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

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

Trial Details

NCT ID
NCT05573802
Phase
PHASE1 / PHASE2
Sponsor
Hellenic Society of Hematology
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • Belantamab Mafodotin-Blmf
  • Lenalidomide
  • Dexamethasone
  • Nirogacestat
Locations (sample)
  • Athens, Greece|37.98376,23.72784
  • Thessaloniki, Greece|40.64072,22.93493

Key Eligibility Criteria

  • Participant must be \>18 years of age
  • Monoclonal plasma cells in the bone marrow (BM) ≥10% or presence of a biopsy proven plasmacytoma and documented Multiple Myeloma (MM) satisfying at…
  • CRAB criteria:
  • i. Hypercalcemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than upper limit of normal (ULN) or \>2.75 mmol/L (\>11 mg/dL).

For full eligibility, visit ClinicalTrials.gov.

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