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

RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05297240
• Other study ID #: GEM-RELAMAB
• Status: Recruiting
• Start date: March 24, 2022
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: PETHEMA Foundation
• Contact: Carmen López-Carrero
• Phone: 0034 699 835 437
• Email: carmen[@]fundacionpethema.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Spain	H. Universitario de Albacete	Albacete
Spain	H. Doctor José Molina Orosa	Arrecife
Spain	H. Ntra. Señora Sonsoles	Ávila
Spain	H. San Agustín	Avilés
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	Sevilla
Spain	H. Virgen del Rocío	Sevilla
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

Sponsors (2)

Lead Sponsor	Collaborator
PETHEMA Foundation	GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

References & Publications (24)

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Kumar SK, Dispenzieri A, Lacy MQ, Gertz MA, Buadi FK, Pandey S, Kapoor P, Dingli D, Hayman SR, Leung N, Lust J, McCurdy A, Russell SJ, Zeldenrust SR, Kyle RA, Rajkumar SV. Continued improvement in survival in multiple myeloma: changes in early mortality and outcomes in older patients. Leukemia. 2014 May;28(5):1122-8. doi: 10.1038/leu.2013.313. Epub 2013 Oct 25. — View Citation

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Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Lendvai N, Sborov D, Suvannasankha A, Weisel K, Karlin L, Libby E, Arnulf B, Facon T, Hulin C, Kortüm KM, Rodríguez-Otero P, Usmani SZ, Hari P, Baz R, Quach H, Moreau P, Voorhees PM, Gupta I, Hoos A, Zhi E, Baron J, Piontek T, Lewis E, Jewell RC, Dettman EJ, Popat R, Esposti SD, Opalinska J, Richardson P, Cohen AD. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020 Feb;21(2):207-221. doi: 10.1016/S1470-2045(19)30788-0. Epub 2019 Dec 16. — View Citation

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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, Lüoend 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, Umaña 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. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	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	Incidence of treatment-emergent adverse events (AEs)	Number and percentage of treatment-emergent adverse events (AEs)	Throughout the study period. Approximately 3 years
Secondary	Incidence of ocular events	Number and percentage of ocular events	Throughout the study period. Approximately 3 years
Secondary	Duration of response (DOR)	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
Secondary	Time to response (TTR)	The time from date of first dose of belantamab mafodotin to date of first occurrence of response.	Throughout the study period. Approximately 3 years
Secondary	Time to next treatment (TTNT).	The time from first dose of belantamab mafodotin to first day when subject receives another myeloma treatment.	Throughout the study period. Approximately 3 years
Secondary	Progression free survival (PFS)	The time from start of treatment until progression or death from any cause	Throughout the study period. Approximately 3 years
Secondary	Overall survival (OS)	The time from start of treatment until death from any cause.	Throughout the study period. Approximately 3 years
Secondary	Second progression free survival (PFS2)	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