mRNA-2736 for Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
NCT ID: NCT05918250
Last Updated: 2023-08-18
Study Results
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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WITHDRAWN
PHASE1
INTERVENTIONAL
2023-08-15
2026-05-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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mRNA-2736
Participants will receive mRNA-2736.
mRNA-2736
mRNA-2736 will be administered IV.
Interventions
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mRNA-2736
mRNA-2736 will be administered IV.
Eligibility Criteria
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Inclusion Criteria
* 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
* Active plasma cell leukemia, defined as peripheral blood plasma cells ≥20%. History of plasma cell leukemia is allowed.
* 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, radioimmunoconjugate) within 21 days prior to Day 1 (Baseline).
* Proteasome inhibitor therapy within 14 days prior to Day 1 (Baseline).
* Immunomodulatory agent therapy within 7 days of 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). Participants should have no evidence or ongoing treatment for acute or chronic graft versus host disease.
* Genetically modified adoptive 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).
* Active hepatitis B or C, or laboratory evidence for a chronic infection with hepatitis B or C at the time of screening. Participants with a past or resolved hepatitis B infection (presence of hepatitis B core antibody and absence of hepatitis B surface antigen) are eligible. Participants positive for hepatitis C virus (HCV) antibody are eligible only if negative for HCV RNA.
18 Years
ALL
No
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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UAB Hospital
Birmingham, Alabama, United States
University of Miami Health System
Miami, Florida, United States
Washington University Medical Center
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Ohio State University Hospital
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
UW Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Countries
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Other Identifiers
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2023-503286-38-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
mRNA-2736-P101
Identifier Type: -
Identifier Source: org_study_id
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