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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

belantamab Kd

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

 
 

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

 

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