A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Pomalidomide and Dexamethasone in Patients With Relapsed/ Refractory Multiple Myeloma Previously Treated With One Line Therapy Who Are Lenalidomide Refractory

Sponsor
Hellenic Society of Hematology
Study ID
NCT05581875
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Blood Protein Disorders
  • Corneal Disease
  • Gammopathy, Monoclonal
  • Haematologic Disease
  • Multiple Myeloma
  • Multiple Myeloma in Relapse
  • 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.
  • Pomalidomide — DRUG
    Pomalidomide 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, single-center study designed to assess the safety and preliminary clinical activity of different belantamab mafodotin doses in combination with daratumumab, pomalidomide, and dexamethasone (DPd) in patients with Relapsed/ Refractory Multiple Myeloma (RRMM) previously treated with one line of therapy who are lenalidomide refractory. This will be a 2-Part study. Part 1 will evaluate the safety of belantamab mafodotin in combination with DPd in 2 cohorts and determine the Recommended Phase 2 Dose (RP2D). 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 will further evaluate the safety and assess the preliminary clinical activity of the belantamab mafodotin RP2D in combination with DPd. Overall, approximately 48 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
Oct 20, 2022
Status verified
Oct 2022
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

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

Arms

  • Experimental: Part 1 : Dose finding
    Belantamab mafodotin will be administered by intravenous infusion as a combination therapy as a calculated dose on Day 1 of every other 28-day cycle. Belantamab mafodotin starting dose for Part 1: * Cohort 1: 1.4 Q8W = 1.4 mg/kg on Day 1 of every other 28-day cycle * Cohort 2: 1.9 Q8W = 1.9 mg/kg on Day 1 of every other 28-day cycle Daratumumab 1800mg SC (fixed dose) on: Cycles 1-2: days 1, 8, 15, 22 Cycles 3-6: days 1, 15 Cycles 7+: day 1 Pomalidomide: 4 mg/d on days 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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