Actively Recruiting
Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma
Led by Massachusetts General Hospital · Updated on 2026-01-14
50
Participants Needed
2
Research Sites
343 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main goal of this phase II study is to evaluate the overall response rate of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. The study drugs provided for research purposes are isatuximab and belantamab mafodotin.
CONDITIONS
Official Title
Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has given voluntary signed informed consent before any study procedures
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Age 18 years or older
- Measurable multiple myeloma defined by specific protein levels in blood or urine
- Previously treated relapsed and refractory multiple myeloma with at least one prior therapy
- Prior therapy must include at least 2 cycles of lenalidomide and 2 cycles of a proteasome inhibitor
- Disease progression on or within 60 days of last therapy completion
- Absolute neutrophil count (ANC) of 1000/µL or higher
- Platelet count of 75,000/µL or higher
- Hemoglobin level of 8 g/dL or higher
- Creatinine clearance of 30 mL/min or higher
- Urine albumin/creatinine ratio less than 500 mg/g or negative/trace dipstick
- Adequate liver function with bilirubin and liver enzyme levels within specified limits
- Ability to take daily acetylsalicylic acid (ASA) or approved anticoagulants
- Enrollment in and compliance with the Pomalyst REMS program
- Women of childbearing potential must use effective contraception and have negative pregnancy tests
- Men must use barrier contraception if sexually active with women of childbearing potential and refrain from sperm donation
- Ability to swallow pomalidomide capsules whole
You will not qualify if you...
- Current corneal epithelial disease except mild changes
- Use of contact lenses during study participation
- Myeloma therapy or investigational drugs within 2 weeks before treatment start
- Receiving other investigational agents
- Prior anti-CD38 monoclonal antibody therapy within 6 months
- Prior anti-BCMA therapy
- Plasmapheresis within 7 days before treatment start
- Primary refractory disease
- Use of high dose corticosteroids
- Pregnancy or breastfeeding
- History of other malignancies unless disease-free for 3 years or approved exceptions
- Active plasma cell leukemia, POEMS syndrome, or primary AL amyloidosis
- Positive for HIV, hepatitis B, or hepatitis C without sustained response
- Peripheral neuropathy grade 2 or higher despite treatment
- Hypersensitivity to study drugs
- Recent allogeneic or autologous stem cell transplant within specified timeframes
- Significant medical conditions posing risk or interfering with study
- Major surgery within 4 weeks before treatment
- Live vaccines within 30 days before treatment
- Toxicity from previous cancer therapy not resolved to baseline except alopecia or peripheral neuropathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
A
Andrew Yee, 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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