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

August 2, 2022 updated by: PETHEMA Foundation

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Albacete, Spain
        • Recruiting
        • H. Universitario de Albacete
        • Contact:
          • Juan Ramón Romero Macías
        • Principal Investigator:
          • Juan Ramón Romero Macías
        • Principal Investigator:
          • Ángela Ibañez
      • Arrecife, Spain
        • Recruiting
        • H. Doctor José Molina Orosa
        • Contact:
          • Víctor Alfonso Ferrandez
        • Principal Investigator:
          • Víctor Alfonso Ferrandez
      • Avilés, Spain
        • Recruiting
        • H. San Agustín
        • Contact:
          • Walter Javier Zambrano
        • Principal Investigator:
          • Walter Javier Zambrano
      • Barcelona, Spain
        • Recruiting
        • H. Clinic de Barcelona
        • Contact:
          • Ana Triguero
        • Principal Investigator:
          • Ana Triguero
      • Barcelona, Spain
        • Recruiting
        • H. Moises Broggi
        • Contact:
          • María Elena María Elena Cabezudo/Gabriela Bustamante
        • Principal Investigator:
          • María Elena Cabezudo
        • Principal Investigator:
          • Gabriela Bustamante
      • Barcelona, Spain
        • Recruiting
        • H. Vall d' Hebron
        • Contact:
          • Mercedes Gironella
        • Principal Investigator:
          • Mercedes Gironella
      • Bilbao, Spain
        • Recruiting
        • H. Basurto
        • Contact:
          • José Antonio Márquez
        • Principal Investigator:
          • José Antonio Márquez
      • Bilbao, Spain
        • Recruiting
        • H. Cruces
        • Contact:
          • Xavier Martín
        • Principal Investigator:
          • Xavier Martín
      • Calahorra, Spain
        • Recruiting
        • H. Calahorra
        • Contact:
          • Estefanía Ruiz
        • Principal Investigator:
          • Estefanía Ruiz
      • Córdoba, Spain
        • Recruiting
        • H. Reina Sofia
        • Contact:
          • Margarita Fernández de la Mata
        • Principal Investigator:
          • Margarita Fernández de la Mata
      • Elche, Spain
        • Recruiting
        • H. General Elche
        • Contact:
          • Venancio Conesa
        • Principal Investigator:
          • Venancio Conesa
      • Fuenlabrada, Spain
        • Recruiting
        • H. Fuenlabrada
        • Contact:
          • Amaia López
        • Principal Investigator:
          • Amaia López
      • Galdakao, Spain
        • Recruiting
        • H. Galdakao
        • Contact:
          • Eukene Gainza
        • Principal Investigator:
          • Eukene Gainza
        • Principal Investigator:
          • José Enrique de la Puerta
        • Principal Investigator:
          • Nerea Areizaga
      • Gandia, Spain
        • Recruiting
        • H. Francisco de Borja
        • Contact:
          • María Ángeles Ruiz
        • Principal Investigator:
          • María Ángeles Ruiz
        • Principal Investigator:
          • Cristina Moragues
      • Girona, Spain
        • Recruiting
        • ICO Girona
        • Contact:
          • Yolanda González
        • Principal Investigator:
          • Yolanda González
      • Granada, Spain
        • Recruiting
        • H. Un. Virgen de las Nieves
        • Contact:
          • Esther Clavero
        • Principal Investigator:
          • Esther Clavero
      • Guadalajara, Spain
        • Recruiting
        • H. Un. Guadalajara
        • Contact:
          • Alejandro Vázquez Ramo
        • Principal Investigator:
          • Alejandro Vázquez Ramo
        • Principal Investigator:
          • Beatriz Merchan
      • Huelva, Spain
        • Recruiting
        • H. Juan Ramón Jimenez
        • Contact:
          • Juan Francisco Domínguez
        • Principal Investigator:
          • Juan Francisco Domínguez
      • Jaén, Spain
        • Recruiting
        • H. Universitario de Jaén
        • Contact:
          • Magdalena Anguita
        • Principal Investigator:
          • Magdalena Anguita
      • Las Palmas De Gran Canaria, Spain
        • Recruiting
        • H. Un. Doctor Negrín
        • Principal Investigator:
          • Alexia Suarez Cabrera
        • Contact:
          • Alexia Alexia Suarez Cabrera
        • Principal Investigator:
          • Hugo Luzardo Henriquez
      • Leganés, Spain
        • Recruiting
        • H. Severo Ochoa
        • Contact:
          • Rosalía Riaza
        • Principal Investigator:
          • Rosalía Riaza
      • León, Spain
        • Recruiting
        • H. León
        • Principal Investigator:
          • Fernando Escalante
        • Contact:
          • Fernando Escalante
      • Logroño, Spain
        • Recruiting
        • H. San Pedro
        • Contact:
          • Montserrat Hernández
        • Principal Investigator:
          • Montserrat Hernández
      • Lugo, Spain
        • Recruiting
        • H. Un. Lucus Augusti
        • Principal Investigator:
          • Esperanza Lavilla
        • Contact:
          • Esperanza Lavilla
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
          • Maria Jesús Blanchard
        • Principal Investigator:
          • Maria Jesús Blanchard
      • Madrid, Spain
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Cristina Pérez
        • Principal Investigator:
          • Cristina Pérez
      • Madrid, Spain
        • Recruiting
        • Fundación Jiménez Díaz
        • Principal Investigator:
          • Elham Askari
        • Contact:
          • Elena Prieto
        • Principal Investigator:
          • Elena Prieto
      • Madrid, Spain
        • Recruiting
        • H. Ruber Juan Bravo
        • Principal Investigator:
          • Aránzazu Alonso Alonso
        • Contact:
          • Aranzazu Alonso Alonso
      • Madrid, Spain
        • Recruiting
        • H. Gregorio Maranon
        • Contact:
          • Cristina Encinas
        • Principal Investigator:
          • Cristina Encinas
      • Madrid, Spain
        • Recruiting
        • H. Moncloa
        • Contact:
          • Concha Alaez Usón
        • Principal Investigator:
          • Concha Alaez Usón
      • Madrid, Spain
        • Recruiting
        • H. Un. Doce de Octubre
        • Contact:
          • Joaquin Martínez
        • Principal Investigator:
          • Joaquin Martínez
        • Principal Investigator:
          • Ana Jiménez
        • Principal Investigator:
          • Rafael Alonso
        • Principal Investigator:
          • Melisa Almendra
        • Principal Investigator:
          • Sara Redondo
        • Principal Investigator:
          • Clara Cuellar
      • Madrid, Spain
        • Recruiting
        • H. Un. Infanta Sofía
        • Contact:
          • Eugenio Giménez
        • Principal Investigator:
          • Eugenio Giménez
      • Madrid, Spain
        • Recruiting
        • H. Un. La Paz
        • Principal Investigator:
          • Ana López de la Guía
        • Contact:
          • Ana López de la Guía
      • Madrid, Spain
        • Recruiting
        • H. Un. La Princesa
        • Contact:
          • Gonzalo Benzo
        • Principal Investigator:
          • Gonzalo Benzo
      • Madrid, Spain
        • Recruiting
        • H. Un. Puerta del Hierro
        • Principal Investigator:
          • Rafael Ríos Tamayo
        • Contact:
          • Rafael Ríos Tamayo
      • Madrid, Spain
        • Recruiting
        • H. Un. Quirón Salud
        • Principal Investigator:
          • Carmen Martinez Chamorro
        • Contact:
          • Carmen Martínez Chamorro
      • Madrid, Spain
        • Recruiting
        • H.M. Sanchinarro
        • Contact:
          • Laura Llorente
        • Principal Investigator:
          • Laura Llorente
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Henares
        • Contact:
          • Cristina Muñoz
        • Principal Investigator:
          • Cristina Muñoz
      • Murcia, Spain
        • Recruiting
        • H. Morales Meseguer
        • Contact:
          • Felipe de Arriba
        • Principal Investigator:
          • Felipe de Arriba
      • Murcia, Spain
        • Recruiting
        • H. Un. Virgen de la Arrixaca
        • Contact:
          • Valentín Cabañas
        • Principal Investigator:
          • Valentín Cabañas
      • Málaga, Spain
        • Recruiting
        • H. Virgen de la Victoria
        • Contact:
          • Ricarda García
        • Principal Investigator:
          • Ricarda García
      • Móstoles, Spain
        • Recruiting
        • H. Rey Juan Carlos
        • Contact:
          • Alberto Eterio Velasco
        • Principal Investigator:
          • Alberto Eterio Velasco
      • Oviedo, Spain
        • Recruiting
        • H. Universitario Central Asturias
        • Contact:
          • Ángel Ramirez Payer
      • Palma De Mallorca, Spain
        • Recruiting
        • H. Son Llàtzer
        • Principal Investigator:
          • Joan Bargay
        • Principal Investigator:
          • Antonia Cladera
        • Contact:
          • Raquel del Campo García
        • Principal Investigator:
          • Raquel del Campo García
      • Palma De Mallorca, Spain
        • Recruiting
        • H. Un. Son Espases
        • Principal Investigator:
          • Antonia Sampol
        • Contact:
          • José María Sánchez Raga
        • Principal Investigator:
          • José María Sánchez Raga
      • Pontevedra, Spain
        • Recruiting
        • H. Montecelo
        • Principal Investigator:
          • Ana Maria Dios Loureiro
        • Contact:
          • Ana Maria Dios Loureiro
      • Salamanca, Spain
        • Recruiting
        • H. Un. Salamanca
        • Contact:
          • Ramón García Sanz
        • Principal Investigator:
          • Ramón García Sanz
        • Principal Investigator:
          • María Pilar Leoz
        • Principal Investigator:
          • Beatriz Rey
      • Santa Cruz De Tenerife, Spain
        • Recruiting
        • H. Un. Canarias
        • Contact:
          • Álvaro Bienert García
        • Principal Investigator:
          • Álvaro Bienert García
      • Santander, Spain
        • Recruiting
        • H. Un. Marqués de Valdecilla
        • Principal Investigator:
          • Carmen Montes
        • Contact:
          • Maria Aranzazu Bermúdez
        • Principal Investigator:
          • Maria Aranzazu Bermúdez
      • Segovia, Spain
        • Recruiting
        • H. General Segovia
        • Contact:
          • Aranzazu García
        • Principal Investigator:
          • Aranzazu García
      • Sevilla, Spain
        • Recruiting
        • H. Virgen del Rocio
        • Contact:
          • Estrella Carrillo
        • Principal Investigator:
          • Estrella Carrillo
      • Sevilla, Spain
        • Recruiting
        • H. Un. Virgen de Valme
        • Contact:
          • Eduardo Ríos
        • Principal Investigator:
          • Eduardo Ríos
      • Terrassa, Spain
        • Recruiting
        • H. Mutua Terrasa
        • Contact:
          • Josep Maria Martí
        • Principal Investigator:
          • Josep Maria Martí
      • Toledo, Spain
        • Recruiting
        • H. Ntra. Señora del Prado
        • Contact:
          • María Dolores Martínez Moya
        • Principal Investigator:
          • María Dolores Martínez Moya
      • Torrejón De Ardoz, Spain
        • Recruiting
        • H. Un. Torrejón
        • Contact:
          • Ana Morales
        • Principal Investigator:
          • Ana Morales
      • Valencia, Spain
        • Recruiting
        • H. Un. Dr. Peset
        • Contact:
          • Ana García Feria
        • Principal Investigator:
          • Ana García Feria
        • Principal Investigator:
          • Paz Ribas
      • Valencia, Spain
        • Recruiting
        • H. Universitario de la Fe
        • Contact:
          • Rafael Andreu La Piedra
        • Principal Investigator:
          • Rafael Andreu La Piedra
        • Principal Investigator:
          • Mario Arnao
      • Valladolid, Spain
        • Recruiting
        • H. Universitario de Valladolid
        • Contact:
          • Alfonso García de Coca
        • Principal Investigator:
          • Alfonso García de Coca
      • Zaragoza, Spain
        • Recruiting
        • H. Miguel Servet
        • Contact:
          • Araceli Rubio
        • Principal Investigator:
          • Araceli Rubio
        • Principal Investigator:
          • Ana Godoy
      • Zaragoza, Spain
        • Recruiting
        • H. Clinico Un. Lozano Blesa
        • Contact:
          • Luis Palomera
        • Principal Investigator:
          • Luis Palomera
      • Zaragoza, Spain
        • Recruiting
        • H. Royo Villanova
        • Contact:
          • Vicente Carrasco
        • Principal Investigator:
          • Vicente Carrasco
      • Ávila, Spain
        • Recruiting
        • H. Ntra. Señora Sonsoles
        • Contact:
          • Abelardo Bárez
        • Principal Investigator:
          • Abelardo Bárez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Every patient receiving 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 will be included in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: Throughout the study period. Approximately 3 years

The percentage of participants with the best overall confirmed response: partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR).

per International Myeloma Working Group (IMWG) uniform response criteria.
Throughout the study period. Approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events (AEs)
Time Frame: Throughout the study period. Approximately 3 years
Number and percentage of treatment-emergent adverse events (AEs)
Throughout the study period. Approximately 3 years
Incidence of ocular events
Time Frame: Throughout the study period. Approximately 3 years
Number and percentage of ocular events
Throughout the study period. Approximately 3 years
Duration of response (DOR)
Time Frame: Throughout the study period. Approximately 3 years
The time from first date of PR or better to date of disease progression or death due to any cause.
Throughout the study period. Approximately 3 years
Time to response (TTR)
Time Frame: Throughout the study period. Approximately 3 years
The time from date of first dose of belantamab mafodotin to date of first occurrence of response.
Throughout the study period. Approximately 3 years
Time to next treatment (TTNT).
Time Frame: Throughout the study period. Approximately 3 years
The time from first dose of belantamab mafodotin to first day when subject receives another myeloma treatment.
Throughout the study period. Approximately 3 years
Progression free survival (PFS)
Time Frame: Throughout the study period. Approximately 3 years
The time from start of treatment until progression or death from any cause
Throughout the study period. Approximately 3 years
Overall survival (OS)
Time Frame: Throughout the study period. Approximately 3 years
The time from start of treatment until death from any cause.
Throughout the study period. Approximately 3 years
Second progression free survival (PFS2)
Time Frame: Throughout the study period. Approximately 3 years
The time from start of belantamab mafodotin to progression on next-line treatment, or death from any cause, whichever is earlier; otherwise censored at the last time known to be alive and without second objective disease progression.
Throughout the study period. Approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Javier de la Rubia, Hospital La Fe Valencia
  • Principal Investigator: Adrián Alegre, Hospital La Princesa (Madrid)
  • Principal Investigator: María Victoria Mateos, Hospital Clínico, Salamanca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEM-RELAMAB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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