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

Sponsor
PETHEMA Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT05297240
Collaborator
GlaxoSmithKline (Industry)
170
Enrollment
62
Locations
8.3
Anticipated Duration (Months)
2.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Belantamab mafodotin

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 Design

Study Type:
Observational
Anticipated Enrollment :
170 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Retrospective Study of the Use of Belantamab Mafodotin (Blenrep®) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) in Spain.
Actual Study Start Date :
Mar 24, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Overall response rate (ORR) [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.

Secondary Outcome Measures

  1. Incidence of treatment-emergent adverse events (AEs) [Throughout the study period. Approximately 3 years]

    Number and percentage of treatment-emergent adverse events (AEs)

  2. Incidence of ocular events [Throughout the study period. Approximately 3 years]

    Number and percentage of ocular events

  3. Duration of response (DOR) [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.

  4. Time to response (TTR) [Throughout the study period. Approximately 3 years]

    The time from date of first dose of belantamab mafodotin to date of first occurrence of response.

  5. Time to next treatment (TTNT). [Throughout the study period. Approximately 3 years]

    The time from first dose of belantamab mafodotin to first day when subject receives another myeloma treatment.

  6. Progression free survival (PFS) [Throughout the study period. Approximately 3 years]

    The time from start of treatment until progression or death from any cause

  7. Overall survival (OS) [Throughout the study period. Approximately 3 years]

    The time from start of treatment until death from any cause.

  8. Second progression free survival (PFS2) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 H. Universitario de Albacete Albacete Spain
2 H. Doctor José Molina Orosa Arrecife Spain
3 H. San Agustín Avilés Spain
4 H. Clinic de Barcelona Barcelona Spain
5 H. Moises Broggi Barcelona Spain
6 H. Vall d' Hebron Barcelona Spain
7 H. Basurto Bilbao Spain
8 H. Cruces Bilbao Spain
9 H. Calahorra Calahorra Spain
10 H. Reina Sofía Córdoba Spain
11 H. General Elche Elche Spain
12 H. Fuenlabrada Fuenlabrada Spain
13 H. Galdakao Galdakao Spain
14 H. Francisco de Borja Gandia Spain
15 ICO Girona Girona Spain
16 H. Un. Virgen de las Nieves Granada Spain
17 H. Un. Guadalajara Guadalajara Spain
18 H. Juan Ramón Jiménez Huelva Spain
19 H. Universitario de Jaén Jaén Spain
20 H. Un. Doctor Negrín Las Palmas De Gran Canaria Spain
21 H. Severo Ochoa Leganés Spain
22 H. León León Spain
23 H. San Pedro Logroño Spain
24 H. Un. Lucus Augusti Lugo Spain
25 Fundación Jiménez Díaz Madrid Spain
26 H. Gregorio Marañón Madrid Spain
27 H. Moncloa Madrid Spain
28 H. Ruber Juan Bravo Madrid Spain
29 H. Un. Doce de Octubre Madrid Spain
30 H. Un. Infanta Sofía Madrid Spain
31 H. Un. La Paz Madrid Spain
32 H. Un. La Princesa Madrid Spain
33 H. Un. Puerta del Hierro Madrid Spain
34 H. Un. Quirón Salud Madrid Spain
35 H.M. Sanchinarro Madrid Spain
36 Hospital Clínico San Carlos Madrid Spain
37 Hospital Universitario Henares Madrid Spain
38 Hospital Universitario Ramón y Cajal Madrid Spain
39 H. Morales Meseguer Murcia Spain
40 H. Un. Virgen de la Arrixaca Murcia Spain
41 H. Virgen de la Victoria Málaga Spain
42 H. Rey Juan Carlos Móstoles Spain
43 H. Universitario Central Asturias Oviedo Spain
44 H. Son Llatzer Palma De Mallorca Spain
45 H. Un. Son Espases Palma De Mallorca Spain
46 H. Montecelo Pontevedra Spain
47 H. Un. Salamanca Salamanca Spain
48 H. Un. Canarias Santa Cruz De Tenerife Spain
49 H. Un. Marqués de Valdecilla Santander Spain
50 H. General Segovia Segovia Spain
51 H. Un. Virgen de Valme Sevilla Spain
52 H. Virgen del Rocío Sevilla Spain
53 H. Mutua Terrasa Terrassa Spain
54 H. Ntra. Señora del Prado Toledo Spain
55 H. Un. Torrejón Torrejón De Ardoz Spain
56 H. Un. Dr. Peset Valencia Spain
57 H. Universitario de la Fe Valencia Spain
58 H. Universitario de Valladolid Valladolid Spain
59 H. Clinico Un. Lozano Blesa Zaragoza Spain
60 H. Miguel Servet Zaragoza Spain
61 H. Royo Villanova Zaragoza Spain
62 H. Ntra. Señora Sonsoles Ávila Spain

Sponsors and Collaborators

  • PETHEMA Foundation
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT05297240
Other Study ID Numbers:
  • GEM-RELAMAB
First Posted:
Mar 28, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of Aug 5, 2022