Last updated: 12/16/2024 08:00:09

Safety and effectiveness of Belantamab Mafodotin for Multiple Myeloma using the Flatiron Health Database

GSK study ID
218905
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: A Retrospective Assessment of Safety and Effectiveness using the Flatiron Health Database
Trial description: This study evaluates the real-world use, safety and effectiveness of belantamab mafodotin.The index date is defined as the date of the first observed administration of belantamab mafodotin.The post-index period spans from the index date until the end of follow-up (defined as the start of participation in an interventional clinical trial, end of clinical activity, end of data availability, or death; whichever comes first).The post-index treatment period is defined as the duration of the belantamab mafodotin line of treatment. This spans from the index date until the permanent discontinuation of belantamab mafodotin treatment,the confirmed date of a new line of treatment, or the end of follow-up; whichever comes first.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with clinical care, demographics characteristics, disease and treatment history

Timeframe: At index date

Secondary outcomes:

Number of participants with ocular adverse event of special interests (AESIs) related to belantamab mafodotin Treatment (overall and subgroup)

Timeframe: At post-index treatment period

Number of ophthalmic monitoring visits relative to belantamab mafodotin administration

Timeframe: At index date and post-index treatment period

Time of ophthalmic monitoring visits relative to belantamab mafodotin administration

Timeframe: At index date and post-index treatment period

Number of participants with ocular AESIs (overall and subgroup)

Timeframe: At post-index period

Number of participants with impact on treatment discontinuation, delay, and dose modification due to ocular AESIs (overall and subgroup)

Timeframe: At post-index period

Number of participants persistent and adherent to belantamab mafodotin

Timeframe: At post-index period

Number of participants with reasons for treatment discontinuation

Timeframe: At post-index period

Number of participants with reasons for treatment delays, or dose modifications

Timeframe: At post-index period

Overall response rate (ORR)

Timeframe: At post-index period

Duration of response (DoR)

Timeframe: At post-index period

Duration of treatment (DoT)

Timeframe: At post-index period

Time to next treatment (TTNT)

Timeframe: At post-index period

Real-world progression free survival (rwPFS)

Timeframe: At post-index period

Overall survival (OS)

Timeframe: At post-index period

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-18-08
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Malin Hultcrantz, David Kleinman, Ravi Vij, Fernando Escalante, Michel Delforge, Nirali Kotowsky, Jacopo Bitetti, Natalie Boytsov, Leena Camadoo-O'Byrne, Lindsey Powers Happ, Guillaume Germain, Ana Urosevic, Malena Mahendran, Mei Sheng Duh, Francois Laliberte, Michele Cavo, Hans C Lee. Belantamab mafodotin monotherapy for relapsed or refractory multiple myeloma: a real-world observational study in the United States. Haematologica. 2024-Oct-17;  PMID: 39415693 DOI: 10.3324/haematol.2024.285893
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2022 to August 2023
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Confirmed diagnosis of Multiple myeloma (MM)
  • Greater than or equal to (>=) 1 record for belantamab mafodotin (first observed record defines the index date)
  • Participation in an interventional clinical trial during the Baseline period or on the index date ( that is [i.e.,] time of the first belantamab mafodotin administration)
  • Identification of participation in an interventional clinical trial will be based on records for administration of clinical study drugs, contingent on data availability

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English

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
2023-18-08
Actual study completion date
2023-18-08

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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