Last updated: 03/11/2025 05:01:05
Standard of Care in second and third line of therapy for Multiple Myeloma
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Standards of Care, Treatment Patterns, and Outcomes among Incident 2L and 3L Therapy for Multiple Myeloma
Trial description: The purpose of the study is to describe standard of care (SOC) for second line (2L) and third line (3L) multiple myeloma (MM) treatments in addition to describing Baseline demographic and clinical characteristics, treatment patterns and outcomes for each of regimens in these lines of therapies (LOTs).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with at least 1 non-maintenance non-transplant drug episode date
Timeframe: Up to 3 years
Baseline demographics of participants initiating 2L and 3L therapies
Timeframe: Up to 3 years
Clinical characteristics of participants initiating 2L and 3L therapies
Timeframe: Up to 3 years
Treatment regimens of participants initiating 2L and 3L therapies
Timeframe: Up to 3 years
Duration of treatment (DOT)
Timeframe: Up to 3 years
Time to next treatment or death (TTNTD)
Timeframe: Up to 3 years
Discontinuation of index regimen
Timeframe: Up to 3 years
Overall survival (OS)
Timeframe: Up to 3 years
Progression free survival (PFS)
Timeframe: Up to 3 years
Secondary outcomes:
Baseline characteristics of participants with at least 1 drug episode record for Belantamab Mafodotin (belamaf)
Timeframe: Up to 1 year
Clinical characteristics of participants with at least 1 drug episode record for belamaf
Timeframe: Up to 1 year
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-23-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
NA
Study date(s)
September 2021 to November 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Primary objective 1: From the Flatiron Health Multiple Myeloma Analytic Cohort: 1. Participants with at least 1 non-maintenance non-transplant drug episode date at any time in 2L or 3L during 2018, 2019, 2020.
- Primary objectives 2-4: From the Flatiron Health Multiple Myeloma Analytic Cohort: 1.Participants with 2L or 3L start date between 01-Jan-2018 and the most recent month of available data minus 3 months (start of line = index date).
- Participants with no structured activity within 90 days after their initial MM diagnosis.
- Participants with any oncology-related clinical study drug (as flagged by Flatiron) in any line any time during the study period (primary objective 1: 2018-2020; primary objectives 2-4: 2018 – end of database, 2021; secondary objective: Aug, 2020 – end of database, 2021).
Inclusion and exclusion criteria
Inclusion criteria:
- Primary objective 1: From the Flatiron Health Multiple Myeloma Analytic Cohort: 1. Participants with at least 1 non-maintenance non-transplant drug episode date at any time in 2L or 3L during 2018, 2019, 2020.
- Primary objectives 2-4: From the Flatiron Health Multiple Myeloma Analytic Cohort: 1.Participants with 2L or 3L start date between 01-Jan-2018 and the most recent month of available data minus 3 months (start of line = index date).
- Secondary objective: From the Flatiron Health Multiple Myeloma Analytic Cohort: 1. Participants with at least 1 drug episode date for belamaf between 05-Aug-2020 (the date of the FDA approval) and the end of most recent data.
Exclusion criteria:
- Participants with no structured activity within 90 days after their initial MM diagnosis.
- Participants with any oncology-related clinical study drug (as flagged by Flatiron) in any line any time during the study period (primary objective 1: 2018-2020; primary objectives 2-4: 2018 – end of database, 2021; secondary objective: Aug, 2020 – end of database, 2021).
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
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
2021-23-11
Actual study completion date
2021-23-11
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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Access to clinical trial data by researchers
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