Relapsed or Refractory Multiple MyelomaPhase 1/2NCT07116616
A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1/2 study testing mRNA-2808 in people with Relapsed or Refractory Multiple Myeloma, run by ModernaTX, Inc. at 10 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- mRNA-2808
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 10 sitesUnited States
- Study dates
- 30 Sep 2025to 17 Jun 2032
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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).
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- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
- Recruiting
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35233
- Recruiting
Mass General Brigham
Boston, Massachusetts, 02114
- Recruiting
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28204
- Recruiting
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Recruiting
Tisch Cancer Institute at Mount Sinai
New York, New York, 10029
- Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
- Recruiting
Penn Medicine
Philadelphia, Pennsylvania, 19104
- Recruiting
UCSF
San Francisco, California, 94143
About this study
Official title: A Phase 1/2, Open-label, Multicenter Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- mRNA-2808
- Keywords
- relapsed or refractory multiple myeloma, RRMM, multiple myeloma, MM
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-2808Drug
intravenous or subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| mRNA-2808 | Experimental | Participants will receive mRNA-2808. Receives: Drug: mRNA-2808 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-limiting Toxicity
Measured: Up to 28 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 15 months
Secondary outcomes (11)
Maximum Plasma Concentration (Cmax)
Measured: Up to 1 year
Area Under the Concentration-time Curve (AUC)
Measured: Up to 1 year
Maximum Effect/Concentration of the Expressed Protein (Emax)
Measured: Up to 1 year
Area Under the Effect Concentration (AUEC)
Measured: Up to 1 year
Overall Response Rate (ORR)
Measured: Up to 3 years
Duration of Response (DOR)
Measured: Up to 3 years
Progression-free Survival (PFS) based on International Myeloma Working Group (IMWG) Response Criteria
Measured: Up to 3 years
Overall Survival (OS)
Measured: Up to 6 years
Number of Participants with Minimal Residual Disease Negativity Status
Measured: Up to 3 years
Number of Participants with Antibodies to mRNA-2808 Derived Proteins
Measured: Up to 1 year
Number of Participants with Antibodies to mRNA-2808 Components
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start30 Sep 2025
- Primary completion17 Jun 2030 (estimated)
- Study completion17 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116616
- Sponsor's protocol ID
- mRNA-2808-P101
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-label, Multicenter Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07116616
- Acronym / sponsor ID
- mRNA-2808-P101
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Keywords
- relapsed or refractory multiple myeloma, RRMM, multiple myeloma, MM
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 17 Jun 2030 (estimated)
- Study completion
- 17 Jun 2032 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mRNA-2808 | Experimental | Drug: mRNA-2808Participants will receive mRNA-2808. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-2808intravenous or subcutaneous | Drug | mRNA-2808 |
Primary outcome
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
11 secondary outcomes
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 6 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mRNA-2808 in people with Relapsed or Refractory Multiple Myeloma, run by ModernaTX, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moderna WeCare Team (+1-866-663-3762, WeCareClinicalTrials@modernatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-limiting Toxicity (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.