Last updated: 01/06/2025 07:40:09
Historical control for DREAMM 2 study
GSK study ID
212481
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Contemporaneous Historical Control Arm in Tri-Exposed, PI/IMiD-refractory Multiple Myeloma
Trial description: The primary objective of this study is to compare effectiveness outcomes between real world participants and the DREAMM 2 clinical study of belantamab mafodotin. The participations included were tri-exposed, and also refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD). Tri-exposure is any exposure to at least one immunomodulatory agent, at least one PI and the anti-cluster of differentiation (CD)38 monoclonal antibody (mAB) daratumumab at any time during a participant’s treatment course. This is an observational, retrospective study with secondary use of data derived from the two United States (US) based real-world cohorts (Flatiron Health Analytic Database and Vector Oncology electronic medical record [EMR]); and European Union (EU) chart review obtained from participants medical records and clinical chart review. The pooled real world cohort will be matched to the DREAMM 2 study (NCT03525678) population using inverse probability weighting or a similar method, for the purposes of comparing effectiveness outcomes in these population. Real-world clinical data using the Flatiron’s electronic health records (EHRs) will be collected from 01 January 2011 to 31 May 2019 (data cut-off date). Vector oncology data will be collected from participants with histologically or cytologically confirmed multiple myeloma (MM) diagnosis on or after 01 January 2010. EU chart review study will be conducted across multiple centers in EU region and data will be collected from index date to date of data collection (latest 06 September 2019), death or loss of follow-up, whichever occurs first.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Derived progression free survival
Timeframe: Up to 8.5 years
Derived time to progression
Timeframe: Up to 8.5 years
Overall survival
Timeframe: Up to 8.5 years
Derived overall response rate
Timeframe: Up to 8.5 years
Derived duration of response
Timeframe: Up to 8.5 years
Secondary outcomes:
Derived progression free survival in US real-world cohorts
Timeframe: Up to 8.5 years
Derived time to progression in US real-world cohorts
Timeframe: Up to 8.5 years
Overall survival in US real-world cohorts
Timeframe: Up to 8.5 years
Derived overall response rate in US real-world cohorts
Timeframe: Up to 8.5 years
Derived duration of response in US real-world cohorts
Timeframe: Up to 8.5 years
Derived time to response in US real-world cohorts
Timeframe: Up to 8.5 years
Minimal residual disease negativity in Vector Oncology cohort
Timeframe: Up to 8.5 years
Interventions:
Not applicable
Enrollment:
250
Primary completion date:
2023-31-03
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
Flatiron Health, Concerto (Vector Oncology), IQVIA
Study date(s)
November 2019 to March 2023
Type
Observational
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Flatiron EMR:
- Diagnosis of MM (International Classification of Diseases [ICD]-9 203.0x or ICD-10 C90.0x, C90), as identified in structured data.
Inclusion and exclusion criteria
Inclusion criteria:
- Flatiron EMR:
- Diagnosis of MM (International Classification of Diseases [ICD]-9 203.0x or ICD-10 C90.0x, C90), as identified in structured data.
- Pathology consistent with MM, as confirmed in unstructured data.
- Has evidence of MM with a diagnosis date on or after 01 January 2011 and at least two visits in the Flatiron Health database on different days on or after 01 January 2011.
- Has a fourth line (4L)+ line of therapy identifiable in the database which is subsequent to the line of therapy that made the participant eligible for inclusion. Vector Oncology EMR:
- Histologically or cytologically confirmed MM diagnosis through clinical research nurse review of the medical record.
- Diagnosis of MM on or after 01 January 2010.
- Has a 4L+ line of therapy identifiable in the database which is subsequent to the line of therapy that made the participant eligible for inclusion EU Chart review cohort:
- MM diagnosis confirmed via physician review of medical record.
- Has a date of initiation for a 4th or later therapy line in their chart, which is subsequent to the line of therapy that made the participant eligible for inclusion.
- Participants identified in a backward consecutive way from 30 June 2018 to 30 June 2016.
- Participants who are alive and are still in the study (no loss of follow-up) at date of data collection will have a minimum follow-up period of 14 months.
- Availability of full MM clinical chart at the participant site. Exclusion Criteria: Flatiron EMR:
- Participants lacking relevant documents in the Flatiron database.
- Participants for whom therapy data may be missing.
- Participants whose start date of MM treatment (as captured through unstructured data) is >30 days before the start of structured activity (“Line 0” participants). Vector Oncology EMR:
- Participants lacking relevant documents in the Vector Oncology database.
- Participants who have missing therapy data for index. EU Chart review cohort:
- Participants lacking relevant documents; only those participants with full charts are included in the EU Chart review cohort.
- Participants who have missing therapy data for index.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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