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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-2808 | Experimental | Participants will receive mRNA-2808. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-2808 | Drug | intravenous |
|
| Measure | Description | 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 |
| Measure | Description | 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) |
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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:
Key Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moderna WeCare Team | Contact | +1-866-663-3762 | WeCareClinicalTrials@modernatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Hospital | Recruiting | Birmingham | Alabama | 35233 | United States | |
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| 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 |
| UCSF |
| Recruiting |
| San Francisco |
| California |
| 94143 |
| United States |
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
| Mass General Brigham | Not yet recruiting | Boston | Massachusetts | 02114 | United States |
| Tisch Cancer Institute at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
| Memorial Sloan-Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| Atrium Health Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
| Penn Medicine | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
| The Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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