Last updated: 08/01/2025 08:40:18

RWE generation on the use of belantamab mafodotin in Belgium

GSK study ID
219609
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: Real-world use of belantamab mafodotin for multiple myeloma in Belgium: A retrospective assessment of safety and effectiveness
Trial description: This is an observational retrospective study that aims to describe the real-world use of belantamab mafodotin in Belgium and its outcome in participants with relapsed or refractory multiple myeloma (RRMM).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants achieving a best response - stable disease (SD), complete response (CR), stringent complete response (sCR), very good partial response (VGPR), partial response (PR), minimal response (MR) progressive disease (PD), overall response rate (ORR), Duration of response (DoR), Duration of Treatment (DoT), Time to next treatment (TTNT), Progression-free survival (PFS) or Overall survival (OS)

Timeframe: Up to 35 months

Secondary outcomes:

Number of participants with 1, 2, 3 or more than (≥)4 treatment cycles (3 week cycle) of belantamab mafodotin

Timeframe: Up to 35 months

Average and median number of belantamab mafodotin cycles among all participants

Timeframe: Up to 35 months

Average and median number of belantamab mafodotin cycles among participants receiving greater than 4 cycles

Timeframe: Up to 35 months

Number of participants stopping belantamab mafodotin after a first, a second and a third cycle

Timeframe: Up to 35 months

Number of previous lines of therapy (LOT)

Timeframe: At Index date (Between at or later than 1 Oct 2019 to prior than or on 2 June 2022)

Number of participants with belantamab mafodotin treatment interruptions, delays, discontinuations, and dose modifications

Timeframe: Up to 35 months

Number of participants treated with belantamab mafodotin with and without ocular. Adverse Events of special interest (AESI)

Timeframe: Up to 35 months

Number of participants with ocular AESI with belantamab mafodotin discontinuation, interruption, delay or dose modifications

Timeframe: Up to 35 months

Number of ophthalmic monitoring visits relative to belantamab mafodotin administration

Timeframe: Up to 35 months

Assessment of participant demographic and clinical characteristics at the time of first belantamab infusion

Timeframe: At Index date (Between at or later than 1 Oct 2019 to prior than or on 2 June 2022)

Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2023-20-02
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 2022 to February 2023
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participants with a confirmed International Classification of Diseases, Tenth Revision, Clinical Modification ICD-10-CM diagnosis of MM (C90.00 “Multiple myeloma not having achieved remission” or C90.02 “Multiple myeloma in relapse”).
  • Participants who have received at least one administration of belantamab mafodotin on or after October 1st, 2019, and before or on June 2nd, 2022 (first observed record defines the index date).
  • Concurrent enrolment in any interventional clinical trial at the index date.
  • Use outside the clinical indication per European Union Summary of Product Characteristics (EU SmPC).
Inclusion and exclusion criteria
Inclusion criteria:

    •Participants with a confirmed International Classification of Diseases, Tenth Revision, Clinical Modification ICD-10-CM diagnosis of MM (C90.00 “Multiple myeloma not having achieved remission” or C90.02 “Multiple myeloma in relapse”). •Participants who have received at least one administration of belantamab mafodotin on or after October 1st, 2019, and before or on June 2nd, 2022 (first observed record defines the index date). •Participants ≥18 years at index date.

Exclusion criteria:

    •Concurrent enrolment in any interventional clinical trial at the index date. •Use outside the clinical indication per European Union Summary of Product Characteristics (EU SmPC).

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
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
2023-20-02
Actual study completion date
2023-20-02

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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