Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
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
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
2018-003993-29
Secondary ID [2] 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
Timepoint [1] 0 0
Up to an average of 37 months
Secondary outcome [1] 0 0
Complete response rate (CRR)
Timepoint [1] 0 0
Up to 74 months
Secondary outcome [2] 0 0
Overall response rate (ORR)
Timepoint [2] 0 0
Up to 74 months
Secondary outcome [3] 0 0
Clinical Benefit Rate (CBR)
Timepoint [3] 0 0
Up to 74 months
Secondary outcome [4] 0 0
Duration of response (DoR)
Timepoint [4] 0 0
Up to 74 months
Secondary outcome [5] 0 0
Time to response (TTR)
Timepoint [5] 0 0
Up to 74 months
Secondary outcome [6] 0 0
Time to Progression (TTP)
Timepoint [6] 0 0
Up to 74 months
Secondary outcome [7] 0 0
Overall survival (OS)
Timepoint [7] 0 0
Up to 74 months
Secondary outcome [8] 0 0
Progression-free survival on subsequent line of therapy (PFS2)
Timepoint [8] 0 0
Up to 74 months
Secondary outcome [9] 0 0
Minimal Residual Disease (MRD) negativity rate
Timepoint [9] 0 0
Up to 74 months
Secondary outcome [10] 0 0
Number of participants with adverse events (AEs)
Timepoint [10] 0 0
Up to 74 months
Secondary outcome [11] 0 0
Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Timepoint [11] 0 0
Up to 74 months
Secondary outcome [12] 0 0
Number of participants with abnormal ocular findings on ophthalmic examination
Timepoint [12] 0 0
Up to 74 months
Secondary outcome [13] 0 0
Plasma concentrations of belantamab mafodotin at indicated time points
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
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
Timepoint [15] 0 0
Up to 74 months
Secondary outcome [16] 0 0
Titers of ADAs against belantamab mafodotin
Timepoint [16] 0 0
Up to 74 months
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)
Timepoint [17] 0 0
Up to 74 months
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)
Timepoint [18] 0 0
Baseline and Up to 74 months
Secondary outcome [19] 0 0
Change from Baseline in HRQoL as measured by EORTC IL52, 20-Item Multiple Myeloma Module (QLQ-MY20)
Timepoint [19] 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
Sex
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/06/2026
Actual
Sample size
Target
Accrual to date
Final
571
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Belgium
State/province [7] 0 0
Brussel
Country [8] 0 0
Belgium
State/province [8] 0 0
Bruxelles
Country [9] 0 0
Belgium
State/province [9] 0 0
Gent
Country [10] 0 0
Belgium
State/province [10] 0 0
Roeselare
Country [11] 0 0
Brazil
State/province [11] 0 0
Rio Grande Do Norte
Country [12] 0 0
Brazil
State/province [12] 0 0
Rio Grande Do Sul
Country [13] 0 0
Brazil
State/province [13] 0 0
Santa Catarina
Country [14] 0 0
Brazil
State/province [14] 0 0
Rio de Janeiro
Country [15] 0 0
Brazil
State/province [15] 0 0
São Paulo
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
China
State/province [19] 0 0
Guangdong
Country [20] 0 0
China
State/province [20] 0 0
Jiangsu
Country [21] 0 0
China
State/province [21] 0 0
Jilin
Country [22] 0 0
China
State/province [22] 0 0
Shandong
Country [23] 0 0
China
State/province [23] 0 0
Zhejiang
Country [24] 0 0
China
State/province [24] 0 0
Beijing
Country [25] 0 0
China
State/province [25] 0 0
GuangZhou
Country [26] 0 0
China
State/province [26] 0 0
Jiang Su Province
Country [27] 0 0
China
State/province [27] 0 0
Shenyang
Country [28] 0 0
China
State/province [28] 0 0
Tianjin
Country [29] 0 0
China
State/province [29] 0 0
Wuhan
Country [30] 0 0
China
State/province [30] 0 0
Zhengzhou
Country [31] 0 0
Czechia
State/province [31] 0 0
Brno
Country [32] 0 0
Czechia
State/province [32] 0 0
Hradec Kralove
Country [33] 0 0
Czechia
State/province [33] 0 0
Ostrava
Country [34] 0 0
Czechia
State/province [34] 0 0
Praha 2
Country [35] 0 0
France
State/province [35] 0 0
Amiens cedex 1
Country [36] 0 0
France
State/province [36] 0 0
Caen cedex 9
Country [37] 0 0
France
State/province [37] 0 0
Nice
Country [38] 0 0
France
State/province [38] 0 0
Paris cedex 13
Country [39] 0 0
France
State/province [39] 0 0
Rennes cedex 9
Country [40] 0 0
Germany
State/province [40] 0 0
Baden-Wuerttemberg
Country [41] 0 0
Germany
State/province [41] 0 0
Bayern
Country [42] 0 0
Germany
State/province [42] 0 0
Nordrhein-Westfalen
Country [43] 0 0
Germany
State/province [43] 0 0
Thueringen
Country [44] 0 0
Greece
State/province [44] 0 0
Alexandroupolis
Country [45] 0 0
Greece
State/province [45] 0 0
Athens
Country [46] 0 0
Greece
State/province [46] 0 0
Thessaloniki
Country [47] 0 0
Israel
State/province [47] 0 0
Jerusalem
Country [48] 0 0
Israel
State/province [48] 0 0
Kfar Saba
Country [49] 0 0
Israel
State/province [49] 0 0
Tel Aviv
Country [50] 0 0
Israel
State/province [50] 0 0
Tel Hashomer
Country [51] 0 0
Italy
State/province [51] 0 0
Emilia-Romagna
Country [52] 0 0
Italy
State/province [52] 0 0
Lazio
Country [53] 0 0
Italy
State/province [53] 0 0
Lombardia
Country [54] 0 0
Italy
State/province [54] 0 0
Piemonte
Country [55] 0 0
Italy
State/province [55] 0 0
Sicilia
Country [56] 0 0
Italy
State/province [56] 0 0
Toscana
Country [57] 0 0
Japan
State/province [57] 0 0
Aichi
Country [58] 0 0
Japan
State/province [58] 0 0
Aomori
Country [59] 0 0
Japan
State/province [59] 0 0
Chiba
Country [60] 0 0
Japan
State/province [60] 0 0
Ehime
Country [61] 0 0
Japan
State/province [61] 0 0
Fukuoka
Country [62] 0 0
Japan
State/province [62] 0 0
Fukushima
Country [63] 0 0
Japan
State/province [63] 0 0
Gifu
Country [64] 0 0
Japan
State/province [64] 0 0
Gunma
Country [65] 0 0
Japan
State/province [65] 0 0
Hokkaido
Country [66] 0 0
Japan
State/province [66] 0 0
Hyogo
Country [67] 0 0
Japan
State/province [67] 0 0
Kanagawa
Country [68] 0 0
Japan
State/province [68] 0 0
Kochi
Country [69] 0 0
Japan
State/province [69] 0 0
Kyoto
Country [70] 0 0
Japan
State/province [70] 0 0
Nagano
Country [71] 0 0
Japan
State/province [71] 0 0
Okayama
Country [72] 0 0
Japan
State/province [72] 0 0
Osaka
Country [73] 0 0
Japan
State/province [73] 0 0
Shizuoka
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Busan
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Seongnam-si, Gyeonggi-do
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Seoul
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Ulsan
Country [78] 0 0
Netherlands
State/province [78] 0 0
Dordrecht
Country [79] 0 0
Netherlands
State/province [79] 0 0
Groningen
Country [80] 0 0
New Zealand
State/province [80] 0 0
Christchurch
Country [81] 0 0
New Zealand
State/province [81] 0 0
Dunedin
Country [82] 0 0
New Zealand
State/province [82] 0 0
Newtown
Country [83] 0 0
New Zealand
State/province [83] 0 0
Takapuna, Auckland
Country [84] 0 0
Poland
State/province [84] 0 0
Chorzow
Country [85] 0 0
Poland
State/province [85] 0 0
Krakow
Country [86] 0 0
Poland
State/province [86] 0 0
Lodz
Country [87] 0 0
Poland
State/province [87] 0 0
Lublin
Country [88] 0 0
Poland
State/province [88] 0 0
Nowy Sacz
Country [89] 0 0
Poland
State/province [89] 0 0
Poznan
Country [90] 0 0
Poland
State/province [90] 0 0
Warszawa
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Moscow
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Nizhniy Novgorod
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Novosibirsk
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Samara
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Saratov
Country [96] 0 0
Russian Federation
State/province [96] 0 0
St'Petersburg
Country [97] 0 0
Russian Federation
State/province [97] 0 0
St. Petersburg
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Ufa
Country [99] 0 0
Spain
State/province [99] 0 0
Badalona
Country [100] 0 0
Spain
State/province [100] 0 0
Barcelona
Country [101] 0 0
Spain
State/province [101] 0 0
Cáceres
Country [102] 0 0
Spain
State/province [102] 0 0
Gijón
Country [103] 0 0
Spain
State/province [103] 0 0
Madrid
Country [104] 0 0
Spain
State/province [104] 0 0
Murcia
Country [105] 0 0
Spain
State/province [105] 0 0
Móstoles
Country [106] 0 0
Spain
State/province [106] 0 0
Pamplona
Country [107] 0 0
Spain
State/province [107] 0 0
Pozuelo De Alarcón/Madrid
Country [108] 0 0
Spain
State/province [108] 0 0
Salamanca
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Staffordshire
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Surrey
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Bournemouth
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Cardiff
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Dundee
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Leicester
Country [115] 0 0
United Kingdom
State/province [115] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


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