Last updated: 04/07/2025 09:32:38

A retrospective study of participants treated with belantamab mafodotin (Blenrep) as a part of temporary expanded access (ATU) or Post-ATU period - ALFA STUDY

GSK study ID
214820
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Retrospective analysis of patients treated with belantamab mafodotin (Blenrep) in the ATU and post-ATU periods-ALFA study
Trial description: The goal of this observational study is to provide efficacy and safety data for Blenrep (belantamab mafodotin) in adult participants with relapsed/refractory multiple myeloma (RRMM) treated as part of a cohort expanded access scheme (cATU) or post-expanded access scheme in France.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Overall response rate (ORR)

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Clinical benefit rate (CBR)

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Duration of Response (DoR)

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Progression free-survival (PFS)

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Secondary outcomes:

Median overall survival (mOS)

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Time to next treatment (TTNT)

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Sociodemographic characteristics of participants who initiated belantamab mafodotin

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Clinical characteristics of participants who initiated belantamab mafodotin

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Myeloma characteristics of participants who initiated belantamab mafodotin

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Treatment history from diagnosis to belantamab mafotodin initiation

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Description of methods of use of belantamab mafodotin

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Number of participants with serious adverse events (SAE)

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Number of participants with adverse events (AE) related to treatment

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Number of participants with AE of interest including corneal adverse events and their management

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Number of participants with AE leading to treatment discontinuation

Timeframe: Time period from 27 April 2020 to 30 June 2021 (approximately 14 months)

Interventions:
Not applicable
Enrollment:
180
Primary completion date:
2022-31-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
November 2021 to August 2022
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participants aged 18 years and older
  • Participants who started belantamab mafodotin during the cohort expanded access scheme (ATUc) from 27 April to 10 December 2020 or post-expanded access scheme (post-ATU) from 11 December 2020 to 30 June 2021, regardless of treatment line and treatment status (ongoing or not) at the time of data collection
  • Participants who started belantamab mafodotin as part of a nominative expanded access programme (nATU) or as part of an interventional trial
  • Participants who opposed to their data being collected
Inclusion and exclusion criteria
Inclusion criteria:

    Participants aged 18 years and older

    • Participants who started belantamab mafodotin during the cohort expanded access scheme (ATUc) from 27 April to 10 December 2020 or post-expanded access scheme (post-ATU) from 11 December 2020 to 30 June 2021, regardless of treatment line and treatment status (ongoing or not) at the time of data collection
    • Participants who do not object to their data being collected
Exclusion criteria:

    Participants who started belantamab mafodotin as part of a nominative expanded access programme (nATU) or as part of an interventional trial

    • Participants who opposed to their data being collected

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2022-31-08
Actual study completion date
2022-31-08

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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