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)
Showing 1 - 6 of 147 Results
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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