Last updated: 08/06/2025 10:00:40

A study evaluating effectiveness of B-Pd versus comparative treatments for participants with 2L+ relapsed/refractory multiple myeloma (RRMM)

GSK study ID
221845
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Matching-adjusted indirect comparison (MAIC) of B-Pd versus comparative treatments for patients with measurable relapsed/refractory multiple myeloma (RRMM) who have previously treated with at least one prior therapy including a lenalidomide-containing regimen
Trial description: This is a non-interventional study with a goal to assess the comparative effectiveness of Belantamab mafodotin plus bortezomib plus dexamethasone (B-Pd) in DREAMM 8 study relative to daratumumab plus pomalidomide plus dexamethasone (DPd) in participants with RRMM.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Progression-free survival (PFS)

Timeframe: Up to approximately 16 years

Secondary outcomes:

Overall survival (OS)

Timeframe: Up to approximately 16 years

Overall response rate (ORR)

Timeframe: Up to approximately 16 years

Very good partial response or better (VGPR+)

Timeframe: Up to approximately 16 years

Complete response or better (CR+)

Timeframe: Up to approximately 16 years

Minimal residual disease (MRD) negativity rate

Timeframe: Up to approximately 16 years

Duration of Response (DoR)

Timeframe: Up to approximately 16 years

Progression-free Survival 2 (PFS2)

Timeframe: Up to approximately 16 years

Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2026-18-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
May 2024 to December 2026
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Studies having participant population with documented MM, previously treated with at least one prior line of treatment (LOT), and with documented disease progression during or after most recent therapy
  • Studies having any treatment or combination of treatments, including but not restricted to Anti- B-cell maturation antigen (BCMA) anti-drug conjugate (ADC) therapies, Proteasome inhibitors, Immunomodulatory drugs, Corticosteroids, Alkylating agents, Peptide-drug conjugates, Other chemotherapeutic agents, histone deacetylase (HDAC) inhibitors, Anti-CD-38 therapies, Anti-SLAMF7 therapies (CS1/CD319/CRACC), Exportin1 (chromosome region maintenance 1) antagonists
  • Studies involving participants who are treatment-naïve
  • Studies where surgery, palliative treatment, radiotherapy, Autologous stem cell transplant (ASCT) alone are used as interventions
Inclusion and exclusion criteria
Inclusion criteria:

    •Studies having participant population with documented MM, previously treated with at least one prior line of treatment (LOT), and with documented disease progression during or after most recent therapy •Studies having any treatment or combination of treatments, including but not restricted to Anti- B-cell maturation antigen (BCMA) anti-drug conjugate (ADC) therapies, Proteasome inhibitors, Immunomodulatory drugs, Corticosteroids, Alkylating agents, Peptide-drug conjugates, Other chemotherapeutic agents, histone deacetylase (HDAC) inhibitors, Anti-CD-38 therapies, Anti-SLAMF7 therapies (CS1/CD319/CRACC), Exportin1 (chromosome region maintenance 1) antagonists •Studies that report outcomes of interest for the population (RRMM) •Studies with Randomised Control Trial (RCT) trial design •Studies with publications involving full-text peer-reviewed articles, clinical trial records, conference abstracts, relevant GSK clinical reports (if available) •Studies published within the time 2008 to February 2024 •Studies published in English language

Exclusion criteria:

    •Studies involving participants who are treatment-naïve •Studies where surgery, palliative treatment, radiotherapy, Autologous stem cell transplant (ASCT) alone are used as interventions •Studies with dose finding /single intervention comparisons •Studies that do not report outcomes of interest for the population (2L+ RRMM) •Studies with trial designs

    observational studies (retrospective, prospective, cohort studies, longitudinal studies, case series), non-randomised controlled trials, single arm clinical trials, pilot studies, phase I or II a trial reporting only pharmacokinetic or pharmacodynamic outcomes, case studies/case reports, systematic reviews and meta-analyses, in vitro, and animal studies •Studies with publications involving narrative reviews, editorials, protocols, letters, notes or comments •Studies that are published before 2008 •Studies published in non-English language

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
Recruitment complete
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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