Last updated: 12/16/2024 08:00:09
Safety and effectiveness of Belantamab Mafodotin for Multiple Myeloma using the Flatiron Health Database
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2023-18-08
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
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- Confirmed diagnosis of Multiple myeloma (MM)
- Greater than or equal to (>=) 1 record for belantamab mafodotin (first observed record defines the index date)
- Greater than or equal to (>=) 18 years at index date
Exclusion criteria:
- 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
- If a participant participated in an interventional clinical trial after belantamab mafodotin administration, the date of the first record for participation in the interventional clinical trial would represent the end of the participant’s study period
Trial location(s)
No location data available.
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
Finalized
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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