of the Expressed Protein (Emax) [Time frame: Up to 1 year]
- Area Under the Effect Concentration (AUEC) [Time frame: Up to 1 year]
- Overall Response Rate (ORR) [Time frame: Up to 3 years]
- Duration of Response (DOR) [Time frame: Up to 3 years]
- Progression-free Survival (PFS) based on International Myeloma Working Group (IMWG) Response Criteria [Time frame: Up to 3 years]
- Overall Survival (OS) [Time frame: Up to 3 years]
- Number of Participants with Minimal Residual Disease Negativity Status [Time frame: Up to 3 years]
- Number of Participants with Antibodies to mRNA-2808 Derived Proteins [Time frame: Up to 1 year]
- Number of Participants with Antibodies to mRNA-2808 Components [Time frame: Up to 1 year]
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%
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 10 centers
- University of Alabama at Birmingham Hospital — Birmingham
- UCSF — San Francisco
- Emory University Hospital — Atlanta
- Mass General Brigham — Boston
- Tisch Cancer Institute at Mount Sinai — New York
- Memorial Sloan-Kettering Cancer Center — New York
- Atrium Health Levine Cancer Institute — Charlotte
- Penn Medicine — Philadelphia
- … and 2 more centers
Identifiers
NCT: NCT07116616 · mRNA-2808-P101