Last updated: 04/04/2025 10:10:35
Comparative effectiveness of belamaf (DRiving Excellence in Approaches to Multiple Myeloma [DREAMM-2] Study) to support the United Kingdom National Institute for Health and Care Excellence (NICE) submission
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: MAIC Analyses of Belantamab Mafodotin in DREAMM-2 vs. Pomalidomide with dexamethasone and Panobinostat with Bortezomib and Dexamethasone for Patients with Fifth Line Plus Triple Class Refractory Multiple Myeloma
Trial description: This study aims to assess the feasibility of and where appropriate conduct an indirect treatment comparisons of belantamab mafodotin (belamaf) versus pomalidomide plus dexamethasone (PomDex) and panobinostat, bortezomib plus dexamethasone (PanoBorDex) to support the United Kingdom (UK) Health technology assessment (HTA) appraisals of DREAMM-2.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Overall survival (OS)
Timeframe: Initiation of first eligible line of therapy until failure (all cause death) (Up to 6 months)
Time to next treatment (TTNT)
Timeframe: Time from initiation of index therapy to the earliest of new line of therapy start, or death (censored) (Up to 6 months)
Time to discontinuation (TTD)
Timeframe: Time from initiation of therapy to the discontinuation of therapy or death (censored) (Up to 6 months)
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-28-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
bortezomib
Collaborators
Not applicable
Study date(s)
September 2022 to April 2023
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participants with RRMM after failure of four lines of therapy (5th or higher line of therapy [5L+]), including a proteasome inhibitor, an immunomodulatory agent, and an anti-cluster of differentiation 38 (anti-CD38) antibody will be included.
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Participants with RRMM after failure of four lines of therapy (5th or higher line of therapy [5L+]), including a proteasome inhibitor, an immunomodulatory agent, and an anti-cluster of differentiation 38 (anti-CD38) antibody will be included.
Exclusion criteria:
- Not applicable
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Statistical analysis plan
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
2023-28-04
Actual study completion date
2023-28-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website