Last updated: 04/07/2025 09:32:14

A systematic literature review (SLR) and network meta-analysis (NMA) study to evaluate the efficacy of Belantamab Mafodotin + Pomalidomide + Dexamethasone (B-Pd) versus comparative treatments in participants with second line plus (2L+) relapsed/refractory multiple myeloma (RRMM)

GSK study ID
214933
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: Systematic literature review (SLR) and Network meta-analysis (NMA) of B-Pd versus comparative treatments for patients with 2L+ relapsed/refractory multiple myeloma (RRMM)
Trial description: This is an observational study utilising indirect/mixed treatment comparison design. The aim of the meta-analysis study is to evaluate the efficacy of B-Pd versus comparative treatments for participants identified with 2L+ RRMM.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Progression-free survival (PFS) in Lenalidomide-exposed population

Timeframe: Up to approximately 16 years

Secondary outcomes:

Duration of response (DoR) in Lenalidomide-exposed population

Timeframe: Up to approximately 16 years

Minimum residual disease negativity rate (MRD Negativity) in Lenalidomide-exposed population

Timeframe: Up to approximately 16 years

Overall survival (OS) in Lenalidomide-exposed population

Timeframe: Up to approximately 16 years

Overall response rate (ORR) in Lenalidomide-exposed population

Timeframe: Up to approximately 16 years

Complete response or better (CR+) in Lenalidomide-exposed population

Timeframe: Up to approximately 16 years

Very good partial response or better (VGPR+) in Lenalidomide-exposed population

Timeframe: Up to approximately 16 years

Progression-free survival 2 (PFS2) in Lenalidomide-exposed population

Timeframe: Up to approximately 16 years

PFS in lenalidomide-refractory population

Timeframe: Up to approximately 16 years

DoR in lenalidomide-refractory population

Timeframe: Up to approximately 16 years

MRD Negativity in lenalidomide-refractory population

Timeframe: Up to approximately 16 years

OS in lenalidomide-refractory population

Timeframe: Up to approximately 16 years

ORR in lenalidomide-refractory population

Timeframe: Up to approximately 16 years

CR+ in lenalidomide-refractory population

Timeframe: Up to approximately 16 years

VGPR+ in lenalidomide-refractory population

Timeframe: Up to approximately 16 years

PFS2 in lenalidomide-refractory population

Timeframe: Up to approximately 16 years

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2024-20-12
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)
April 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 Lines of Therapy (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 Lines of Therapy (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 (2L+ 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 period of 2008 to December 2021 •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 following 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 IIa trials 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
2024-20-12
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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