- Recruiting
NCT05060627: Phase 1/2: Belantamab Mafodotin + Kd RRMM Multiple Myeloma, Refractory to Lenalidomide
Updated: Sep 19, 2022
NCT05060627: An Open Label, Multicenter, Phase I/II Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide
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.
Sponsor
Collaborator
Adknoma Health Research
ClinicalTrials.gov Identifier: NCT05060627
Official Title: An Open Label, Multicenter, Phase I/II Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide.
First Posted : September 29, 2021
Click here to see details on ClinicalTrials.gov
Belantamab mafodotin : National Cancer Institute
Belantamab mafodotin : MedlinePlus Drug Information
Drug: Belantamab mafodotin
Drug: Carfilzomib
Drug: Dexamethasone
Investigators
Study Chair: Paula Rodríguez Otero Clínica Universidad de Navarra
Study Chair: María-Victoria Mateos University of Salamanca
Study Chair: Jesús San Miguel Izquierdo Clínica Universidad de Navarra
Location
Spain
Spanish Myeloma Group (GEM-PETHEMA) Posts
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NCT00461747: Phase 3 - GEM05 for Patients With Multiple Myeloma Under 65 Years (GEM05MENOS65)
NCT01916252: Phase 3 - Bortezomib, Lenalidomide & IV Busulfan Under 65 - (GEM2012MENOS65) PETHEMA
NCT02406144: Phase 3 - Maint. Lenalidomide, Dex VS Lenalidomide, Dex. & MLN9708 After ASCT NDMM
NCT02415413: Phase 2 - Carfilzomib in Patients Under 65 With High Risk Smoldering MM (GEM-CESAR trial)
NCT03336073: Phase 2: GEM-KyCyDex - Carfilzomib, Cyclophosphamide, Dexamethasone in Multiple Myeloma
NCT04802356: Phase 2: Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma