Retrospective Study of the Use of Belantamab Mafodotin (Blenrep®) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) in Spain.

Last updated: August 2, 2022
Sponsor: PETHEMA Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Lymphoproliferative Disorders

Cancer/tumors

Treatment

N/A

Clinical Study ID

NCT05297240
GEM-RELAMAB
  • All Genders

Study Summary

The proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with RRMM included in the compassionate use or in the expanded access program in Spain between November 2019 and June 2021.

The focus of the study will be on the estimation of the magnitude of the treatment effect as assessed by the overall response rate (ORR), duration of response (DOR), progression free survival (PFS), overall survival (OS), and the safety of single agent belantamab mafodotin in patients with RRMM.

Subjects may receive treatment until progression. Myeloma disease status will be evaluated locally for response and progression per International Myeloma Working Group (IMWG) criteria from cycle 1 day 1 until confirmed progressive disease, death, unacceptable toxicity, or lost to follow-up (whichever occurs first).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Reception of at least one dose of belantamab mafodotin as part of the compassionate use or the expanded access program in Spain between November 2019 and June 2021

Study Design

Total Participants: 170
Study Start date:
March 24, 2022
Estimated Completion Date:
December 31, 2022

Study Description

The proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with RRMM included in the compassionate use or in the expanded access program in Spain between November 2019 and June 2021.

Subjects may receive treatment until progression. Myeloma disease status will be evaluated locally for response and progression per International Myeloma Working Group (IMWG) criteria from cycle 1 day 1 until confirmed progressive disease, death, unacceptable toxicity, or lost to follow-up (whichever occurs first).

The study has the following objectives:

Primary objective

  • The primary objective of this study is to evaluate the efficacy of belantamab mafodotin in terms of overall response, and the different response categories when administered as a single agent in patients with RRMM.

Secondary objectives:

  • Describe the safety and tolerability of single-agent belantamab mafodotin.

  • The overall incidence of ophthalmologic complications.

  • Estimate duration of response (DOR).

  • Estimate time to response (TTR).

  • Estimate time to next treatment (TTNT).

  • Estimate progression-free survival (PFS) and overall survival (OS).

  • Type of treatment administered after single-agent belantamab mafodotin and estimate PFS2.

Connect with a study center

  • H. Universitario de Albacete

    Albacete,
    Spain

    Active - Recruiting

  • H. Doctor José Molina Orosa

    Arrecife,
    Spain

    Active - Recruiting

  • H. San Agustín

    Avilés,
    Spain

    Active - Recruiting

  • H. Clinic de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • H. Moises Broggi

    Barcelona,
    Spain

    Active - Recruiting

  • H. Vall d' Hebron

    Barcelona,
    Spain

    Active - Recruiting

  • H. Basurto

    Bilbao,
    Spain

    Active - Recruiting

  • H. Cruces

    Bilbao,
    Spain

    Active - Recruiting

  • H. Calahorra

    Calahorra,
    Spain

    Active - Recruiting

  • H. Reina Sofía

    Córdoba,
    Spain

    Active - Recruiting

  • H. General Elche

    Elche,
    Spain

    Active - Recruiting

  • H. Fuenlabrada

    Fuenlabrada,
    Spain

    Active - Recruiting

  • H. Galdakao

    Galdakao,
    Spain

    Active - Recruiting

  • H. Francisco de Borja

    Gandia,
    Spain

    Active - Recruiting

  • ICO Girona

    Girona,
    Spain

    Active - Recruiting

  • H. Un. Virgen de las Nieves

    Granada,
    Spain

    Active - Recruiting

  • H. Un. Guadalajara

    Guadalajara,
    Spain

    Active - Recruiting

  • H. Juan Ramón Jiménez

    Huelva,
    Spain

    Active - Recruiting

  • H. Universitario de Jaén

    Jaén,
    Spain

    Active - Recruiting

  • H. Un. Doctor Negrín

    Las Palmas De Gran Canaria,
    Spain

    Active - Recruiting

  • H. Severo Ochoa

    Leganés,
    Spain

    Active - Recruiting

  • H. León

    León,
    Spain

    Active - Recruiting

  • H. San Pedro

    Logroño,
    Spain

    Active - Recruiting

  • H. Un. Lucus Augusti

    Lugo,
    Spain

    Active - Recruiting

  • Fundación Jiménez Díaz

    Madrid,
    Spain

    Active - Recruiting

  • H. Gregorio Marañón

    Madrid,
    Spain

    Active - Recruiting

  • H. Moncloa

    Madrid,
    Spain

    Active - Recruiting

  • H. Ruber Juan Bravo

    Madrid,
    Spain

    Active - Recruiting

  • H. Un. Doce de Octubre

    Madrid,
    Spain

    Active - Recruiting

  • H. Un. Infanta Sofía

    Madrid,
    Spain

    Active - Recruiting

  • H. Un. La Paz

    Madrid,
    Spain

    Active - Recruiting

  • H. Un. La Princesa

    Madrid,
    Spain

    Active - Recruiting

  • H. Un. Puerta del Hierro

    Madrid,
    Spain

    Active - Recruiting

  • H. Un. Quirón Salud

    Madrid,
    Spain

    Active - Recruiting

  • H.M. Sanchinarro

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Clínico San Carlos

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Henares

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • H. Morales Meseguer

    Murcia,
    Spain

    Active - Recruiting

  • H. Un. Virgen de la Arrixaca

    Murcia,
    Spain

    Active - Recruiting

  • H. Virgen de la Victoria

    Málaga,
    Spain

    Active - Recruiting

  • H. Rey Juan Carlos

    Móstoles,
    Spain

    Active - Recruiting

  • H. Universitario Central Asturias

    Oviedo,
    Spain

    Active - Recruiting

  • H. Son Llatzer

    Palma De Mallorca,
    Spain

    Active - Recruiting

  • H. Un. Son Espases

    Palma De Mallorca,
    Spain

    Active - Recruiting

  • H. Montecelo

    Pontevedra,
    Spain

    Active - Recruiting

  • H. Un. Salamanca

    Salamanca,
    Spain

    Active - Recruiting

  • H. Un. Canarias

    Santa Cruz De Tenerife,
    Spain

    Active - Recruiting

  • H. Un. Marqués de Valdecilla

    Santander,
    Spain

    Active - Recruiting

  • H. General Segovia

    Segovia,
    Spain

    Active - Recruiting

  • H. Un. Virgen de Valme

    Sevilla,
    Spain

    Active - Recruiting

  • H. Virgen del Rocío

    Sevilla,
    Spain

    Active - Recruiting

  • H. Mutua Terrasa

    Terrassa,
    Spain

    Active - Recruiting

  • H. Ntra. Señora del Prado

    Toledo,
    Spain

    Active - Recruiting

  • H. Un. Torrejón

    Torrejón De Ardoz,
    Spain

    Active - Recruiting

  • H. Un. Dr. Peset

    Valencia,
    Spain

    Active - Recruiting

  • H. Universitario de la Fe

    Valencia,
    Spain

    Active - Recruiting

  • H. Universitario de Valladolid

    Valladolid,
    Spain

    Active - Recruiting

  • H. Clinico Un. Lozano Blesa

    Zaragoza,
    Spain

    Active - Recruiting

  • H. Miguel Servet

    Zaragoza,
    Spain

    Active - Recruiting

  • H. Royo Villanova

    Zaragoza,
    Spain

    Active - Recruiting

  • H. Ntra. Señora Sonsoles

    Ávila,
    Spain

    Active - Recruiting

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