Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04246047
Registration number
NCT04246047
Ethics application status
Date submitted
27/01/2020
Date registered
29/01/2020
Date last updated
13/12/2023
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
Query!
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
Query!
Secondary ID [1]
0
0
2018-003993-29
Query!
Secondary ID [2]
0
0
207503
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
DREAMM 7
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Other cancer types
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-free survival
Query!
Assessment method [1]
0
0
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
Query!
Timepoint [1]
0
0
Up to an average of 37 months
Query!
Secondary outcome [1]
0
0
Complete response rate (CRR)
Query!
Assessment method [1]
0
0
Percentage of participants with a confirmed complete response or better.
Query!
Timepoint [1]
0
0
Up to 74 months
Query!
Secondary outcome [2]
0
0
Overall response rate (ORR)
Query!
Assessment method [2]
0
0
Percentage of participants with a confirmed partial response or better.
Query!
Timepoint [2]
0
0
Up to 74 months
Query!
Secondary outcome [3]
0
0
Clinical Benefit Rate (CBR)
Query!
Assessment method [3]
0
0
Percentage of participants with a confirmed partial response or better
Query!
Timepoint [3]
0
0
Up to 74 months
Query!
Secondary outcome [4]
0
0
Duration of response (DoR)
Query!
Assessment method [4]
0
0
Time from first documented evidence of partial response or better to date of first documented progression or death, whichever occurs first.
Query!
Timepoint [4]
0
0
Up to 74 months
Query!
Secondary outcome [5]
0
0
Time to response (TTR)
Query!
Assessment method [5]
0
0
Time from the date of randomization and the first documented evidence of response among participants who achieve partial response or better.
Query!
Timepoint [5]
0
0
Up to 74 months
Query!
Secondary outcome [6]
0
0
Time to Progression (TTP)
Query!
Assessment method [6]
0
0
Time from the date of randomization until the first documented date of disease progression or death, whichever occurs first.
Query!
Timepoint [6]
0
0
Up to 74 months
Query!
Secondary outcome [7]
0
0
Overall survival (OS)
Query!
Assessment method [7]
0
0
Time from the date of randomization until the date of death due to any cause.
Query!
Timepoint [7]
0
0
Up to 74 months
Query!
Secondary outcome [8]
0
0
Progression-free survival on subsequent line of therapy (PFS2)
Query!
Assessment method [8]
0
0
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 .
Query!
Timepoint [8]
0
0
Up to 74 months
Query!
Secondary outcome [9]
0
0
Minimal Residual Disease (MRD) negativity rate
Query!
Assessment method [9]
0
0
Minimal Residual Disease (MRD) negativity rate, defined as the percentage of participants who are MRD negative by next generation sequencing (NGS)
Query!
Timepoint [9]
0
0
Up to 74 months
Query!
Secondary outcome [10]
0
0
Number of participants with adverse events (AEs)
Query!
Assessment method [10]
0
0
AEs will be collected, including abnormal laboratory parameters.
Query!
Timepoint [10]
0
0
Up to 74 months
Query!
Secondary outcome [11]
0
0
Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Up to 74 months
Query!
Secondary outcome [12]
0
0
Number of participants with abnormal ocular findings on ophthalmic examination
Query!
Assessment method [12]
0
0
Ophthalmic examination will assess abnormal findings.
Query!
Timepoint [12]
0
0
Up to 74 months
Query!
Secondary outcome [13]
0
0
Plasma concentrations of belantamab mafodotin at indicated time points
Query!
Assessment method [13]
0
0
Plasma concentrations of belantamab mafodotin in Arm A.
Query!
Timepoint [13]
0
0
Up to 74 months
Query!
Secondary outcome [14]
0
0
Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points
Query!
Assessment method [14]
0
0
Plasma concentrations of cys-mcMMAF in Arm A.
Query!
Timepoint [14]
0
0
Up to 74 months
Query!
Secondary outcome [15]
0
0
Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin
Query!
Assessment method [15]
0
0
Plasma concentrations of belantamab mafodotin ADAs in Arm A.
Query!
Timepoint [15]
0
0
Up to 74 months
Query!
Secondary outcome [16]
0
0
Titers of ADAs against belantamab mafodotin
Query!
Assessment method [16]
0
0
Titers of ADAs in Arm A.
Query!
Timepoint [16]
0
0
Up to 74 months
Query!
Secondary outcome [17]
0
0
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)
Query!
Assessment method [17]
0
0
PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score..
Query!
Timepoint [17]
0
0
Up to 74 months
Query!
Secondary outcome [18]
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)
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
Baseline and Up to 74 months
Query!
Secondary outcome [19]
0
0
Change from Baseline in HRQoL as measured by EORTC IL52, 20-Item Multiple Myeloma Module (QLQ-MY20)
Query!
Assessment method [19]
0
0
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.
Query!
Timepoint [19]
0
0
Baseline and Up to 74 months
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
7/05/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
19/06/2026
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
571
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Camperdown
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Liverpool
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - St Leonards
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Waratah
Query!
Recruitment hospital [5]
0
0
GSK Investigational Site - Wollongong
Query!
Recruitment hospital [6]
0
0
GSK Investigational Site - Benowa
Query!
Recruitment hospital [7]
0
0
GSK Investigational Site - Herston
Query!
Recruitment hospital [8]
0
0
GSK Investigational Site - Kurralta Park
Query!
Recruitment hospital [9]
0
0
GSK Investigational Site - Box Hill
Query!
Recruitment hospital [10]
0
0
GSK Investigational Site - Heidelberg
Query!
Recruitment hospital [11]
0
0
GSK Investigational Site - Melbourne
Query!
Recruitment hospital [12]
0
0
GSK Investigational Site - Murdoch
Query!
Recruitment hospital [13]
0
0
GSK Investigational Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [3]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [4]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [5]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [6]
0
0
4217 - Benowa
Query!
Recruitment postcode(s) [7]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [8]
0
0
5037 - Kurralta Park
Query!
Recruitment postcode(s) [9]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [10]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [11]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [12]
0
0
6150 - Murdoch
Query!
Recruitment postcode(s) [13]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Kansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Ohio
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Texas
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Virginia
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
Brussel
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Bruxelles
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Gent
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Roeselare
Query!
Country [11]
0
0
Brazil
Query!
State/province [11]
0
0
Rio Grande Do Norte
Query!
Country [12]
0
0
Brazil
Query!
State/province [12]
0
0
Rio Grande Do Sul
Query!
Country [13]
0
0
Brazil
Query!
State/province [13]
0
0
Santa Catarina
Query!
Country [14]
0
0
Brazil
Query!
State/province [14]
0
0
Rio de Janeiro
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
São Paulo
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Alberta
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Ontario
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Quebec
Query!
Country [19]
0
0
China
Query!
State/province [19]
0
0
Guangdong
Query!
Country [20]
0
0
China
Query!
State/province [20]
0
0
Jiangsu
Query!
Country [21]
0
0
China
Query!
State/province [21]
0
0
Jilin
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Shandong
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Zhejiang
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Beijing
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
GuangZhou
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Jiang Su Province
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Shenyang
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Tianjin
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Wuhan
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Zhengzhou
Query!
Country [31]
0
0
Czechia
Query!
State/province [31]
0
0
Brno
Query!
Country [32]
0
0
Czechia
Query!
State/province [32]
0
0
Hradec Kralove
Query!
Country [33]
0
0
Czechia
Query!
State/province [33]
0
0
Ostrava
Query!
Country [34]
0
0
Czechia
Query!
State/province [34]
0
0
Praha 2
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Amiens cedex 1
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Caen cedex 9
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Nice
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Paris cedex 13
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Rennes cedex 9
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Baden-Wuerttemberg
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Bayern
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Nordrhein-Westfalen
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Thueringen
Query!
Country [44]
0
0
Greece
Query!
State/province [44]
0
0
Alexandroupolis
Query!
Country [45]
0
0
Greece
Query!
State/province [45]
0
0
Athens
Query!
Country [46]
0
0
Greece
Query!
State/province [46]
0
0
Thessaloniki
Query!
Country [47]
0
0
Israel
Query!
State/province [47]
0
0
Jerusalem
Query!
Country [48]
0
0
Israel
Query!
State/province [48]
0
0
Kfar Saba
Query!
Country [49]
0
0
Israel
Query!
State/province [49]
0
0
Tel Aviv
Query!
Country [50]
0
0
Israel
Query!
State/province [50]
0
0
Tel Hashomer
Query!
Country [51]
0
0
Italy
Query!
State/province [51]
0
0
Emilia-Romagna
Query!
Country [52]
0
0
Italy
Query!
State/province [52]
0
0
Lazio
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Lombardia
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Piemonte
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Sicilia
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Toscana
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Aichi
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Aomori
Query!
Country [59]
0
0
Japan
Query!
State/province [59]
0
0
Chiba
Query!
Country [60]
0
0
Japan
Query!
State/province [60]
0
0
Ehime
Query!
Country [61]
0
0
Japan
Query!
State/province [61]
0
0
Fukuoka
Query!
Country [62]
0
0
Japan
Query!
State/province [62]
0
0
Fukushima
Query!
Country [63]
0
0
Japan
Query!
State/province [63]
0
0
Gifu
Query!
Country [64]
0
0
Japan
Query!
State/province [64]
0
0
Gunma
Query!
Country [65]
0
0
Japan
Query!
State/province [65]
0
0
Hokkaido
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Hyogo
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Kanagawa
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Kochi
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Kyoto
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Nagano
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Okayama
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Osaka
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Shizuoka
Query!
Country [74]
0
0
Korea, Republic of
Query!
State/province [74]
0
0
Busan
Query!
Country [75]
0
0
Korea, Republic of
Query!
State/province [75]
0
0
Seongnam-si, Gyeonggi-do
Query!
Country [76]
0
0
Korea, Republic of
Query!
State/province [76]
0
0
Seoul
Query!
Country [77]
0
0
Korea, Republic of
Query!
State/province [77]
0
0
Ulsan
Query!
Country [78]
0
0
Netherlands
Query!
State/province [78]
0
0
Dordrecht
Query!
Country [79]
0
0
Netherlands
Query!
State/province [79]
0
0
Groningen
Query!
Country [80]
0
0
New Zealand
Query!
State/province [80]
0
0
Christchurch
Query!
Country [81]
0
0
New Zealand
Query!
State/province [81]
0
0
Dunedin
Query!
Country [82]
0
0
New Zealand
Query!
State/province [82]
0
0
Newtown
Query!
Country [83]
0
0
New Zealand
Query!
State/province [83]
0
0
Takapuna, Auckland
Query!
Country [84]
0
0
Poland
Query!
State/province [84]
0
0
Chorzow
Query!
Country [85]
0
0
Poland
Query!
State/province [85]
0
0
Krakow
Query!
Country [86]
0
0
Poland
Query!
State/province [86]
0
0
Lodz
Query!
Country [87]
0
0
Poland
Query!
State/province [87]
0
0
Lublin
Query!
Country [88]
0
0
Poland
Query!
State/province [88]
0
0
Nowy Sacz
Query!
Country [89]
0
0
Poland
Query!
State/province [89]
0
0
Poznan
Query!
Country [90]
0
0
Poland
Query!
State/province [90]
0
0
Warszawa
Query!
Country [91]
0
0
Russian Federation
Query!
State/province [91]
0
0
Moscow
Query!
Country [92]
0
0
Russian Federation
Query!
State/province [92]
0
0
Nizhniy Novgorod
Query!
Country [93]
0
0
Russian Federation
Query!
State/province [93]
0
0
Novosibirsk
Query!
Country [94]
0
0
Russian Federation
Query!
State/province [94]
0
0
Samara
Query!
Country [95]
0
0
Russian Federation
Query!
State/province [95]
0
0
Saratov
Query!
Country [96]
0
0
Russian Federation
Query!
State/province [96]
0
0
St'Petersburg
Query!
Country [97]
0
0
Russian Federation
Query!
State/province [97]
0
0
St. Petersburg
Query!
Country [98]
0
0
Russian Federation
Query!
State/province [98]
0
0
Ufa
Query!
Country [99]
0
0
Spain
Query!
State/province [99]
0
0
Badalona
Query!
Country [100]
0
0
Spain
Query!
State/province [100]
0
0
Barcelona
Query!
Country [101]
0
0
Spain
Query!
State/province [101]
0
0
Cáceres
Query!
Country [102]
0
0
Spain
Query!
State/province [102]
0
0
Gijón
Query!
Country [103]
0
0
Spain
Query!
State/province [103]
0
0
Madrid
Query!
Country [104]
0
0
Spain
Query!
State/province [104]
0
0
Murcia
Query!
Country [105]
0
0
Spain
Query!
State/province [105]
0
0
Móstoles
Query!
Country [106]
0
0
Spain
Query!
State/province [106]
0
0
Pamplona
Query!
Country [107]
0
0
Spain
Query!
State/province [107]
0
0
Pozuelo De Alarcón/Madrid
Query!
Country [108]
0
0
Spain
Query!
State/province [108]
0
0
Salamanca
Query!
Country [109]
0
0
United Kingdom
Query!
State/province [109]
0
0
Staffordshire
Query!
Country [110]
0
0
United Kingdom
Query!
State/province [110]
0
0
Surrey
Query!
Country [111]
0
0
United Kingdom
Query!
State/province [111]
0
0
Bournemouth
Query!
Country [112]
0
0
United Kingdom
Query!
State/province [112]
0
0
Cardiff
Query!
Country [113]
0
0
United Kingdom
Query!
State/province [113]
0
0
Dundee
Query!
Country [114]
0
0
United Kingdom
Query!
State/province [114]
0
0
Leicester
Query!
Country [115]
0
0
United Kingdom
Query!
State/province [115]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
GlaxoSmithKline
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04246047
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
GlaxoSmithKline
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04246047
Download to PDF