Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

— DREAMM 7  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04246047
• Other study ID #: 207503
• Secondary ID: 2018-003993-29
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 7, 2020
• Est. completion date: June 19, 2026

Study information

• Verified date: December 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 571
• Est. completion date: June 19, 2026
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Belantamab mafodotin
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate
• Daratumumab
Anti-cluster of differentiation 38 [CD-38] monoclonal antibody
• Bortezomib
Proteasome Inhibitor
• Dexamethasone
Synthetic glucocorticoid with anti-tumor activity

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Benowa	Queensland
Australia	GSK Investigational Site	Box Hill	Victoria
Australia	GSK Investigational Site	Camperdown	New South Wales
Australia	GSK Investigational Site	Heidelberg	Victoria
Australia	GSK Investigational Site	Herston	Queensland
Australia	GSK Investigational Site	Kurralta Park	South Australia
Australia	GSK Investigational Site	Liverpool	New South Wales
Australia	GSK Investigational Site	Melbourne	Victoria
Australia	GSK Investigational Site	Murdoch	Western Australia
Australia	GSK Investigational Site	Nedlands	Western Australia
Australia	GSK Investigational Site	St Leonards	New South Wales
Australia	GSK Investigational Site	Waratah	New South Wales
Australia	GSK Investigational Site	Wollongong	New South Wales
Belgium	GSK Investigational Site	Brussel
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Roeselare
Brazil	GSK Investigational Site	Florianopolis	Santa Catarina
Brazil	GSK Investigational Site	Joinville	Santa Catarina
Brazil	GSK Investigational Site	Natal	Rio Grande Do Norte
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Rio de Janeiro
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	São Paulo
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Montréal	Quebec
Canada	GSK Investigational Site	Québec	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Changchun	Jilin
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	GuangZhou
China	GSK Investigational Site	Hangzhou	Zhejiang
China	GSK Investigational Site	Jianan	Shandong
China	GSK Investigational Site	Jiang Su Province
China	GSK Investigational Site	Nanjing	Jiangsu
China	GSK Investigational Site	Shenyang
China	GSK Investigational Site	Tianjin
China	GSK Investigational Site	Tianjin
China	GSK Investigational Site	Wuhan
China	GSK Investigational Site	Zhengzhou
Czechia	GSK Investigational Site	Brno
Czechia	GSK Investigational Site	Hradec Kralove
Czechia	GSK Investigational Site	Ostrava
Czechia	GSK Investigational Site	Praha 2
France	GSK Investigational Site	Amiens cedex 1
France	GSK Investigational Site	Caen cedex 9
France	GSK Investigational Site	Nice
France	GSK Investigational Site	Paris cedex 13
France	GSK Investigational Site	Rennes cedex 9
Germany	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Jena	Thueringen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Ulm	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wuerzburg	Bayern
Greece	GSK Investigational Site	Alexandroupolis
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Thessaloniki
Israel	GSK Investigational Site	Jerusalem
Israel	GSK Investigational Site	Kfar Saba
Israel	GSK Investigational Site	Tel Aviv
Israel	GSK Investigational Site	Tel Hashomer
Italy	GSK Investigational Site	Bergamo	Lombardia
Italy	GSK Investigational Site	Bologna	Emilia-Romagna
Italy	GSK Investigational Site	Brescia	Lombardia
Italy	GSK Investigational Site	Catania	Sicilia
Italy	GSK Investigational Site	Meldola	Emilia-Romagna
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Ravenna	Emilia-Romagna
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Siena	Toscana
Italy	GSK Investigational Site	Torino	Piemonte
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Aomori
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Ehime
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukushima
Japan	GSK Investigational Site	Gifu
Japan	GSK Investigational Site	Gunma
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kochi
Japan	GSK Investigational Site	Kyoto
Japan	GSK Investigational Site	Nagano
Japan	GSK Investigational Site	Okayama
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Shizuoka
Korea, Republic of	GSK Investigational Site	Busan
Korea, Republic of	GSK Investigational Site	Seongnam-si, Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Ulsan
Netherlands	GSK Investigational Site	Dordrecht
Netherlands	GSK Investigational Site	Groningen
New Zealand	GSK Investigational Site	Christchurch
New Zealand	GSK Investigational Site	Dunedin
New Zealand	GSK Investigational Site	Newtown
New Zealand	GSK Investigational Site	Takapuna, Auckland
Poland	GSK Investigational Site	Chorzow
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Nowy Sacz
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Warszawa
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Nizhniy Novgorod
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	Saratov
Russian Federation	GSK Investigational Site	St'Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	Ufa
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Cáceres
Spain	GSK Investigational Site	Gijón
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Móstoles
Spain	GSK Investigational Site	Murcia
Spain	GSK Investigational Site	Pamplona
Spain	GSK Investigational Site	Pozuelo De Alarcón/Madrid
Spain	GSK Investigational Site	Salamanca
United Kingdom	GSK Investigational Site	Bournemouth
United Kingdom	GSK Investigational Site	Cardiff
United Kingdom	GSK Investigational Site	Dundee
United Kingdom	GSK Investigational Site	Leicester
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Stoke-on-Trent	Staffordshire
United Kingdom	GSK Investigational Site	Sutton	Surrey
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Roanoke	Virginia
United States	GSK Investigational Site	Tyler	Texas
United States	GSK Investigational Site	Westwood	Kansas
United States	GSK Investigational Site	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  China,  Czechia,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	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	Up to an average of 37 months
Secondary	Complete response rate (CRR)	Percentage of participants with a confirmed complete response or better.	Up to 74 months
Secondary	Overall response rate (ORR)	Percentage of participants with a confirmed partial response or better.	Up to 74 months
Secondary	Clinical Benefit Rate (CBR)	Percentage of participants with a confirmed partial response or better	Up to 74 months
Secondary	Duration of response (DoR)	Time from first documented evidence of partial response or better to date of first documented progression or death, whichever occurs first.	Up to 74 months
Secondary	Time to response (TTR)	Time from the date of randomization and the first documented evidence of response among participants who achieve partial response or better.	Up to 74 months
Secondary	Time to Progression (TTP)	Time from the date of randomization until the first documented date of disease progression or death, whichever occurs first.	Up to 74 months
Secondary	Overall survival (OS)	Time from the date of randomization until the date of death due to any cause.	Up to 74 months
Secondary	Progression-free survival on subsequent line of therapy (PFS2)	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 .	Up to 74 months
Secondary	Minimal Residual Disease (MRD) negativity rate	Minimal Residual Disease (MRD) negativity rate, defined as the percentage of participants who are MRD negative by next generation sequencing (NGS)	Up to 74 months
Secondary	Number of participants with adverse events (AEs)	AEs will be collected, including abnormal laboratory parameters.	Up to 74 months
Secondary	Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters		Up to 74 months
Secondary	Number of participants with abnormal ocular findings on ophthalmic examination	Ophthalmic examination will assess abnormal findings.	Up to 74 months
Secondary	Plasma concentrations of belantamab mafodotin at indicated time points	Plasma concentrations of belantamab mafodotin in Arm A.	Up to 74 months
Secondary	Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points	Plasma concentrations of cys-mcMMAF in Arm A.	Up to 74 months
Secondary	Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin	Plasma concentrations of belantamab mafodotin ADAs in Arm A.	Up to 74 months
Secondary	Titers of ADAs against belantamab mafodotin	Titers of ADAs in Arm A.	Up to 74 months
Secondary	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)	PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score..	Up to 74 months
Secondary	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.	Baseline and Up to 74 months
Secondary	Change from Baseline in HRQoL as measured by EORTC IL52, 20-Item Multiple Myeloma Module (QLQ-MY20)	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.	Baseline and Up to 74 months