Retrospective Study of the Use of Belantamab Mafodotin (Blenrep®) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) in Spain.
NCT ID: NCT05297240
Last Updated: 2022-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
170 participants
OBSERVATIONAL
2022-03-24
2022-12-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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Belantamab mafodotin
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.
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
PETHEMA Foundation
OTHER
Responsible Party
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Principal Investigators
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Javier de la Rubia
Role: PRINCIPAL_INVESTIGATOR
Hospital La Fe de Valencia
Adrián Alegre
Role: PRINCIPAL_INVESTIGATOR
Hospital La Princesa (Madrid)
María Victoria Mateos
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico, Salamanca
Locations
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H. Universitario de Albacete
Albacete, , Spain
H. Doctor José Molina Orosa
Arrecife, , Spain
H. San Agustín
Avilés, , Spain
H. Ntra. Señora Sonsoles
Ávila, , Spain
H. Clinic de Barcelona
Barcelona, , Spain
H. Moises Broggi
Barcelona, , Spain
H. Vall d' Hebron
Barcelona, , Spain
H. Basurto
Bilbao, , Spain
H. Cruces
Bilbao, , Spain
H. Calahorra
Calahorra, , Spain
H. Reina Sofía
Córdoba, , Spain
H. General Elche
Elche, , Spain
H. Fuenlabrada
Fuenlabrada, , Spain
H. Galdakao
Galdakao, , Spain
H. Francisco de Borja
Gandia, , Spain
ICO Girona
Girona, , Spain
H. Un. Virgen de las Nieves
Granada, , Spain
H. Un. Guadalajara
Guadalajara, , Spain
H. Juan Ramón Jiménez
Huelva, , Spain
H. Universitario de Jaén
Jaén, , Spain
H. Un. Doctor Negrín
Las Palmas de Gran Canaria, , Spain
H. Severo Ochoa
Leganés, , Spain
H. León
León, , Spain
H. San Pedro
Logroño, , Spain
H. Un. Lucus Augusti
Lugo, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
H. Gregorio Marañón
Madrid, , Spain
H. Moncloa
Madrid, , Spain
H. Ruber Juan Bravo
Madrid, , Spain
H. Un. Doce de Octubre
Madrid, , Spain
H. Un. Infanta Sofía
Madrid, , Spain
H. Un. La Paz
Madrid, , Spain
H. Un. La Princesa
Madrid, , Spain
H. Un. Puerta del Hierro
Madrid, , Spain
H. Un. Quirón Salud
Madrid, , Spain
H.M. Sanchinarro
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario Henares
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
H. Virgen de la Victoria
Málaga, , Spain
H. Rey Juan Carlos
Móstoles, , Spain
H. Morales Meseguer
Murcia, , Spain
H. Un. Virgen de la Arrixaca
Murcia, , Spain
H. Universitario Central Asturias
Oviedo, , Spain
H. Son Llatzer
Palma de Mallorca, , Spain
H. Un. Son Espases
Palma de Mallorca, , Spain
H. Montecelo
Pontevedra, , Spain
H. Un. Salamanca
Salamanca, , Spain
H. Un. Canarias
Santa Cruz de Tenerife, , Spain
H. Un. Marqués de Valdecilla
Santander, , Spain
H. General Segovia
Segovia, , Spain
H. Un. Virgen de Valme
Seville, , Spain
H. Virgen del Rocío
Seville, , Spain
H. Mutua Terrasa
Terrassa, , Spain
H. Ntra. Señora del Prado
Toledo, , Spain
H. Un. Torrejón
Torrejón de Ardoz, , Spain
H. Un. Dr. Peset
Valencia, , Spain
H. Universitario de la Fe
Valencia, , Spain
H. Universitario de Valladolid
Valladolid, , Spain
H. Clinico Un. Lozano Blesa
Zaragoza, , Spain
H. Miguel Servet
Zaragoza, , Spain
H. Royo Villanova
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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Juan Ramón Romero Macías
Role: primary
Víctor Alfonso Ferrandez
Role: primary
Walter Javier Zambrano
Role: primary
Abelardo Bárez
Role: primary
Ana Triguero
Role: primary
María Elena María Elena Cabezudo/Gabriela Bustamante
Role: primary
Mercedes Gironella
Role: primary
José Antonio Márquez
Role: primary
Xavier Martín
Role: primary
Estefanía Ruiz
Role: primary
Margarita Fernández de la Mata
Role: primary
Venancio Conesa
Role: primary
Amaia López
Role: primary
Eukene Gainza
Role: primary
María Ángeles Ruiz
Role: primary
Yolanda González
Role: primary
Esther Clavero
Role: primary
Alejandro Vázquez Ramo
Role: primary
Juan Francisco Domínguez
Role: primary
Magdalena Anguita
Role: primary
Alexia Alexia Suarez Cabrera
Role: primary
Rosalía Riaza
Role: primary
Fernando Escalante
Role: primary
Montserrat Hernández
Role: primary
Esperanza Lavilla
Role: primary
Elena Prieto
Role: primary
Cristina Encinas
Role: primary
Concha Alaez Usón
Role: primary
Aranzazu Alonso Alonso
Role: primary
Joaquin Martínez
Role: primary
Eugenio Giménez
Role: primary
Ana López de la Guía
Role: primary
Gonzalo Benzo
Role: primary
Rafael Ríos Tamayo
Role: primary
Carmen Martínez Chamorro
Role: primary
Laura Llorente
Role: primary
Cristina Pérez
Role: primary
Cristina Muñoz
Role: primary
Maria Jesús Blanchard
Role: primary
Ricarda García
Role: primary
Alberto Eterio Velasco
Role: primary
Felipe de Arriba
Role: primary
Valentín Cabañas
Role: primary
Ángel Ramirez Payer
Role: primary
Raquel del Campo García
Role: primary
José María Sánchez Raga
Role: primary
Ana Maria Dios Loureiro
Role: primary
Ramón García Sanz
Role: primary
Álvaro Bienert García
Role: primary
Maria Aranzazu Bermúdez
Role: primary
Aranzazu García
Role: primary
Eduardo Ríos
Role: primary
Estrella Carrillo
Role: primary
Josep Maria Martí
Role: primary
María Dolores Martínez Moya
Role: primary
Ana Morales
Role: primary
Ana García Feria
Role: primary
Rafael Andreu La Piedra
Role: primary
Alfonso García de Coca
Role: primary
Luis Palomera
Role: primary
Araceli Rubio
Role: primary
Vicente Carrasco
Role: primary
References
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Tai YT, Mayes PA, Acharya C, Zhong MY, Cea M, Cagnetta A, Craigen J, Yates J, Gliddon L, Fieles W, Hoang B, Tunstead J, Christie AL, Kung AL, Richardson P, Munshi NC, Anderson KC. Novel anti-B-cell maturation antigen antibody-drug conjugate (GSK2857916) selectively induces killing of multiple myeloma. Blood. 2014 May 15;123(20):3128-38. doi: 10.1182/blood-2013-10-535088. Epub 2014 Feb 25.
Seckinger A, Delgado JA, Moser S, Moreno L, Neuber B, Grab A, Lipp S, Merino J, Prosper F, Emde M, Delon C, Latzko M, Gianotti R, Luoend R, Murr R, Hosse RJ, Harnisch LJ, Bacac M, Fauti T, Klein C, Zabaleta A, Hillengass J, Cavalcanti-Adam EA, Ho AD, Hundemer M, San Miguel JF, Strein K, Umana P, Hose D, Paiva B, Vu MD. Target Expression, Generation, Preclinical Activity, and Pharmacokinetics of the BCMA-T Cell Bispecific Antibody EM801 for Multiple Myeloma Treatment. Cancer Cell. 2017 Mar 13;31(3):396-410. doi: 10.1016/j.ccell.2017.02.002. Epub 2017 Mar 2.
Moreaux J, Legouffe E, Jourdan E, Quittet P, Reme T, Lugagne C, Moine P, Rossi JF, Klein B, Tarte K. BAFF and APRIL protect myeloma cells from apoptosis induced by interleukin 6 deprivation and dexamethasone. Blood. 2004 Apr 15;103(8):3148-57. doi: 10.1182/blood-2003-06-1984. Epub 2003 Dec 4.
Tai YT, Acharya C, An G, Moschetta M, Zhong MY, Feng X, Cea M, Cagnetta A, Wen K, van Eenennaam H, van Elsas A, Qiu L, Richardson P, Munshi N, Anderson KC. APRIL and BCMA promote human multiple myeloma growth and immunosuppression in the bone marrow microenvironment. Blood. 2016 Jun 23;127(25):3225-36. doi: 10.1182/blood-2016-01-691162. Epub 2016 Apr 28.
Sanchez E, Li M, Kitto A, Li J, Wang CS, Kirk DT, Yellin O, Nichols CM, Dreyer MP, Ahles CP, Robinson A, Madden E, Waterman GN, Swift RA, Bonavida B, Boccia R, Vescio RA, Crowley J, Chen H, Berenson JR. Serum B-cell maturation antigen is elevated in multiple myeloma and correlates with disease status and survival. Br J Haematol. 2012 Sep;158(6):727-38. doi: 10.1111/j.1365-2141.2012.09241.x. Epub 2012 Jul 18.
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Trudel S, Lendvai N, Popat R, Voorhees PM, Reeves B, Libby EN, Richardson PG, Anderson LD Jr, Sutherland HJ, Yong K, Hoos A, Gorczyca MM, Lahiri S, He Z, Austin DJ, Opalinska JB, Cohen AD. Targeting B-cell maturation antigen with GSK2857916 antibody-drug conjugate in relapsed or refractory multiple myeloma (BMA117159): a dose escalation and expansion phase 1 trial. Lancet Oncol. 2018 Dec;19(12):1641-1653. doi: 10.1016/S1470-2045(18)30576-X. Epub 2018 Nov 12.
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Hungria VTM, et al. Real-world (RW) multiple myeloma (MM) patients (Pts) remain under-represented in clinical trials based on standard laboratory parameters and baseline characteristics: analysis of over 3,000 Pts from the Insight MM Global, Prospective, Observational Study. Blood. 2019;134:1887a
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Other Identifiers
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GEM-RELAMAB
Identifier Type: -
Identifier Source: org_study_id
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