Last updated: 02/01/2022 13:00:08
Comparative analyses of belantamab mafodotin in DREAMM-2 vs. Comparators in relapsed/refractory multiple myeloma (RRMM) participants
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: PAIC Analyses of Belantamab Mafodotin in DREAMM-2 vs. Comparators for Late-line Treatment of Patients with Relapsed/Refractory Multiple Myeloma
Trial description: GlaxoSmithKline (GSK) has been developing a B-cell maturation antigen (BCMA)-targeting therapy, belantamab mafodotin which was evaluated in a Phase 2 trial. GSK seeks to conduct an analysis in order to contextualise the comparative effectiveness of belantamab mafodotin in participants with RRMM after >=3 prior lines of treatment, including proteasome inhibitors (PI), immunomodulatory drugs (IMiDs) and monotherapy or combination therapy of anti-cluster of differentiation 38 (CD38) antibody. In the absence of clinical studies providing a head-to-head comparison of belantamab mafodotin versus comparators, an indirect treatment comparison is needed to evaluate the relative efficacy of these treatments. This study will assess the relative efficacy of belantamab mafodotin versus comparators by conducting unanchored population-adjusted indirect comparison (PAIC) using individual participant-level data from the DREAMM-2 study and aggregated data from the comparator studies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Overall survival (OS)
Timeframe: Up to 2 years
Progression-free survival (PFS)
Timeframe: Up to 2 years
Overall response rate (ORR)
Timeframe: Up to 2 years
Secondary outcomes:
Number of participants with Grade 3 or 4 adverse events (AEs)
Timeframe: Up to 2 years
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-03-08
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Prawitz T, Popat R, Suvannasankha A, Sarri G, Hughes R, Wang F, Hogea C, Ferrante S, Gorsh B, Willson J, Kapetanakis V.DREAMM-2: Indirect Comparisons of Belantamab Mafodotin vs Selinexor + Dexamethasone and Standard of Care in Relapsed/Refractory Multiple Myeloma.Adv Ther.2021;
DOI: https://doi.org/10.1007/s12325-021-01884-7
PMID: 34561812
Medical condition
Neoplasms, Multiple Myeloma
Product
GSK2857916
Collaborators
NA
Study date(s)
November 2019 to August 2020
Type
Observational
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Phase II or above studies that reported efficacy or safety data on populations where at least 80% of participants received three lines or more of prior systemic therapies for multiple myeloma for identification of comparator arm.
- Participants who had at least three prior lines of therapy in DREAMM-2 study and the STORM Part 1 and Part 2 studies.
- NA
Inclusion and exclusion criteria
Inclusion criteria:
- Phase II or above studies that reported efficacy or safety data on populations where at least 80% of participants received three lines or more of prior systemic therapies for multiple myeloma for identification of comparator arm.
- Participants who had at least three prior lines of therapy in DREAMM-2 study and the STORM Part 1 and Part 2 studies.
- STORM Part 1 and 2 studies enrolled participants refractory to lenalidomide, pomalidomide, bortezomib, and carfilzomib.
- Prior exposure and refractory status to daratumumab was similar in the DREAMM-2 study, the STORM Part 2 primary population, and the STORM Part 1 penta-refractory cohort.
Exclusion criteria:
- NA
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
2020-03-08
Actual study completion date
2020-03-08
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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