Actively Recruiting
ELISA in Relapsed/Refractory MM
Led by Massachusetts General Hospital · Updated on 2026-03-12
30
Participants Needed
3
Research Sites
172 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label phase 2 study of elranatamab in combination with isatuximab administered subcutaneously in patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy and who have had previous treatment with both immunomodulatory drugs (IMiDs) and a proteasome inhibitor (PI). The subcutaneous injection method of isatuximab administration, including the device used to administer isatuximab, is investigational.
CONDITIONS
Official Title
ELISA in Relapsed/Refractory MM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed and refractory multiple myeloma who have had at least 2 prior lines of therapy including immunomodulatory drugs and proteasome inhibitors
- Prior therapy with anti-CD38 and anti-BCMA targets allowed except anti-BCMA T cell engager; not refractory to anti-CD38 antibody
- Measurable multiple myeloma disease defined by serum monoclonal protein ≥ 0.5 g/dL, or urine monoclonal protein ≥ 200 mg in 24 hours, or serum free light chain ≥ 100 mg/L with abnormal kappa/lambda ratio
- Age 18 years or older
- Women of child-bearing potential must agree to use adequate contraception during and for months after study participation
- ECOG performance status 2 or better (Karnofsky ≥ 60%)
- Adequate organ and marrow function including ANC ≥ 1000/µL, platelet count ≥ 50,000/µL, hemoglobin ≥ 8 g/dL, creatinine clearance ≥ 30 mL/min, and liver function within specified limits
- Participants with prior or concurrent malignancy without interference to safety or efficacy assessment
- Cardiac function classified as New York Heart Association class 2B or better
- Ability to understand and sign informed consent
You will not qualify if you...
- Active plasma cell leukemia, POEMS syndrome, or amyloidosis
- Stem cell transplant within 12 weeks prior to enrollment or active graft-versus-host disease
- Ongoing Grade 2 or higher peripheral sensory or motor neuropathy
- History of peripheral neuropathy with prior BCMA therapy or Guillain-Barré syndrome variants, or Grade 3 or higher peripheral motor polyneuropathy
- Previous treatment with anti-BCMA bispecific T cell engager
- Currently receiving any investigational agents
- Myeloma therapy or investigational drug within 2 weeks before treatment start or unresolved adverse events from prior agents
- Known or suspected hypersensitivity to study drugs or device components
- Clinically significant cardiovascular events or conditions within 6 months prior to enrollment
- Known active hepatitis B, hepatitis C, HIV, or uncontrolled infections
- Any other active malignancy within 3 years except certain treated skin or in situ cancers
- Major surgery within 14 days prior to enrollment
- Recent or active suicidal ideation or psychiatric conditions increasing study risk
- Live attenuated vaccine within 30 days before first study dose
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
Research Team
N
Noopur Raje, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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