A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Transplant Ineligible

Sponsor
Hellenic Society of Hematology
Study ID
NCT05280275
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Blood Protein Disorders
  • Corneal Disease
  • Gammopathy, Monoclonal
  • Haematologic Disease
  • Multiple Myeloma
  • Neoplasms
  • Neoplasms, Plasma Cell
  • Paraproteinemias

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belantamab Mafodotin-Blmf — DRUG
    Blmf will be available as 100 mg/vial in single-use vial for reconstitution, supplied as lyophilized powder. Blmf will be delivered as IV solution over at least 30 minutes.
  • Daratumumab — DRUG
    Daratumumab will be administered with subcutaneous injections. On days where Blmf is given together with daratumumab, daratumumab should be performed first.
  • Lenalidomide — DRUG
    Lenalidomide will be administered per os.
  • Dexamethasone — DRUG
    Dexamethasone will be administered intravenously or per os.

Study Details

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 daratumumab, lenalidomide and dexamethasone. The study will evaluate different doses of belantamab mafodotin in combination with daratumumab, lenalidomide and dexamethasone in 2 cohorts 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 for future studies in the transplant ineligible newly diagnosed multiple myeloma setting. Overall, approximately 36 participants will be enrolled in the study. Participant follow-up will continue up to 3 years after the last participant is randomized. The estimated accrual period will be 12 months corresponding to an approximate total study duration of 4 years.

Key Dates

Start date
Apr 13, 2022
Status verified
Nov 2023
Primary completion
Mar 15, 2026
Completion
Mar 15, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Finding
    Belantamab mafodotin will be administered as a combination therapy as a calculated dose on Day 1 of every other 28-day cycle. Belantamab mafodotin starting dose: 1. Cohort 1: 1.9 Q8W = 1.9 mg/kg on Day 1 of every other 28-day cycle 2. Cohort 2: 1.4 Q8W = 1.4 mg/kg on Day 1 of every other 28-day cycle Administration schedule for daratumumab 1800mg SC (fixed dose): Cycles 1-2: days 1, 8, 15, 22 Cycles 3-6: days 1, 15 Cycles 7+: day 1 Lenalidomide: 25 mg/d on day 1-21 of every 28-day cycle. Dexamethasone: 40 mg/d on days 1, 8, 15, 22 of every 28-day cycle in participants \< 75 years; 20 mg/d on days 1, 8, 15, 22 of every 28-day cycle in participants ≥ 75 years

Primary Outcome Measure

Part 1: Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 28 days ]

Central Contacts

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