Actively Recruiting
A Phase II Study of ISABELA: Isatuximab, Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma
Led by Massachusetts General Hospital · Updated on 2026-01-14
50
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combination of four drugs—isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone—in people with relapsed and refractory multiple myeloma, a type of cancer. This phase II study aims to determine the overall response rate to this treatment combination. About 50 participants will be involved, and treatment will continue until the disease progresses, side effects occur, or participants choose to withdraw. Participants will receive isatuximab by intravenous infusion daily during the first 28-day cycle on days 1, 8, 15, and 22, then on days 1 and 15 of subsequent cycles. Belantamab mafodotin will be given intravenously every eight weeks after isatuximab infusion. Pomalidomide is taken orally once daily on days 1 through 21 of each cycle, while dexamethasone is taken orally on specific days within each cycle. Participants will keep drug diaries to record their intake of pomalidomide and dexamethasone. Throughout the study, participants will undergo assessments to monitor their response to treatment, including measuring the overall response rate four weeks after treatment starts. Researchers will also track adverse events, progression-free survival for up to 10 years, and overall survival. Study visits include clinical evaluations and monitoring to ensure safety and treatment adherence. The study began in May 2024 and is expected to continue until the end of 2030.
CONDITIONS
Brief 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 signed informed consent before any study procedures
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Age 18 years or older
- Measurable multiple myeloma by serum or urine monoclonal protein or abnormal serum free light chain levels
- Previously treated relapsed and refractory multiple myeloma with at least one prior therapy including lenalidomide and a proteasome inhibitor
- Disease progression on or within 60 days of last therapy
- 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
- Spot urine albumin/creatinine ratio less than 500 mg/g or negative/trace urine dipstick
- Adequate liver function with bilirubin less than 1.5 times upper limit of normal and AST/ALT less than 2.5 times upper limit of normal
- Able to take daily acetylsalicylic acid (ASA) or equivalent anticoagulation
- Registered and compliant with the Pomalyst REMS program
- Women of childbearing potential must use effective contraception and have negative pregnancy tests as required
- Men sexually active with women of childbearing potential must use barrier contraception for 6 months after last dose
- Able to swallow pomalidomide capsules whole
You will not qualify if you...
- Current corneal epithelial disease beyond mild changes
- Use of contact lenses during study
- Recent 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 prior to treatment
- Primary refractory disease
- Use of high dose corticosteroids; low dose allowed for other conditions
- Pregnancy, lactation, or planned breastfeeding
- Prior malignancies other than multiple myeloma unless disease-free for 3 years or approved exceptions
- Active plasma cell leukemia, POEMS syndrome, or primary AL amyloidosis
- Positive tests for HIV, hepatitis B or C (with exceptions)
- Peripheral neuropathy grade 2 or higher despite treatment
- Hypersensitivity to study drugs
- Recent allogeneic or autologous stem cell transplant within specified timeframes
- Significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illnesses
- Other medical, psychiatric, or social conditions interfering with study participation
- Major surgery within 4 weeks prior to treatment
- Live or live-attenuated vaccines within 30 days prior to treatment
- Unresolved toxicity from previous anticancer therapy except alopecia and peripheral neuropathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression, adverse events, or withdrawal of consent.
Participants receive isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone to treat relapsed and refractory multiple myeloma.
1 to 4 visits per cycle including intravenous infusions on specific days and daily oral medication during each 28-day cycle
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
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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