Actively Recruiting
A Study to Investigate Safety and Clinical Activity of Belantamab Mafodotin in Combination With Lenalidomide, Dexamethasone and Nirogacestat in Patients With Transplant Ineligible Newly Diagnosed Multiple Myeloma
Led by Hellenic Society of Hematology · Updated on 2023-10-24
36
Participants Needed
2
Research Sites
172 weeks
Total Duration
On this page
Sponsors
H
Hellenic Society of Hematology
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 1/2, open-label study designed to assess the safety and clinical activity of different belantamab mafodotin doses in combination with lenalidomide, dexamethasone and nirogacestat in patients with transplant ineligible newly diagnosed multiple myeloma. This will be a 2-part study. In part 1 participants will be enrolled in one cohort to receive belantamab mafodotin in combination with lenalidomide, dexamethasone and nirogacestat and will determine the recommended phase 2 dose (RP2D) to be further evaluated for safety and clinical activity in the dose expansion cohort. The RP2D dose will be used in future studies in the transplant-ineligible newly diagnosed multiple myeloma (NDMM) setting. In the dose expansion phase (Part 2) an expansion cohort will be treated with the RP2D. The expansion cohort will randomize participants (1:1) in two groups to evaluate two alternate dose modification guidelines for corneal AEs. Part 2 of the study will also evaluate an alternative dose modification guideline for corneal adverse events (AEs). Overall, approximately 36 participants will be enrolled in the study. Participant follow-up will continue up to 3 years after the last participant is enrolled (follow-up period range: 3-4 years). The estimated accrual period will be 12 months, corresponding to an approximate total study duration of 4 years.
CONDITIONS
Official Title
A Study to Investigate Safety and Clinical Activity of Belantamab Mafodotin in Combination With Lenalidomide, Dexamethasone and Nirogacestat in Patients With Transplant Ineligible Newly Diagnosed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be older than 18 years
- Monoclonal plasma cells in bone marrow ≥10% or biopsy proven plasmacytoma with documented multiple myeloma meeting CRAB or malignancy biomarker criteria
- Measurable disease with urine M-protein ≥200 mg/24 hrs, or serum M-protein ≥0.5 g/dL, or serum free light chain level ≥10 mg/dL with abnormal ratio
- Not eligible for high-dose chemotherapy with stem cell transplant due to comorbid conditions or frailty score 1 or 2
- ECOG performance status of 0 to 2
- Adequate organ function by laboratory tests including neutrophil count, hemoglobin, platelets, liver and kidney function
- Female participants not pregnant or breastfeeding and using appropriate contraception if of childbearing potential
- Male participants agreeing to contraception and sperm donation restrictions
- Able to understand study procedures and provide written informed consent
You will not qualify if you...
- Prior systemic therapy for multiple myeloma or smoldering multiple myeloma (except short steroid courses)
- Peripheral neuropathy or neuropathic pain grade 2 or higher
- Major surgery within 2 weeks before study drug start unless clinically stable
- Active renal conditions affecting safety (excluding isolated proteinuria)
- Serious or unstable medical or psychiatric disorders interfering with safety or consent
- Active uncontrolled bleeding or liver disease (except stable chronic liver disease)
- Previous or concurrent cancers other than certain stable types
- Significant cardiovascular risks including recent heart attack or severe heart failure
- Uncontrolled hypertension or active infection requiring treatment
- Known HIV infection without stable control
- Positive hepatitis B or active hepatitis C infection unless treated
- Current corneal epithelial disease except mild punctate keratopathy
- Intolerance to antiviral or antithrombotic prophylaxis
- AL amyloidosis, active POEMS syndrome, or plasma cell leukemia
- Central nervous system involvement by multiple myeloma
- Hypersensitivity to study drugs
- Use of investigational drugs within 14 days or plasmapheresis within 7 days
- Active uncontrolled intestinal or skin disease
- Conditions causing refractory low phosphate, potassium, or magnesium
- Prior gamma secretase inhibitor use
- Use of strong/moderate CYP3A4 inhibitors or inducers
- Recent live or live-attenuated vaccine within 30 days
- Use of contact lenses during treatment
- Failure to adhere to lenalidomide pregnancy prevention program
AI-Screening
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Trial Site Locations
Total: 2 locations
1
General Hospital of Athens "Alexandra", NKUA, Therapeutic Clinic
Athens, Greece, 11528
Actively Recruiting
2
Anticancer Hospital of Thessaloniki "Theageneio"
Thessaloniki, Greece, 54639
Not Yet Recruiting
Research Team
M
Maria Pagoni, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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