Clinical trial NCT04246047: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Global Cohort
Belantamab mafodotin
Relapsed/refractory multiple myeloma
Daratumumab
Bortezomib
Dexamethasone
Multiple Myeloma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2020-01-29
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 41 months
Secondary outcomes:
measure: Complete Response Rate (CRR)
timeFrame: Up to 73 months
measure: Overall Response Rate (ORR)
timeFrame: Up to 73 months
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to 73 months
measure: Duration of Response (DoR)
timeFrame: Up to 73 months
measure: Time to Response (TTR)
timeFrame: Up to 73 months
measure: Time to Progression (TTP)
timeFrame: Up to 73 months
measure: Overall Survival (OS)
timeFrame: Up to 73 months
measure: Progression-free Survival on Subsequent Line of Therapy (PFS2)
timeFrame: Up to 73 months
measure: Minimal Residual Disease (MRD) Negativity Rate
timeFrame: Up to 73 months
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 73 months
measure: Number of Participants With Clinically Significant Changes in Hematology Parameters
timeFrame: Up to 73 months
measure: Number of Participants With Clinically Significant Changes in Clinical Chemistry
timeFrame: Up to 73 months
measure: Number of Participants With Clinically Significant Changes in Urine Dipstick
timeFrame: Up to 73 months
measure: Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination
timeFrame: Up to 73 months
measure: Plasma Concentrations of Belantamab Mafodotin (Total Antibody) at Indicated Time Points
timeFrame: Up to 73 months
measure: Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points
timeFrame: Up to 73 months
measure: Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) at Indicated Time Points
timeFrame: Up to 73 months
measure: Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
timeFrame: Up to 73 months
measure: Titers of ADAs Against Belantamab Mafodotin
timeFrame: Up to 73 months
measure: 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)
timeFrame: Up to 73 months
measure: 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)
timeFrame: Up to 73 months
measure: Change From Baseline in HRQoL as Measured by EORTC IL52
timeFrame: Up to 73 months
Other outcomes:
Locations:
city: Yuma
country: United States
facility: GSK Investigational Site
state: Arizona
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Fairfield
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: Tyler
country: United States
facility: GSK Investigational Site
state: Texas
city: Roanoke
country: United States
facility: GSK Investigational Site
state: Virginia
city: Camperdown
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Liverpool
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Waratah
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Wollongong
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Benowa
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Herston
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Ashford
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Heidelberg
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Murdoch
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Brussel
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Roeselare
country: Belgium
facility: GSK Investigational Site
city: Florianopolis
country: Brazil
facility: GSK Investigational Site
city: Joinville
country: Brazil
facility: GSK Investigational Site
city: Natal
country: Brazil
facility: GSK Investigational Site
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
city: Rio de Janeiro
country: Brazil
facility: GSK Investigational Site
city: SAo Paulo
country: Brazil
facility: GSK Investigational Site
city: SAo Paulo
country: Brazil
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city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: Montreal
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facility: GSK Investigational Site
state: Quebec
city: Quebec City
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Changchun
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: GuangZhou
country: China
facility: GSK Investigational Site
city: Hangzhou
country: China
facility: GSK Investigational Site
city: Jinan
country: China
facility: GSK Investigational Site
city: Nanjing
country: China
facility: GSK Investigational Site
city: Shenyang
country: China
facility: GSK Investigational Site
city: Suzhou
country: China
facility: GSK Investigational Site
city: Tianjin
country: China
facility: GSK Investigational Site
city: Zhengzhou
country: China
facility: GSK Investigational Site
city: Brno
country: Czechia
facility: GSK Investigational Site
city: Hradec Kralove
country: Czechia
facility: GSK Investigational Site
city: Ostrava
country: Czechia
facility: GSK Investigational Site
city: Praha 2
country: Czechia
facility: GSK Investigational Site
city: Amiens cedex 1
country: France
facility: GSK Investigational Site
city: Caen cedex 9
country: France
facility: GSK Investigational Site
city: Nice cedex 3
country: France
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city: Paris
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facility: GSK Investigational Site
city: Rennes
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country: Germany
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city: Muenchen
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facility: GSK Investigational Site
city: Ulm
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city: Wuerzburg
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city: Alexandroupolis
country: Greece
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city: Athens
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
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city: Jerusalem
country: Israel
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city: Kfar Saba
country: Israel
facility: GSK Investigational Site
city: Tel Aviv
country: Israel
facility: GSK Investigational Site
city: Tel Hashomer
country: Israel
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city: Bergamo
country: Italy
facility: GSK Investigational Site
city: Bologna
country: Italy
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country: Italy
facility: GSK Investigational Site
city: Catania
country: Italy
facility: GSK Investigational Site
city: Meldola FC
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Ravenna
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Siena
country: Italy
facility: GSK Investigational Site
city: Torino
country: Italy
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aomori
country: Japan
facility: GSK Investigational Site
city: Ehime
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Gifu
country: Japan
facility: GSK Investigational Site
city: Gunma
country: Japan
facility: GSK Investigational Site
city: Hyogo
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kochi
country: Japan
facility: GSK Investigational Site
city: Nagano
country: Japan
facility: GSK Investigational Site
city: Okayama
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Shizuoka
country: Japan
facility: GSK Investigational Site
city: Pusan
country: Korea, Republic of
facility: GSK Investigational Site
city: Seongnam-si Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Ulsan
country: Korea, Republic of
facility: GSK Investigational Site
city: Dordrecht
country: Netherlands
facility: GSK Investigational Site
city: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Dunedin
country: New Zealand
facility: GSK Investigational Site
city: Takapuna Auckland
country: New Zealand
facility: GSK Investigational Site
city: Wellington
country: New Zealand
facility: GSK Investigational Site
city: Chorzow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Nowy Sacz
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: N Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Samara
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: St Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Ufa
country: Russian Federation
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Caceres
country: Spain
facility: GSK Investigational Site
city: Gijon
country: Spain
facility: GSK Investigational Site
city: L'Hospitalet De Llobrega
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: MOstoles Madrid
country: Spain
facility: GSK Investigational Site
city: Murcia
country: Spain
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city: PamplonaNavarra
country: Spain
facility: GSK Investigational Site
city: Pozuelo De AlarcOn Madr
country: Spain
facility: GSK Investigational Site
city: Salamanca
country: Spain
facility: GSK Investigational Site
city: Bournemouth
country: United Kingdom
facility: GSK Investigational Site
city: Cardiff
country: United Kingdom
facility: GSK Investigational Site
city: Dundee
country: United Kingdom
facility: GSK Investigational Site
city: Leicester
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Stoke on Trent
country: United Kingdom
facility: GSK Investigational Site
city: Sutton
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: