Last updated: 07/27/2020 19:50:04

B cell maturation antigen (BCMA) historical control for phase I in multiple myeloma (MM)

GSK study ID
212129
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: BCMA historical control for phase I in Multiple Myeloma patients
Trial description: Despite recent improvements in clinical outcomes for patients with multiple myeloma (MM), subjects who have already received three lines of therapy continue to have a poor prognosis and a high burden of disease. A real world cohort of patients who have been pre-treated with proteasome inhibitors (PI), immunomodulatory drug (IMiD) and an anti-CD38 antibody will be identified as the main study population for this current study. The primary objective of the study is to compare outcomes of a subset of the main study population who had also have prior exposure to an alkylating agent, with the clinical study outcomes of the daratumumab exposed subgroup in the GSK2857916 DREAMM 1 [NCT03525678] study. The secondary objective is to describe subject’s demographic and clinical characteristics and to examine effectiveness outcomes in the main study population, as well as in a subgroup of the main study population who resemble the DREAMM 2 [NCT03525678] study population (double-refractory to PI and IMiD, and failing CD38 treatment). This is an observational retrospective study with secondary use of data derived from the Flatiron Health Analytic Database and will include all relevant retrospective subject-level data available for all MM subjects from 01-Jan-2011 to 30-Nov-2018. Flatiron is the registered trademark of Flatiron Health.
This study was withdrawn, therefore no analysis was done and no results are available.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects with derived progression free survival (dPFS) in Real-world cohort plus Trial population cohort

Timeframe: Up to 95 months

Number of subjects with derived time to progression (dTTP) in Real-world cohort plus Trial population cohort

Timeframe: Up to 95 months

Number of subjects with overall Survival (OS) rate in Real-world cohort plus Trial population cohort

Timeframe: Up to 95 months

Secondary outcomes:

Number of subjects with dPFS in Real-world cohort

Timeframe: Up to 95 months

Number of subjects with dTTP in Real-world cohort

Timeframe: Up to 95 months

Number of subjects with OS rate in Real-world cohort

Timeframe: Up to 95 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-30-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
GSK2857916
Collaborators
Flatiron
Study date(s)
March 2019 to April 2020
Type
Observational
Phase
2

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Diagnosis of MM (International Classification of Diseases [ICD]-9 203.0x or ICD-10 C90.0x, C90), as identified in structured data.
  • At least two visits in the Flatiron Health database on or after 01-Jan-2011, as identified in structured data.
  • Subjects lacking relevant unstructured documents in the Flatiron database.
  • Subjects who start date of MM treatment (as captured through unstructured data) is >30 days before the start of structured activity (“Line 0” subjects).
Inclusion and exclusion criteria
Inclusion criteria:
  • Diagnosis of MM (International Classification of Diseases [ICD]-9 203.0x or ICD-10 C90.0x, C90), as identified in structured data.
  • At least two visits in the Flatiron Health database on or after 01-Jan-2011, 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-Jan-2011, as confirmed in unstructured data.
  • Confirmed exposure to at least one IMiD agent (i.e., lenalidomide, pomalidomide, thalidomide), at least one PI (i.e., bortezomib, carfilzomib, ixazomib), and the anti-CD38 mAB daratumumab.
Exclusion criteria:
  • Subjects lacking relevant unstructured documents in the Flatiron database.
  • Subjects who start date of MM treatment (as captured through unstructured data) is >30 days before the start of structured activity (“Line 0” subjects).
  • Subjects treated outside of community oncology practices in the Flatiron network. This cohort will exclude subjects treated in the Academic setting, given the limited availability of M spike data from Academic sites in the Flatiron network.

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
2020-30-04
Actual study completion date
2020-30-04

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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