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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
Date last updated
24/10/2024
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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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 (PFS)
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Assessment method [1]
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PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis.
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Timepoint [1]
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Up to approximately 41 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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CRR is defined as percentage of participants with a confirmed complete response or better.
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Timepoint [1]
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Up to 73 months
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Secondary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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ORR is defined as percentage of participants with a confirmed partial response or better.
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Timepoint [2]
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Up to 73 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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CBR is defined as percentage of participants with a confirmed minimal response (MR) or better
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Timepoint [3]
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Up to 73 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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DOR is defined as time from first documented evidence of partial response or better until first documented progression or death, whichever occurs first.
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Timepoint [4]
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Up to 73 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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TTR is defined as time from the date of randomization and the first documented evidence of response (PR or better) among participants who achieve partial response or better.
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Timepoint [5]
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Up to 73 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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TTP is defined as time from the date of randomization until the earliest date of documented date of disease progression or death, whichever occurs first.
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Timepoint [6]
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Up to 73 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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OS is defined as 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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0
Up to 73 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]
0
0
Progression-free survival on subsequent line of therapy is defined as time from randomization 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
0
Up to 73 months
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Secondary outcome [9]
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0
Minimal Residual Disease (MRD) Negativity Rate
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Assessment method [9]
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Minimal Residual Disease (MRD) negativity rate is defined as the percentage of participants who are MRD negative status by next generation sequencing (NGS).
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Timepoint [9]
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0
Up to 73 months
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Secondary outcome [10]
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0
Number of Participants With Adverse Events (AEs)
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Assessment method [10]
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0
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
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Timepoint [10]
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0
Up to 73 months
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Secondary outcome [11]
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0
Number of Participants With Clinically Significant Changes in Hematology Parameters
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Assessment method [11]
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Blood samples will be collected for the analysis of hematology parameters.
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Timepoint [11]
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Up to 73 months
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Secondary outcome [12]
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Number of Participants With Clinically Significant Changes in Clinical Chemistry
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Assessment method [12]
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Blood samples will be collected for the analysis of clinical chemistry parameters.
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Timepoint [12]
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Up to 73 months
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Secondary outcome [13]
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Number of Participants With Clinically Significant Changes in Urine Dipstick
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Assessment method [13]
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Urine samples will be collected for the urine dipstick analysis.
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Timepoint [13]
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Up to 73 months
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Secondary outcome [14]
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Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination
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Assessment method [14]
0
0
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Timepoint [14]
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0
Up to 73 months
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Secondary outcome [15]
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0
Plasma Concentrations of Belantamab Mafodotin (Total Antibody) at Indicated Time Points
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Assessment method [15]
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Blood samples will be collected for PK analysis of belantamab mafodotin.
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Timepoint [15]
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Up to 73 months
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Secondary outcome [16]
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0
Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points
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Assessment method [16]
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0
Blood samples will be collected for PK analysis of belantamab mafodotin.
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Timepoint [16]
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Up to 73 months
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Secondary outcome [17]
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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 [17]
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0
Blood samples will be collected for PK analysis of belantamab mafodotin.
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Timepoint [17]
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Up to 73 months
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Secondary outcome [18]
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Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
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Assessment method [18]
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Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be tested in screening assay, and positive samples will be further characterized for antibody titers.
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Timepoint [18]
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Up to 73 months
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Secondary outcome [19]
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0
Titers of ADAs Against Belantamab Mafodotin
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Assessment method [19]
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Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be to be further tested in screening assay, and positive samples will be further to be characterized for antibody titers.
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Timepoint [19]
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Up to 73 months
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Secondary outcome [20]
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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 [20]
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The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.
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Timepoint [20]
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Up to 73 months
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Secondary outcome [21]
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Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by EuropeanOrganization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)
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Assessment method [21]
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The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning \[PF\], role functioning \[RF\], cognitive functioning \[CF\], emotional functioning \[EF\] and social functioning \[SF\]), three symptom scales (fatigue, pain and nausea/vomiting \[N/V\]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss \[AL\] and financial difficulties \[FD\]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
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Timepoint [21]
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Up to 73 months
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Secondary outcome [22]
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Change From Baseline in HRQoL as Measured by EORTC IL52
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Assessment method [22]
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The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. For the EORTC IL52, disease symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score represents a high/healthy level of functioning.
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Timepoint [22]
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Up to 73 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
494
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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 - Ashford
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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 - Ashford
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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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0
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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State/province [2]
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Colorado
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United States of America
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Connecticut
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United States of America
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Kansas
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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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Brazil
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Florianopolis
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Brazil
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State/province [12]
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Joinville
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Brazil
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State/province [13]
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Natal
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Brazil
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State/province [14]
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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SAo Paulo
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Changchun
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China
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Guangzhou
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China
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GuangZhou
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China
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Hangzhou
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China
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Jinan
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China
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Nanjing
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China
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Shenyang
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China
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Suzhou
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China
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Tianjin
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China
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Zhengzhou
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Ostrava
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Czechia
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Praha 2
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France
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Amiens cedex 1
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France
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Caen cedex 9
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France
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Nice cedex 3
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France
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Paris
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France
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Rennes
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Germany
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Duesseldorf
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Germany
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Jena
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Germany
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Koeln
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Germany
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Muenchen
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Germany
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Ulm
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Germany
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Wuerzburg
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Greece
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Alexandroupolis
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Greece
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Athens
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Greece
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Thessaloniki
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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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Tel Hashomer
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Italy
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Bergamo
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Italy
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Bologna
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0
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Italy
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0
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Brescia
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0
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Italy
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0
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Catania
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0
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Italy
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0
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Meldola FC
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0
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Italy
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Milano
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0
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Italy
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Ravenna
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0
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Italy
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Roma
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0
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Italy
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Siena
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Italy
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Torino
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0
Japan
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Aichi
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Japan
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Aomori
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Gifu
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Gunma
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Hyogo
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Japan
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Kanagawa
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Japan
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Kochi
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Japan
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Nagano
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Japan
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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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Pusan
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Seongnam-si Gyeonggi-do
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Korea, Republic of
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Seoul
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Korea, Republic of
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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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Dunedin
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New Zealand
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Takapuna Auckland
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New Zealand
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Wellington
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Poland
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Chorzow
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Nowy Sacz
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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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Moscow
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Russian Federation
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N Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Samara
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Russian Federation
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Saratov
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Russian Federation
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St Petersburg
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Russian Federation
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Ufa
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Spain
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Barcelona
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Spain
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Caceres
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Gijon
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Spain
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L'Hospitalet De Llobrega
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Spain
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Madrid
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Spain
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MOstoles Madrid
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Spain
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Murcia
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Spain
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PamplonaNavarra
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Spain
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Pozuelo De AlarcOn Madr
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Spain
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Salamanca
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United Kingdom
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Bournemouth
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United Kingdom
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Cardiff
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United Kingdom
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Dundee
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Stoke on Trent
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United Kingdom
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Sutton
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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 scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/47/NCT04246047/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/47/NCT04246047/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04246047
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