RecruitingPhase 1Phase 2NCT05060627

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.


Sponsor

PETHEMA Foundation

Enrollment

60 participants

Start Date

Dec 20, 2021

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination — belantamab mafodotin (an antibody-drug conjugate that targets myeloma cells), carfilzomib (a proteasome inhibitor), and dexamethasone — for multiple myeloma patients whose cancer has come back and stopped responding to lenalidomide. **You may be eligible if...** - You have relapsed multiple myeloma and have received 1 to 3 prior lines of treatment - Your cancer is no longer responding to lenalidomide (i.e., it progressed while on it or within 60 days of stopping) - You are willing and able to follow the study schedule **You may NOT be eligible if...** - You have had more than 3 prior lines of therapy - You are refractory to carfilzomib (unless you haven't received it before) - You have severe active infections, uncontrolled disease, or other conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBelantamab mafodotin

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

DRUGCarfilzomib

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

DRUGDexamethasone

Description: Dexamethasone 40 mg weekly (days 1, 8, 15 and 22) or 20 mg in patients \> 75 years old., Q4W


Locations(15)

Hospital Germans Trias i Pujol (ICO BADALONA)

Badalona, Spain

Hospital Clinic

Barcelona, Spain

ICO Hospitalet

Bellvitge, Spain

H. Gregorio Marañón

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

H. Morales Meseguer

Murcia, Spain

HUCA

Oviedo, Spain

H. Son Llatzer

Palma de Mallorca, Spain

Clínica Universidad de Navarra (CUN)

Pamplona, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

H. Universitario de Canarias

Santa Cruz de Tenerife, Spain

H. Universitario Marqués de Valdecilla

Santander, Spain

Complejo Hospitalario Santiago (CHUS)

Santiago de Compostela, Spain

Complejo Hospitalario Virgen del Rocío

Seville, Spain

H.U. La Fe

Valencia, Spain

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NCT05060627


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