Last updated: 05/08/2025 17:00:19

Japan Expansion Cohort: Evaluation of efficacy and safety of belantamab mafodotin, bortezomib and dexamethasone versus daratumumab, bortezomib and dexamethasone in participants with relapsed/refractory multiple myelomaDREAMM 7

GSK study ID
207503-JPN
See study documents
Clinicaltrials.gov ID
NCT06868667
See results summary
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: DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared with the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants with Relapsed/Refractory Multiple Myeloma
Trial description: This study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the Japanese participants with relapsed refractory multiple myeloma.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Progression-free survival (PFS)

Timeframe: Up to approximately 32 months

Secondary outcomes:

Overall survival (OS)

Timeframe: Up to 59 months

Duration of response (DoR)

Timeframe: Up to 59 months

Minimal Residual Disease (MRD) negativity rate

Timeframe: Up to 59 months

Complete response rate (CRR)

Timeframe: Up to 59 months

Overall response rate (ORR)

Timeframe: Up to 59 months

Clinical Benefit Rate (CBR)

Timeframe: Up to 59 months

Time to response (TTR)

Timeframe: Up to 59 months

Time to Progression (TTP)

Timeframe: Up to 59 months

Progression-free survival on subsequent line of therapy (PFS2)

Timeframe: Up to 59 months

Number of participants with adverse events (AEs)

Timeframe: Up to 59 months

Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters

Timeframe: Up to 59 months

Number of participants with abnormal ocular findings on ophthalmic examination

Timeframe: Up to 59 months

Plasma concentrations of belantamab mafodotin

Timeframe: Up to 59 months

Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF)

Timeframe: Up to 59 months

Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin

Timeframe: Up to 59 months

Titers of ADAs against belantamab mafodotin

Timeframe: Up to 59 months

Number of Participants with Maximum post-baseline change from baseline in individual items of Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE)

Timeframe: Up to 59 months

Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30)

Timeframe: Up to 59 months

Change from Baseline in HRQoL as measured by EORTC IL52, 20-Item Multiple Myeloma Module (QLQ-MY20)

Timeframe: Up to 59 months

Interventions:
  • Drug: Belantamab mafodotin
  • Drug: Daratumumab
  • Drug: Bortezomib
  • Drug: Dexamethasone
    • Enrollment:
    24
    Primary completion date:
    2024-03-04
    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)
    July 2021 to June 2026
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria.
    • Previously treated with at least 1 prior line of multiple myeloma (MM) therapy and must have documented disease progression during or after their most recent therapy.
    • Intolerant to daratumumab.
    • Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment).
    Inclusion and exclusion criteria
    Inclusion criteria:

      Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria.

      • Previously treated with at least 1 prior line of multiple myeloma (MM) therapy and must have documented disease progression during or after their most recent therapy.
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
      • Must have at least 1 aspect of measurable disease, defined as one of the following; 1. Urine M-protein excretion >=200 mg per 24-hour, or 2. Serum M-protein concentration >=0.5 grams per deciliter (g/dL), or 3. Serum free light chain (FLC) assay: involved FLC level >=10 mg per dL (>=100 mg per liter) and an abnormal serum free light chain ratio (<0.26 or >1.65).
      • All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be <=Grade 1 at the time of enrollment, except for alopecia.
      • Adequate organ function
    Exclusion criteria:

      Intolerant to daratumumab.

      • Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment).
      • Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed.
      • Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.
      • Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy.
      • Prior allogenic stem cell transplant.
      • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies.
      • Corneal epithelial disease

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Matsuyama, Japan
    Status
    Recruitment Complete
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    Location
    GSK Investigational Site
    Shibukawa, Japan
    Status
    Recruitment Complete
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    Location
    GSK Investigational Site
    Okayama, Japan
    Status
    Recruitment Complete
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    Location
    GSK Investigational Site
    Nagoya, Japan
    Status
    Recruitment Complete
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    Location
    GSK Investigational Site
    Toyohashi, Japan
    Status
    Recruitment Complete
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    Location
    GSK Investigational Site
    Himeji, Japan
    Status
    Recruitment Complete
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    Showing 1 - 6 of 16 Results

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Recruitment complete
    Actual primary completion date
    2024-03-04
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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