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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04246047
Registration number
NCT04246047
Ethics application status
Date submitted
27/01/2020
Date registered
29/01/2020
Titles & IDs
Public title
Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
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Scientific 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
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Secondary ID [1]
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0
2018-003993-29
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Secondary ID [2]
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207503
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Universal Trial Number (UTN)
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Trial acronym
DREAMM 7
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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0
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Condition category
Condition code
Cancer
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0
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Other cancer types
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Belantamab mafodotin
Treatment: Drugs - Daratumumab
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone
Experimental: Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A) -
Active comparator: Daratumumab and Bortezomib plus Dexamethasone (Arm B) -
Treatment: Drugs: Belantamab mafodotin
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate
Treatment: Drugs: Daratumumab
Anti-cluster of differentiation 38 \[CD-38\] monoclonal antibody
Treatment: Drugs: Bortezomib
Proteasome Inhibitor
Treatment: Drugs: Dexamethasone
Synthetic glucocorticoid with anti-tumor activity
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival
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Assessment method [1]
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Time from the date of randomization until the earliest date of to the first documented disease progression or death due to any cause, whichever occurs first
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Timepoint [1]
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Up to an average of 37 months
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Secondary outcome [1]
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Complete response rate (CRR)
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Assessment method [1]
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Percentage of participants with a confirmed complete response or better.
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Timepoint [1]
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Up to 74 months
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Secondary outcome [2]
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0
Overall response rate (ORR)
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Assessment method [2]
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Percentage of participants with a confirmed partial response or better.
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Timepoint [2]
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0
Up to 74 months
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Secondary outcome [3]
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Clinical Benefit Rate (CBR)
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Assessment method [3]
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Percentage of participants with a confirmed partial response or better
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Timepoint [3]
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Up to 74 months
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Secondary outcome [4]
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Duration of response (DoR)
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Assessment method [4]
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Time from first documented evidence of partial response or better to date of first documented progression or death, whichever occurs first.
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Timepoint [4]
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Up to 74 months
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Secondary outcome [5]
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Time to response (TTR)
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Assessment method [5]
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Time from the date of randomization and the first documented evidence of response among participants who achieve partial response or better.
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Timepoint [5]
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Up to 74 months
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Secondary outcome [6]
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Time to Progression (TTP)
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Assessment method [6]
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Time from the date of randomization until the first documented date of disease progression or death, whichever occurs first.
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Timepoint [6]
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Up to 74 months
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Secondary outcome [7]
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Overall survival (OS)
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Assessment method [7]
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Time from the date of randomization until the date of death due to any cause.
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Timepoint [7]
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Up to 74 months
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Secondary outcome [8]
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Progression-free survival on subsequent line of therapy (PFS2)
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Assessment method [8]
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Time from start of study treatment to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever occurs first. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier .
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Timepoint [8]
0
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Up to 74 months
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Secondary outcome [9]
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Minimal Residual Disease (MRD) negativity rate
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Assessment method [9]
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Minimal Residual Disease (MRD) negativity rate, defined as the percentage of participants who are MRD negative by next generation sequencing (NGS)
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Timepoint [9]
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Up to 74 months
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Secondary outcome [10]
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Number of participants with adverse events (AEs)
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Assessment method [10]
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AEs will be collected, including abnormal laboratory parameters.
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Timepoint [10]
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Up to 74 months
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Secondary outcome [11]
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Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
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Assessment method [11]
0
0
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Timepoint [11]
0
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Up to 74 months
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Secondary outcome [12]
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Number of participants with abnormal ocular findings on ophthalmic examination
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Assessment method [12]
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Ophthalmic examination will assess abnormal findings.
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Timepoint [12]
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Up to 74 months
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Secondary outcome [13]
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Plasma concentrations of belantamab mafodotin at indicated time points
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Assessment method [13]
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Plasma concentrations of belantamab mafodotin in Arm A.
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Timepoint [13]
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Up to 74 months
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Secondary outcome [14]
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Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points
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Assessment method [14]
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Plasma concentrations of cys-mcMMAF in Arm A.
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Timepoint [14]
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Up to 74 months
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Secondary outcome [15]
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Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin
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Assessment method [15]
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Plasma concentrations of belantamab mafodotin ADAs in Arm A.
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Timepoint [15]
0
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Up to 74 months
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Secondary outcome [16]
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Titers of ADAs against belantamab mafodotin
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Assessment method [16]
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Titers of ADAs in Arm A.
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Timepoint [16]
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Up to 74 months
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Secondary outcome [17]
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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)
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Assessment method [17]
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PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score..
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Timepoint [17]
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Up to 74 months
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Secondary outcome [18]
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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)
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Assessment method [18]
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EORTC Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.
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Timepoint [18]
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Baseline and Up to 74 months
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Secondary outcome [19]
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Change from Baseline in HRQoL as measured by EORTC IL52, 20-Item Multiple Myeloma Module (QLQ-MY20)
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Assessment method [19]
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EORTC IL52 Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.
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Timepoint [19]
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Baseline and Up to 74 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/05/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
19/06/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
571
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Camperdown
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Recruitment hospital [2]
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GSK Investigational Site - Liverpool
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Recruitment hospital [3]
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GSK Investigational Site - St Leonards
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Recruitment hospital [4]
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GSK Investigational Site - Waratah
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Recruitment hospital [5]
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GSK Investigational Site - Wollongong
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Recruitment hospital [6]
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GSK Investigational Site - Benowa
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Recruitment hospital [7]
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GSK Investigational Site - Herston
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Recruitment hospital [8]
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GSK Investigational Site - Kurralta Park
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Recruitment hospital [9]
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GSK Investigational Site - Box Hill
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Recruitment hospital [10]
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GSK Investigational Site - Heidelberg
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Recruitment hospital [11]
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GSK Investigational Site - Melbourne
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Recruitment hospital [12]
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GSK Investigational Site - Murdoch
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Recruitment hospital [13]
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GSK Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2170 - Liverpool
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment postcode(s) [4]
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2298 - Waratah
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Recruitment postcode(s) [5]
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2500 - Wollongong
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Recruitment postcode(s) [6]
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4217 - Benowa
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Recruitment postcode(s) [7]
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4029 - Herston
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Recruitment postcode(s) [8]
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5037 - Kurralta Park
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Recruitment postcode(s) [9]
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3128 - Box Hill
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Recruitment postcode(s) [10]
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3084 - Heidelberg
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Recruitment postcode(s) [11]
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3004 - Melbourne
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Recruitment postcode(s) [12]
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6150 - Murdoch
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Recruitment postcode(s) [13]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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Colorado
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United States of America
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Kansas
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Ohio
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United States of America
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Texas
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United States of America
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Virginia
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Belgium
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Brussel
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Belgium
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Bruxelles
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Belgium
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State/province [9]
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Gent
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Belgium
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State/province [10]
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Roeselare
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Country [11]
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Brazil
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State/province [11]
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Rio Grande Do Norte
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Brazil
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State/province [12]
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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Rio de Janeiro
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Brazil
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São Paulo
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Alberta
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Ontario
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Guangdong
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Jiangsu
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China
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Jilin
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China
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Shandong
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China
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Zhejiang
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China
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Beijing
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China
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GuangZhou
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China
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China
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Shenyang
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China
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Tianjin
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China
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Wuhan
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Zhengzhou
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Brno
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Hradec Kralove
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Ostrava
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Praha 2
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Amiens cedex 1
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Caen cedex 9
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France
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Nice
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France
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Paris cedex 13
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France
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Rennes cedex 9
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Bayern
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Thueringen
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Alexandroupolis
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Athens
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Tel Aviv
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Israel
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Lazio
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Italy
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Italy
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Aomori
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Chiba
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Ehime
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Fukuoka
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Japan
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Fukushima
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Japan
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Gifu
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Japan
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Gunma
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Japan
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Hokkaido
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Hyogo
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Kanagawa
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Kyoto
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Nagano
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Okayama
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Japan
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Osaka
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Japan
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Shizuoka
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Korea, Republic of
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Busan
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Korea, Republic of
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Seongnam-si, Gyeonggi-do
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Korea, Republic of
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Seoul
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Ulsan
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Netherlands
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Dordrecht
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Groningen
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Christchurch
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Newtown
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New Zealand
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Takapuna, Auckland
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Poland
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State/province [84]
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Chorzow
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Country [85]
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Poland
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State/province [85]
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Krakow
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Country [86]
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Poland
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State/province [86]
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Lodz
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Poland
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Lublin
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Country [88]
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Poland
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State/province [88]
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Nowy Sacz
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Country [89]
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Poland
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Poznan
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Poland
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Warszawa
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Russian Federation
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State/province [91]
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Moscow
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Country [92]
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Russian Federation
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State/province [92]
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Nizhniy Novgorod
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Country [93]
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Russian Federation
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State/province [93]
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Novosibirsk
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Country [94]
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Russian Federation
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State/province [94]
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Samara
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Country [95]
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Russian Federation
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State/province [95]
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Saratov
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Country [96]
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Russian Federation
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State/province [96]
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St'Petersburg
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Country [97]
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Russian Federation
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State/province [97]
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St. Petersburg
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Country [98]
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Russian Federation
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State/province [98]
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Ufa
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Country [99]
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Spain
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State/province [99]
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Badalona
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Country [100]
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Spain
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State/province [100]
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Barcelona
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Country [101]
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Spain
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State/province [101]
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Cáceres
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Country [102]
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Spain
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State/province [102]
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Gijón
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Spain
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State/province [103]
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Madrid
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Spain
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Murcia
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Country [105]
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Spain
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State/province [105]
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Móstoles
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Country [106]
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Spain
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State/province [106]
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Pamplona
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Country [107]
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Spain
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State/province [107]
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Pozuelo De Alarcón/Madrid
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Country [108]
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Spain
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State/province [108]
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Salamanca
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Country [109]
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United Kingdom
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State/province [109]
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Staffordshire
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Country [110]
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United Kingdom
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State/province [110]
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Surrey
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Country [111]
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United Kingdom
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State/province [111]
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Bournemouth
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Country [112]
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United Kingdom
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State/province [112]
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Cardiff
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Country [113]
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United Kingdom
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State/province [113]
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Dundee
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Country [114]
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United Kingdom
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State/province [114]
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Leicester
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Country [115]
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United Kingdom
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State/province [115]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04246047
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
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Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04246047