Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide
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.
PETHEMA Foundation
60 participants
Dec 20, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
In phase 1: * Dose level -1: Belantamab-Mafodotin 1.9 mg/kg day 1, Q8W * Dose level 1,2,3: Belantamab-Mafodotin 2.5 mg/kg day 1, Q8W In phase 2: maximum tolerated dose (MTD) of the combination
In phase 1: * Dose level -1, 1: Carfilzomib 20/45 mg/m2 days 1, 8, and 15, Q4W. * Dose level 2: Carfilzomib 20/56 mg/m2 on days 1, 8, and 15, Q4W * Dose level 3: Carfilzomib 20/70 mg/m2 on days 1, 8, and 15, Q4W. In phase 2: maximum tolerated dose (MTD) of the combination
Description: Dexamethasone 40 mg weekly (days 1, 8, 15 and 22) or 20 mg in patients \> 75 years old., Q4W
Locations(15)
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NCT05060627