Last updated: 07/04/2025 07:20:13

A study to evaluate the effectiveness of belantamab mafodotin + bortezomib + dexamethasone (B-Vd) versus comparative treatments for participants with one or more prior lines (2L+) relapsed/refractory multiple myeloma (RRMM)

GSK study ID
221835
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 treatment comparison (MAIC) of B-Vd versus comparative treatments for patients with 2L+ relapsed/refractory multiple myeloma (RRMM)
Trial description: This is a non-interventional study utilising indirect treatment comparison (ITC) analyses to evaluate the effectiveness of B-Vd versus comparative treatments in 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)

Timeframe: Up to approximately 15 years

Overall response rate (ORR)

Timeframe: Up to approximately 15 years

Very good partial response or better (VGPR+)

Timeframe: Up to approximately 15 years

Complete response or better (CR+)

Timeframe: Up to approximately 15 years

Minimal residual disease (MRD) negativity rate

Timeframe: Up to approximately 15 years

Duration of Response (DoR)

Timeframe: Up to approximately 15 years

Number of participants with discontinuation due to adverse events (DDTAE)

Timeframe: Up to approximately 15 years

Progression-free Survival 2 (PFS2)

Timeframe: Up to approximately 15 years

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
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)
March 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 multiple myeloma (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

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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