ClinicalTrials.gg
Sign In
RecruitingNCT07116616Updated Sep 23, 2026

A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 1/2 interventional study of mRNA-2808 in Relapsed or Refractory Multiple Myeloma, sponsored by ModernaTX, Inc.. Recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Primary conditionMultiple MyelomaRegistry: RecurrenceReclassifiedWhy we changed it
Registry
Recurrence — the first condition term the registry derived for this study.
ClinicalTrials.gg
Multiple Myeloma
Why
  1. Recurrence describes something many studies share rather than a condition a study is about.
  2. The study's listed conditions name Multiple Myeloma.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by ModernaTX, Inc. (part of Moderna, Inc.) · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
190
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Relapsed or Refractory Multiple Myeloma

Browse trials for

Keywords

  • relapsed or refractory multiple myeloma
  • RRMM
  • multiple myeloma
  • MM
03

In context

Multiple Myeloma Reclassified

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's planned enrollment of 190 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

ModernaTX, Inc. is the lead sponsor of 119 studies on the registry; 18 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 35 (55%) have results posted.

Browse ModernaTX, Inc. studies →All Moderna, Inc. studies →

Compared within Multiple Myeloma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.

  • 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).
  • 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).
  • therapy ≥140 mg prednisone or equivalent cumulative dose within 14 days prior to Day 1 (Baseline).

Note: Other inclusion and exclusion criteria may apply.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
190 participants (estimated)

Study arms

  • Experimental
    mRNA-2808

    Participants will receive mRNA-2808.

    Drug: mRNA-2808

Interventions

  • DrugmRNA-2808

    intravenous or subcutaneous

06

What researchers measure

Primary outcomes

  1. Number of Participants with Dose-limiting Toxicity

    Time frame: Up to 28 days

  2. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 15 months

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: Up to 1 year

  2. Area Under the Concentration-time Curve (AUC)

    Time frame: Up to 1 year

  3. Maximum Effect/Concentration of the Expressed Protein (Emax)

    Time frame: Up to 1 year

  4. Area Under the Effect Concentration (AUEC)

    Time frame: Up to 1 year

  5. Overall Response Rate (ORR)

    Time frame: Up to 3 years

  6. Duration of Response (DOR)

    Time frame: Up to 3 years

  7. Progression-free Survival (PFS) based on International Myeloma Working Group (IMWG) Response Criteria

    Time frame: Up to 3 years

  8. Overall Survival (OS)

    Time frame: Up to 6 years

  9. Number of Participants with Minimal Residual Disease Negativity Status

    Time frame: Up to 3 years

  10. Number of Participants with Antibodies to mRNA-2808 Derived Proteins

    Time frame: Up to 1 year

  11. Number of Participants with Antibodies to mRNA-2808 Components

    Time frame: Up to 1 year

07

Study locations

10 of 10 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Jun 2030, 56 months after the start.

Of 98 industry-sponsored phase 1/2 interventional studies under Multiple Myeloma, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 90. This study's planned 56 months is below that.

Counting every sponsor, half of 201 studies reached it within 65 months; a quarter within 44 and three quarters within 92.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2025
First posted
Aug 11, 2025
StartActual
Sep 30, 2025
Primary completionEst.
Jun 17, 2030
CompletionEst.
Jun 17, 2032
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07116616
Lead sponsor
ModernaTX, Inc.
Responsible party
Sponsor
First posted
Aug 11, 2025
Start date
Sep 30, 2025
Primary completion
Jun 17, 2030 (estimated)
Completion
Jun 17, 2032 (estimated)
Last update
Sep 23, 2026

Study contacts

Moderna WeCare Team
Contact
WeCareClinicalTrials@modernatx.com
+1-866-663-3762

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Multiple Myeloma →

Other studies from this sponsor

ModernaTX, Inc. →

Start the discussion