Clinical Trial

Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide

Active, Not Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
This is a phase I-II open-label, multicenter, non-randomized study aiming to evaluate the efficacy and safety of belantamab mafodotin in combination with carfilzomib (Kyprolis®) and dexamethasone (Kd). Since this is the first time that this combination is being evaluated in a clinical trial, a first dose escalation part will be developed following the classic 3+3 design, to establish the maximum tolerated dose (MTD) of the combination. Once the MTD will be defined, a dose expansion phase will be open to recruit up to 60 patients. Patients will receive treatment with belantamab-mafodotin + Kd, until unacceptable toxicity, disease progression, patient withdrawal, loss to follow-up, end of study, or death.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-09-28; most recent amendment 2026-05-06.
Status change: Recruiting → Active, Not Recruiting 2026-05-06
Status change: Not Yet Recruiting → Recruiting 2021-11-30
Trial Details
NCT Number NCT05060627
Lead Sponsor PETHEMA Foundation
Collaborators: Adknoma Health Research
Conditions Relapsed Multiple Myeloma
Enrollment 60 participants
Start Date 2021-12-20
Primary Completion 2024-10-23 (estimated)
Study Completion 2028-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-11