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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05297240
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

PETHEMA Foundation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Javier de la RubiaAdrián AlegreMaría Victoria Mateos
Principal Investigator Affiliation HOSPITAL LA FE VALENCIAHospital La Princesa (Madrid)Hospital Clínico, Salamanca
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

H. Universitario de Albacete, Albacete, Spain

Status

Recruiting

Address

H. Universitario de Albacete

Albacete, ,

Site Contact

Juan Ramón Romero Macías

carmen@fundacionpethema.es

0034 699 835 437

H. Doctor José Molina Orosa, Arrecife, Spain

Status

Recruiting

Address

H. Doctor José Molina Orosa

Arrecife, ,

Site Contact

Víctor Alfonso Ferrandez

carmen@fundacionpethema.es

0034 699 835 437

H. San Agustín, Avilés, Spain

Status

Recruiting

Address

H. San Agustín

Avilés, ,

Site Contact

Walter Javier Zambrano

carmen@fundacionpethema.es

0034 699 835 437

H. Clinic de Barcelona, Barcelona, Spain

Status

Recruiting

Address

H. Clinic de Barcelona

Barcelona, ,

Site Contact

Ana Triguero

carmen@fundacionpethema.es

0034 699 835 437

H. Moises Broggi, Barcelona, Spain

Status

Recruiting

Address

H. Moises Broggi

Barcelona, ,

Site Contact

María Elena María Elena Cabezudo/Gabriela Bustamante

carmen@fundacionpethema.es

0034 699 835 437

H. Vall d' Hebron, Barcelona, Spain

Status

Recruiting

Address

H. Vall d' Hebron

Barcelona, ,

Site Contact

Mercedes Gironella

carmen@fundacionpethema.es

0034 699 835 437

H. Basurto, Bilbao, Spain

Status

Recruiting

Address

H. Basurto

Bilbao, ,

Site Contact

José Antonio Márquez

carmen@fundacionpethema.es

0034 699 835 437

H. Cruces, Bilbao, Spain

Status

Recruiting

Address

H. Cruces

Bilbao, ,

Site Contact

Xavier Martín

carmen@fundacionpethema.es

0034 699 835 437

H. Calahorra, Calahorra, Spain

Status

Recruiting

Address

H. Calahorra

Calahorra, ,

Site Contact

Estefanía Ruiz

carmen@fundacionpethema.es

0034 699 835 437

H. Reina Sofía, Córdoba, Spain

Status

Recruiting

Address

H. Reina Sofía

Córdoba, ,

Site Contact

Margarita Fernández de la Mata

carmen@fundacionpethema.es

0034 699 835 437

H. General Elche, Elche, Spain

Status

Recruiting

Address

H. General Elche

Elche, ,

Site Contact

Venancio Conesa

carmen@fundacionpethema.es

0034 699 835 437

H. Fuenlabrada, Fuenlabrada, Spain

Status

Recruiting

Address

H. Fuenlabrada

Fuenlabrada, ,

Site Contact

Amaia López

carmen@fundacionpethema.es

0034 699 835 437

H. Galdakao, Galdakao, Spain

Status

Recruiting

Address

H. Galdakao

Galdakao, ,

Site Contact

Eukene Gainza

carmen@fundacionpethema.es

0034 699 835 437

H. Francisco de Borja, Gandia, Spain

Status

Recruiting

Address

H. Francisco de Borja

Gandia, ,

Site Contact

María Ángeles Ruiz

carmen@fundacionpethema.es

0034 699 835 437

ICO Girona, Girona, Spain

Status

Recruiting

Address

ICO Girona

Girona, ,

Site Contact

Yolanda González

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Virgen de las Nieves, Granada, Spain

Status

Recruiting

Address

H. Un. Virgen de las Nieves

Granada, ,

Site Contact

Esther Clavero

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Guadalajara, Guadalajara, Spain

Status

Recruiting

Address

H. Un. Guadalajara

Guadalajara, ,

Site Contact

Alejandro Vázquez Ramo

carmen@fundacionpethema.es

0034 699 835 437

H. Juan Ramón Jiménez, Huelva, Spain

Status

Recruiting

Address

H. Juan Ramón Jiménez

Huelva, ,

Site Contact

Juan Francisco Domínguez

carmen@fundacionpethema.es

0034 699 835 437

H. Universitario de Jaén, Jaén, Spain

Status

Recruiting

Address

H. Universitario de Jaén

Jaén, ,

Site Contact

Magdalena Anguita

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Doctor Negrín, Las Palmas De Gran Canaria, Spain

Status

Recruiting

Address

H. Un. Doctor Negrín

Las Palmas De Gran Canaria, ,

Site Contact

Alexia Alexia Suarez Cabrera

carmen@fundacionpethema.es

0034 699 835 437

H. Severo Ochoa, Leganés, Spain

Status

Recruiting

Address

H. Severo Ochoa

Leganés, ,

Site Contact

Rosalía Riaza

carmen@fundacionpethema.es

0034 699 835 437

H. León, León, Spain

Status

Recruiting

Address

H. León

León, ,

Site Contact

Fernando Escalante

carmen@fundacionpethema.es

0034 699 835 437

H. San Pedro, Logroño, Spain

Status

Recruiting

Address

H. San Pedro

Logroño, ,

Site Contact

Montserrat Hernández

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Lucus Augusti, Lugo, Spain

Status

Recruiting

Address

H. Un. Lucus Augusti

Lugo, ,

Site Contact

Esperanza Lavilla

carmen@fundacionpethema.es

0034 699 835 437

Fundación Jiménez Díaz, Madrid, Spain

Status

Recruiting

Address

Fundación Jiménez Díaz

Madrid, ,

Site Contact

Elena Prieto

carmen@fundacionpethema.es

0034 699 835 437

H. Gregorio Marañón, Madrid, Spain

Status

Recruiting

Address

H. Gregorio Marañón

Madrid, ,

Site Contact

Cristina Encinas

carmen@fundacionpethema.es

0034 699 835 437

H. Moncloa, Madrid, Spain

Status

Recruiting

Address

H. Moncloa

Madrid, ,

Site Contact

Concha Alaez Usón

carmen@fundacionpethema.es

0034 699 835 437

H. Ruber Juan Bravo, Madrid, Spain

Status

Recruiting

Address

H. Ruber Juan Bravo

Madrid, ,

Site Contact

Aranzazu Alonso Alonso

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Doce de Octubre, Madrid, Spain

Status

Recruiting

Address

H. Un. Doce de Octubre

Madrid, ,

Site Contact

Joaquin Martínez

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Infanta Sofía, Madrid, Spain

Status

Recruiting

Address

H. Un. Infanta Sofía

Madrid, ,

Site Contact

Eugenio Giménez

carmen@fundacionpethema.es

0034 699 835 437

H. Un. La Paz, Madrid, Spain

Status

Recruiting

Address

H. Un. La Paz

Madrid, ,

Site Contact

Ana López de la Guía

carmen@fundacionpethema.es

0034 699 835 437

H. Un. La Princesa, Madrid, Spain

Status

Recruiting

Address

H. Un. La Princesa

Madrid, ,

Site Contact

Gonzalo Benzo

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Puerta del Hierro, Madrid, Spain

Status

Recruiting

Address

H. Un. Puerta del Hierro

Madrid, ,

Site Contact

Rafael Ríos Tamayo

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Quirón Salud, Madrid, Spain

Status

Recruiting

Address

H. Un. Quirón Salud

Madrid, ,

Site Contact

Carmen Martínez Chamorro

carmen@fundacionpethema.es

0034 699 835 437

H.M. Sanchinarro, Madrid, Spain

Status

Recruiting

Address

H.M. Sanchinarro

Madrid, ,

Site Contact

Laura Llorente

carmen@fundacionpethema.es

0034 699 835 437

Hospital Clínico San Carlos, Madrid, Spain

Status

Recruiting

Address

Hospital Clínico San Carlos

Madrid, ,

Site Contact

Cristina Pérez

carmen@fundacionpethema.es

0034 699 835 437

Hospital Universitario Henares, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Henares

Madrid, ,

Site Contact

Cristina Muñoz

carmen@fundacionpethema.es

0034 699 835 437

Hospital Universitario Ramón y Cajal, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Ramón y Cajal

Madrid, ,

Site Contact

Maria Jesús Blanchard

carmen@fundacionpethema.es

0034 699 835 437

H. Morales Meseguer, Murcia, Spain

Status

Recruiting

Address

H. Morales Meseguer

Murcia, ,

Site Contact

Felipe de Arriba

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Virgen de la Arrixaca, Murcia, Spain

Status

Recruiting

Address

H. Un. Virgen de la Arrixaca

Murcia, ,

Site Contact

Valentín Cabañas

carmen@fundacionpethema.es

0034 699 835 437

H. Virgen de la Victoria, Málaga, Spain

Status

Recruiting

Address

H. Virgen de la Victoria

Málaga, ,

Site Contact

Ricarda García

carmen@fundacionpethema.es

0034 699 835 437

H. Rey Juan Carlos, Móstoles, Spain

Status

Recruiting

Address

H. Rey Juan Carlos

Móstoles, ,

Site Contact

Alberto Eterio Velasco

carmen@fundacionpethema.es

0034 699 835 437

H. Universitario Central Asturias, Oviedo, Spain

Status

Recruiting

Address

H. Universitario Central Asturias

Oviedo, ,

Site Contact

Ángel Ramirez Payer

carmen@fundacionpethema.es

0034 699 835 437

H. Son Llatzer, Palma De Mallorca, Spain

Status

Recruiting

Address

H. Son Llatzer

Palma De Mallorca, ,

Site Contact

Raquel del Campo García

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Son Espases, Palma De Mallorca, Spain

Status

Recruiting

Address

H. Un. Son Espases

Palma De Mallorca, ,

Site Contact

José María Sánchez Raga

carmen@fundacionpethema.es

0034 699 835 437

H. Montecelo, Pontevedra, Spain

Status

Recruiting

Address

H. Montecelo

Pontevedra, ,

Site Contact

Ana Maria Dios Loureiro

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Salamanca, Salamanca, Spain

Status

Recruiting

Address

H. Un. Salamanca

Salamanca, ,

Site Contact

Ramón García Sanz

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Canarias, Santa Cruz De Tenerife, Spain

Status

Recruiting

Address

H. Un. Canarias

Santa Cruz De Tenerife, ,

Site Contact

Álvaro Bienert García

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Marqués de Valdecilla, Santander, Spain

Status

Recruiting

Address

H. Un. Marqués de Valdecilla

Santander, ,

Site Contact

Maria Aranzazu Bermúdez

carmen@fundacionpethema.es

0034 699 835 437

H. General Segovia, Segovia, Spain

Status

Recruiting

Address

H. General Segovia

Segovia, ,

Site Contact

Aranzazu García

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Virgen de Valme, Sevilla, Spain

Status

Recruiting

Address

H. Un. Virgen de Valme

Sevilla, ,

Site Contact

Eduardo Ríos

carmen@fundacionpethema.es

0034 699 835 437

H. Virgen del Rocío, Sevilla, Spain

Status

Recruiting

Address

H. Virgen del Rocío

Sevilla, ,

Site Contact

Estrella Carrillo

carmen@fundacionpethema.es

0034 699 835 437

H. Mutua Terrasa, Terrassa, Spain

Status

Recruiting

Address

H. Mutua Terrasa

Terrassa, ,

Site Contact

Josep Maria Martí

carmen@fundacionpethema.es

0034 699 835 437

H. Ntra. Señora del Prado, Toledo, Spain

Status

Recruiting

Address

H. Ntra. Señora del Prado

Toledo, ,

Site Contact

María Dolores Martínez Moya

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Torrejón, Torrejón De Ardoz, Spain

Status

Recruiting

Address

H. Un. Torrejón

Torrejón De Ardoz, ,

Site Contact

Ana Morales

carmen@fundacionpethema.es

0034 699 835 437

H. Un. Dr. Peset, Valencia, Spain

Status

Recruiting

Address

H. Un. Dr. Peset

Valencia, ,

Site Contact

Ana García Feria

carmen@fundacionpethema.es

0034 699 835 437

H. Universitario de la Fe, Valencia, Spain

Status

Recruiting

Address

H. Universitario de la Fe

Valencia, ,

Site Contact

Rafael Andreu La Piedra

carmen@fundacionpethema.es

0034 699 835 437

H. Universitario de Valladolid, Valladolid, Spain

Status

Recruiting

Address

H. Universitario de Valladolid

Valladolid, ,

Site Contact

Alfonso García de Coca

carmen@fundacionpethema.es

0034 699 835 437

H. Clinico Un. Lozano Blesa, Zaragoza, Spain

Status

Recruiting

Address

H. Clinico Un. Lozano Blesa

Zaragoza, ,

Site Contact

Luis Palomera

carmen@fundacionpethema.es

0034 699 835 437

H. Miguel Servet, Zaragoza, Spain

Status

Recruiting

Address

H. Miguel Servet

Zaragoza, ,

Site Contact

Araceli Rubio

carmen@fundacionpethema.es

0034 699 835 437

H. Royo Villanova, Zaragoza, Spain

Status

Recruiting

Address

H. Royo Villanova

Zaragoza, ,

Site Contact

Vicente Carrasco

carmen@fundacionpethema.es

0034 699 835 437

H. Ntra. Señora Sonsoles, Ávila, Spain

Status

Recruiting

Address

H. Ntra. Señora Sonsoles

Ávila, ,

Site Contact

Abelardo Bárez

carmen@fundacionpethema.es

0034 699 835 437