Blmf, Lenalidomide and Dexamethasone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma

Sponsor
Hellenic Society of Hematology
Study ID
NCT04808037
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Belantamab mafodotin — DRUG
    Belantamab mafodotin in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed Multiple Myeloma transplant-ineligible

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 lenalidomide and dexamethasone.

Key Dates

Start date
Feb 22, 2021
Status verified
Oct 2023
Primary completion
Sep 8, 2028
Completion
Nov 8, 2028

Study Design

Enrollment
66 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1, First Part
    12 patients are anticipated to receive Belantamab Mafodotin 2.5 Q8W = 2.5 mg/kg on Day 1 of every other 28-day cycle, in combination with Lenalidomide and Dexamethasone
  • Experimental: Cohort 2, First Part
    12 patients are anticipated to receive Belantamab Mafodotin 1.9 Q8W = 1.9 mg/kg on Day 1 of every other 28-day cycle, in combination with Lenalidomide and Dexamethasone
  • Experimental: Cohort 3, First Part
    12 patients are anticipated to receive Belantamab Mafodotin 1.4 Q8W = 1.4 mg/kg on Day 1 of every other 28-day cycle, in combination with Lenalidomide and Dexamethasone
  • Experimental: Group A, Second Part
    15 patients are anticipated to receive Belantamab Mafodotin in the Recommended Phase 2 Dose, in combination with Lenalidomide and Dexamethasone. In this Arm the ocular toxicity will be graded according to the Dose Modification Guidelines for Corneal-Related Adverse Events Associated with belantamab mafodotin
  • Experimental: Group B, Second Part
    15 patients are anticipated to receive Belantamab Mafodotin in the Recommended Phase 2 Dose, in combination with Lenalidomide and Dexamethasone. In this Arm the ocular toxicity will be graded according to the Dose modification guidance based on visual acuity

Primary Outcome Measure

Number of participants with dose-limiting toxicities (DLTs) in each of the cohorts 1-3 [ Time Frame: Five (5) years after last participant randomization ]

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