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

ConditionsMultiple Myeloma Multiple Myeloma in Relapse Neoplasms Gammopathy, Monoclonal Paraproteinemias Blood Protein Disorders Haematologic Disease Corneal Disease Neoplasms, Plasma Cell

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorHellenic Society of Hematology

About this trial

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.

Eligibility criteria

Qualifiers

Participant must be ≥18 years or older.

Documented diagnosis of Multiple Myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.

Urine M-protein excretion ≥200 mg/24 hrs (≥0.2 g/24 hrs), or

Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or

Disqualifiers

Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute, Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 5.

Major surgery within 4 weeks before the first dose of study drug

NOTE 1: participant must be clinically stable following a major surgery to be entered in the study.

NOTE 2: major surgery shall be defined based on the Investigator's judgment according to the extent and complexity of the procedure, its pathophysiological consequences and consecutive clinical outcomes.

Trial design

Treatments tested in this trial

Belantamab Mafodotin-Blmf
Daratumumab
Pomalidomide
Dexamethasone

Treatment groups

48 Participants

are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Hellenic Society of Hematology

Lead sponsor

GlaxoSmithKline

Collaborator

Source ClinicalTrials.gov