Relapsed or Refractory Multiple Myeloma
Conditions
Keywords
relapsed or refractory multiple myeloma, RRMM, multiple myeloma, MM
Brief 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).
Interventions
DRUGmRNA-2808
intravenous
Sponsors
ModernaTX, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Dose-limiting Toxicity | Up to 28 days |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to 15 months |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax) | Up to 1 year |
| Area Under the Concentration-time Curve (AUC) | Up to 1 year |
| Maximum Effect/Concentration of the Expressed Protein (Emax) | Up to 1 year |
| Area Under the Effect Concentration (AUEC) | Up to 1 year |
| Overall Response Rate (ORR) | Up to 3 years |
| Duration of Response (DOR) | Up to 3 years |
| Progression-free Survival (PFS) based on International Myeloma Working Group (IMWG) Response Criteria | Up to 3 years |
| Overall Survival (OS) | Up to 3 years |
| Number of Participants with Minimal Residual Disease Negativity Status | Up to 3 years |
| Number of Participants with Antibodies to mRNA-2808 Derived Proteins | Up to 1 year |
| Number of Participants with Antibodies to mRNA-2808 Components | Up to 1 year |
Countries
United States
Contacts
CONTACTModerna WeCare Team
Outcome results
None listed