Clinical trial NCT05297240: Retrospective Study of the Use of Belantamab Mafodotin (Blenrep®) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) in Spain.
Official title: Retrospective Study of the Use of Belantamab Mafodotin (Blenrep®) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) in Spain.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2022-03-28
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

Brief 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).

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.

Eligibility 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

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: Throughout the study period. Approximately 3 years
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events (AEs)
timeFrame: Throughout the study period. Approximately 3 years
measure: Incidence of ocular events
timeFrame: Throughout the study period. Approximately 3 years
measure: Duration of response (DOR)
timeFrame: Throughout the study period. Approximately 3 years
measure: Time to response (TTR)
timeFrame: Throughout the study period. Approximately 3 years
measure: Time to next treatment (TTNT).
timeFrame: Throughout the study period. Approximately 3 years
measure: Progression free survival (PFS)
timeFrame: Throughout the study period. Approximately 3 years
measure: Overall survival (OS)
timeFrame: Throughout the study period. Approximately 3 years
measure: Second progression free survival (PFS2)
timeFrame: Throughout the study period. Approximately 3 years
Other outcomes:
Locations:
city: Albacete
country: Spain
facility: H. Universitario de Albacete
city: Arrecife
country: Spain
facility: H. Doctor José Molina Orosa
city: Avilés
country: Spain
facility: H. San Agustín
city: Barcelona
country: Spain
facility: H. Clinic de Barcelona
city: Barcelona
country: Spain
facility: H. Moises Broggi
city: Barcelona
country: Spain
facility: H. Vall d' Hebron
city: Bilbao
country: Spain
facility: H. Basurto
city: Bilbao
country: Spain
facility: H. Cruces
city: Calahorra
country: Spain
facility: H. Calahorra
city: Córdoba
country: Spain
facility: H. Reina Sofía
city: Elche
country: Spain
facility: H. General Elche
city: Fuenlabrada
country: Spain
facility: H. Fuenlabrada
city: Galdakao
country: Spain
facility: H. Galdakao
city: Gandia
country: Spain
facility: H. Francisco de Borja
city: Girona
country: Spain
facility: ICO Girona
city: Granada
country: Spain
facility: H. Un. Virgen de las Nieves
city: Guadalajara
country: Spain
facility: H. Un. Guadalajara
city: Huelva
country: Spain
facility: H. Juan Ramón Jiménez
city: Jaén
country: Spain
facility: H. Universitario de Jaén
city: Las Palmas De Gran Canaria
country: Spain
facility: H. Un. Doctor Negrín
city: Leganés
country: Spain
facility: H. Severo Ochoa
city: León
country: Spain
facility: H. León
city: Logroño
country: Spain
facility: H. San Pedro
city: Lugo
country: Spain
facility: H. Un. Lucus Augusti
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: H. Gregorio Marañón
city: Madrid
country: Spain
facility: H. Moncloa
city: Madrid
country: Spain
facility: H. Ruber Juan Bravo
city: Madrid
country: Spain
facility: H. Un. Doce de Octubre
city: Madrid
country: Spain
facility: H. Un. Infanta Sofía
city: Madrid
country: Spain
facility: H. Un. La Paz
city: Madrid
country: Spain
facility: H. Un. La Princesa
city: Madrid
country: Spain
facility: H. Un. Puerta del Hierro
city: Madrid
country: Spain
facility: H. Un. Quirón Salud
city: Madrid
country: Spain
facility: H.M. Sanchinarro
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Henares
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Murcia
country: Spain
facility: H. Morales Meseguer
city: Murcia
country: Spain
facility: H. Un. Virgen de la Arrixaca
city: Málaga
country: Spain
facility: H. Virgen de la Victoria
city: Móstoles
country: Spain
facility: H. Rey Juan Carlos
city: Oviedo
country: Spain
facility: H. Universitario Central Asturias
city: Palma De Mallorca
country: Spain
facility: H. Son Llatzer
city: Palma De Mallorca
country: Spain
facility: H. Un. Son Espases
city: Pontevedra
country: Spain
facility: H. Montecelo
city: Salamanca
country: Spain
facility: H. Un. Salamanca
city: Santa Cruz De Tenerife
country: Spain
facility: H. Un. Canarias
city: Santander
country: Spain
facility: H. Un. Marqués de Valdecilla
city: Segovia
country: Spain
facility: H. General Segovia
city: Sevilla
country: Spain
facility: H. Un. Virgen de Valme
city: Sevilla
country: Spain
facility: H. Virgen del Rocío
city: Terrassa
country: Spain
facility: H. Mutua Terrasa
city: Toledo
country: Spain
facility: H. Ntra. Señora del Prado
city: Torrejón De Ardoz
country: Spain
facility: H. Un. Torrejón
city: Valencia
country: Spain
facility: H. Un. Dr. Peset
city: Valencia
country: Spain
facility: H. Universitario de la Fe
city: Valladolid
country: Spain
facility: H. Universitario de Valladolid
city: Zaragoza
country: Spain
facility: H. Clinico Un. Lozano Blesa
city: Zaragoza
country: Spain
facility: H. Miguel Servet
city: Zaragoza
country: Spain
facility: H. Royo Villanova
city: Ávila
country: Spain
facility: H. Ntra. Señora Sonsoles
Study officials:
affiliation: HOSPITAL LA FE VALENCIA
name: Javier de la Rubia
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital La Princesa (Madrid)
name: Adrián Alegre
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico, Salamanca
name: María Victoria Mateos
role: PRINCIPAL_INVESTIGATOR
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