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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04246047




Registration number
NCT04246047
Ethics application status
Date submitted
27/01/2020
Date registered
29/01/2020
Date last updated
6/04/2021

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
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
Secondary ID [1] 0 0
207503
Universal Trial Number (UTN)
Trial acronym
DREAMM 7
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional(has expanded access)
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival - Time from start of study treatment to the first documented disease progression or death due to any cause, whichever occurs first.
Timepoint [1] 0 0
Up to an average of 34 months
Secondary outcome [1] 0 0
Complete response rate (CRR) - Percentage of participants with a confirmed complete response or better.
Timepoint [1] 0 0
Up to 74 months
Secondary outcome [2] 0 0
Overall response rate (ORR) - Percentage of participants with a confirmed partial response or better.
Timepoint [2] 0 0
Up to 74 months
Secondary outcome [3] 0 0
Duration of response (DoR) after administration of study treatment - Time from first documented evidence of partial response or better to date of first documented progression or death, whichever occurs first.
Timepoint [3] 0 0
Up to 74 months
Secondary outcome [4] 0 0
Time to response (TTR) after administration of study treatment - Time from the start of study treatment to the first documented evidence of response among participants who achieve partial response or better.
Timepoint [4] 0 0
Up to 74 months
Secondary outcome [5] 0 0
Time to Progression (TTP) after administration of study treatment - Time from the start of study treatment until the first documented date of disease progression or death, whichever occurs first.
Timepoint [5] 0 0
Up to 74 months
Secondary outcome [6] 0 0
Overall survival (OS) - Time from randomization to death due to any cause.
Timepoint [6] 0 0
Up to 74 months
Secondary outcome [7] 0 0
Progression-free survival on subsequent line of therapy (PFS2) - Time from start of study treatment to disease progression after initiation of new anti-cancer therapy or death from any cause, whichever occurs first.
Timepoint [7] 0 0
Up to 74 months
Secondary outcome [8] 0 0
Minimal Residual Disease (MRD) negativity rate after administration of study treatment - Percentage of participants who are MRD negative by next-generation sequencing.
Timepoint [8] 0 0
Up to 74 months
Secondary outcome [9] 0 0
Number of participants with adverse events (AEs) - AEs will be collected, including abnormal laboratory parameters.
Timepoint [9] 0 0
Up to 74 months
Secondary outcome [10] 0 0
Number of participants with serious adverse events (SAEs) - SAEs will be collected.
Timepoint [10] 0 0
Up to 74 months
Secondary outcome [11] 0 0
Number of participants with abnormal ocular findings on ophthalmic examination - Ophthalmic examination will assess abnormal findings.
Timepoint [11] 0 0
Up to 74 months
Secondary outcome [12] 0 0
Plasma concentrations of belantamab mafodotin at indicated time points - Plasma concentrations of belantamab mafodotin in Arm A.
Timepoint [12] 0 0
Up to 74 months
Secondary outcome [13] 0 0
Plasma concentrations of total monoclonal antibody (mAb) at indicated time points - Plasma concentrations of total mAb in Arm A.
Timepoint [13] 0 0
Up to 74 months
Secondary outcome [14] 0 0
Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points - Plasma concentrations of cys-mcMMAF in Arm A.
Timepoint [14] 0 0
Up to 74 months
Secondary outcome [15] 0 0
Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin - Plasma concentrations of belantamab mafodotin ADAs in Arm A.
Timepoint [15] 0 0
Up to 74 months
Secondary outcome [16] 0 0
Titers of ADAs against belantamab mafodotin - Titers of ADAs in Arm A.
Timepoint [16] 0 0
Up to 74 months
Secondary outcome [17] 0 0
Change from Baseline in symptoms as measured by Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE) - PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score.
Timepoint [17] 0 0
Baseline and Up to 74 months
Secondary outcome [18] 0 0
Change from Baseline in impacts as measured by PRO-CTCAE - PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trial. Impacts of the side effects will be assessed using PRO-CTCAE score.
Timepoint [18] 0 0
Baseline and Up to 74 months
Secondary outcome [19] 0 0
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) - 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.
Timepoint [19] 0 0
Baseline and Up to 74 months
Secondary outcome [20] 0 0
Change from Baseline in HRQoL as measured by EORTC, 20-Item Multiple Myeloma Module (QLQ-MY20) - EORTC 20-item Multiple Myeloma Module QLQ-MY20 questionnaire: only Disease Symptoms Domain will be administered. A high score represents a high level of symptoms or problems.
Timepoint [20] 0 0
Baseline and Up to 74 months

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [2] 0 0
GSK Investigational Site - Liverpool
Recruitment hospital [3] 0 0
GSK Investigational Site - St Leonards
Recruitment hospital [4] 0 0
GSK Investigational Site - Waratah
Recruitment hospital [5] 0 0
GSK Investigational Site - Wollongong
Recruitment hospital [6] 0 0
GSK Investigational Site - Benowa
Recruitment hospital [7] 0 0
GSK Investigational Site - Herston
Recruitment hospital [8] 0 0
GSK Investigational Site - Kurralta Park
Recruitment hospital [9] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [10] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [11] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [12] 0 0
GSK Investigational Site - Murdoch
Recruitment hospital [13] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4217 - Benowa
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
6150 - Murdoch
Recruitment postcode(s) [13] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
Colorado
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United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
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Ohio
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Utah
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Virginia
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Belgium
State/province [10] 0 0
Brugge
Country [11] 0 0
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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Gent
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Belgium
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Roeselare
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Rio Grande Do Sul
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Santa Catarina
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Jilin
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Ufa
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Cáceres
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Hospitalet de Llobregat (Barcelona)
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Murcia
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Pamplona
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Santiago de Compostela
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Surrey
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Cardiff
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Dundee
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Leicester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT04246047
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04246047