Last updated: 04/21/2025 18:10:09
Evaluation of efficacy and safety of belantamab mafodotin, bortezomib and dexamethasone versus daratumumab, bortezomib and dexamethasone in participants with relapsed/refractory multiple myelomaDREAMM 7
EudraCT ID
EU CT Number
Trial status
Recruitment complete
Recruitment complete
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 is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Progression-free survival
Timeframe: Up to an average of 37 months
Secondary outcomes:
Complete response rate (CRR)
Timeframe: Up to 74 months
Overall response rate (ORR)
Timeframe: Up to 74 months
Clinical Benefit Rate (CBR)
Timeframe: Up to 74 months
Duration of response (DoR)
Timeframe: Up to 74 months
Time to response (TTR)
Timeframe: Up to 74 months
Time to Progression (TTP)
Timeframe: Up to 74 months
Overall survival (OS)
Timeframe: Up to 74 months
Progression-free survival on subsequent line of therapy (PFS2)
Timeframe: Up to 74 months
Minimal Residual Disease (MRD) negativity rate
Timeframe: Up to 74 months
Number of participants with adverse events (AEs)
Timeframe: Up to 74 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Timeframe: Up to 74 months
Number of participants with abnormal ocular findings on ophthalmic examination
Timeframe: Up to 74 months
Plasma concentrations of belantamab mafodotin at indicated time points
Timeframe: Up to 74 months
Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points
Timeframe: Up to 74 months
Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin
Timeframe: Up to 74 months
Titers of ADAs against belantamab mafodotin
Timeframe: Up to 74 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 74 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: Baseline and Up to 74 months
Change from Baseline in HRQoL as measured by EORTC IL52, 20-Item Multiple Myeloma Module (QLQ-MY20)
Timeframe: Baseline and Up to 74 months
Interventions:
Enrollment:
494
Primary completion date:
2023-02-10
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 2020 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; a) Urine M-protein excretion >=200 mg per 24-hour, or b) Serum M-protein concentration >=0.5 grams per deciliter (g/dL), or c) 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
GSK Investigational Site
Pozuelo de AlarcOn Madr, Spain, 28223
Status
Recruitment Complete
Location
GSK Investigational Site
Camperdown, NSW, Australia, 2050
Status
Recruitment Complete
Location
GSK Investigational Site
L'Hospitalet de Llobrega, Spain, 08908
Status
Recruitment Complete
Location
GSK Investigational Site
Bournemouth, United Kingdom, BH7 7DW
Status
Recruitment Complete
Location
GSK Investigational Site
Denver, CO, United States, 80218
Status
Recruitment Complete
Location
GSK Investigational Site
St Leonards, NSW, Australia, 2065
Status
Recruitment Complete
Location
GSK Investigational Site
Fairfield, OH, United States, 45242
Status
Recruitment Complete
Location
GSK Investigational Site
Heidelberg, VIC, Australia, 3084
Status
Recruitment Complete
Location
GSK Investigational Site
Takapuna Auckland, New Zealand, 1309
Status
Recruitment Complete
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 05
Status
Recruitment Complete
Location
GSK Investigational Site
Saint-Petersburg, Russia, 197 089
Status
Recruitment Complete
Location
GSK Investigational Site
Kansas City, KS, United States, 66205
Status
Recruitment Complete
Location
GSK Investigational Site
Cardiff, United Kingdom, CF14 4XW
Status
Recruitment Complete
Location
GSK Investigational Site
Stoke on Trent, United Kingdom, ST4 6QG
Status
Recruitment Complete
Location
GSK Investigational Site
Rio de Janeiro, Brazil, 22775001
Status
Recruitment Complete
Location
GSK Investigational Site
Florianopolis, Brazil, 88020-210
Status
Recruitment Complete
Location
GSK Investigational Site
Leicester, United Kingdom, LE1 5WW
Status
Recruitment Complete
Location
GSK Investigational Site
Seongnam-si Gyeonggi-do, South Korea, 13620
Status
Recruitment Complete
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
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
2023-02-10
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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