mRNA-2808 for Relapsed or Refractory Multiple Myeloma
A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
Recruiting
Phase 1Phase 2Interventional Study
Relapsed or Refractory Multiple Myeloma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
166 (estimated)
Sponsor
ModernaTX, Inc. · Industry
Who this trial is looking for
This trial is looking for people with a serious form of blood cancer that has not responded to previous treatments. Participants will receive a new treatment called mRNA-2808 to check how safe it is.
Are You a Good Fit for This Trial?
You may be able to join if
I have relapsed or refractory multiple myeloma.
I have taken a proteasome inhibitor before.
I have taken an immunomodulatory drug before.
I have taken an anti-CD38 monoclonal antibody before.
I have measurable disease based on specific criteria.
You may not be able to join if
I have known central nervous system myeloma.
I have active plasma cell leukemia.
I received radiotherapy or chemotherapy in the last 2 weeks.
I took antibody-based immunotherapy in the last 21 days.
I took a proteasome inhibitor or immunomodulatory agent in the last 14 days.
I had an autologous stem cell transplant in the last 100 days.
I had an allogeneic stem cell transplant in the last 180 days.
I received genetically modified cellular therapy in the last 12 weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).
Trial Locations
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Status
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.
* Measurable disease defined as at least 1 of the following:
* Serum M-protein ≥0.5 grams/deciliter
* Urine M-protei…
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 exclusion criteria may apply.
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