Actively Recruiting
Safety and Clinical Activity Study of Belantamab Mafodotin With Lenalidomide, Dexamethasone, and Nirogacestat in Transplant-Ineligible Newly Diagnosed Multiple Myeloma
Led by Hellenic Society of Hematology · Updated on 2023-10-24
36
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hellenic Society of Hematology
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and clinical activity of different doses of belantamab mafodotin combined with lenalidomide, dexamethasone, and nirogacestat in patients with newly diagnosed multiple myeloma who are not able to undergo a transplant. This phase 1/2, open-label study aims to find the recommended dose for future studies and to explore how to manage eye-related side effects. About 36 participants will be enrolled, with follow-up lasting up to 3 to 4 years after enrollment ends. Belantamab mafodotin is given intravenously every other 28-day cycle at doses ranging from 1.0 to 1.9 mg/kg. Lenalidomide is taken orally daily on days 1 to 21 of each 28-day cycle. Dexamethasone is given either orally or intravenously on days 1, 8, 15, and 22 of each cycle, with dose adjustments based on age. Nirogacestat is taken twice daily starting three days before the first dose and on the same days as belantamab mafodotin. The study has two parts: dose finding to establish the best dose, followed by dose expansion with random assignment to different dose modification guidelines for eye side effects. Participants will undergo regular assessments to monitor side effects, including eye exams, and overall response to treatment. Researchers will track dose-limiting toxicities, adverse events, ocular toxicity, and response rates over up to four years. Additional evaluations include measuring drug levels, disease progress, and survival. Participants must provide consent and will be closely monitored throughout the study period, which is expected to last approximately four years in total.
CONDITIONS
Brief 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 over 18 years of age
- Monoclonal plasma cells in bone marrow 10% or more, or biopsy-proven plasmacytoma with documented multiple myeloma meeting CRAB or malignancy biomarker criteria
- Must have measurable disease defined by urine or serum M-protein or serum free light chain levels
- Not eligible for high-dose chemotherapy with stem cell transplant due to significant comorbid conditions
- ECOG Performance Status of 0 to 2
- Adequate organ function based on blood counts, liver, and kidney tests
- Female participants must not be pregnant or breastfeeding and meet specified contraception requirements
- Male participants must agree to contraception and avoid sperm donation during and after treatment
- 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 (emergency steroids allowed)
- Peripheral neuropathy or neuropathic pain Grade 2 or higher
- Major surgery within 2 weeks prior to first study drug dose
- Active renal conditions affecting safety (except isolated proteinuria from myeloma)
- Serious or unstable medical or psychiatric disorders interfering with safety or compliance
- Active uncontrolled bleeding or liver/biliary disease
- Previous or concurrent malignancies except certain treated cancers stable for 2 years
- Significant cardiovascular risks including recent heart attack or severe heart failure
- Uncontrolled hypertension
- Active infections requiring treatment
- Known HIV infection unless well controlled
- Active hepatitis B or C infections unless successfully treated
- Current corneal epithelial disease except mild punctate keratopathy
- Intolerance to antiviral or antithrombotic prophylaxis
- Amyloidosis, active POEMS syndrome, or plasma cell leukemia
- Central nervous system involvement by multiple myeloma
- Hypersensitivity to study drugs or components
- Recent investigational drug use or plasmapheresis
- Active uncontrolled intestinal or skin disease
- Electrolyte imbalances not manageable by replacement
- Prior gamma secretase inhibitor treatment
- Use of strong or moderate CYP3A4 inhibitors or inducers
- Receipt of live vaccines within 30 days before study drug
- Use of contact lenses during treatment
- Non-adherence to lenalidomide pregnancy prevention program
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 or discontinuation
Participants receive combination therapy with Belantamab Mafodotin, Lenalidomide, Dexamethasone, and Nirogacestat. Belantamab Mafodotin is administered intravenously on Day 1 of every other 28-day cycle. Lenalidomide is taken orally on days 1-21 of each 28-day cycle. Dexamethasone is given intravenously or orally on days 1, 8, 15, and 22 of each 28-day cycle. Nirogacestat is taken twice daily starting three days before Belantamab Mafodotin and continues on days when Belantamab Mafodotin is administered.
Visits every 2 weeks corresponding to treatment cycles
Duration - Up to 4 years
Participants are monitored for adverse events, ocular toxicity, response to treatment, and survival outcomes for up to 4 years after treatment.
Periodic visits as scheduled for safety and efficacy assessments
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
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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