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NCT04246047Active, not recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 23 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
494 (actual)
First submitted
27 Jan 2020
Start date
7 May 2020
Primary completion date
2 Oct 2023
Lead sponsor
GlaxoSmithKline
NCT number
NCT04246047
EU CT number
2023-510537-28-00
EudraCT number
2018-003993-29

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 494
  • From 7 May 2020 to the primary completion date, 2 Oct 2023
  • 72 sites in 16 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy.
  • Prior allogenic stem cell transplant.

Other illness

  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies.
  • Corneal epithelial disease.

Other

  • Intolerant to daratumumab.
  • Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.

Who the study is looking for

  • 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;
    • Urine M-protein excretion \>=200 mg per 24-hour, or
    • Serum M-protein concentration \>=0.5 grams per deciliter (g/dL), or
    • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (72)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BenowaAustraliaUnknown status
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LiverpoolAustraliaUnknown status
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WollongongAustraliaUnknown status
UZ Brussel
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JetteBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
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BeijingChinaUnknown status
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JinanChinaUnknown status
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ShenyangChinaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaRecruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaRecruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaRecruiting
University Hospital Cologne AöR
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CologneGermanyActive, not recruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyActive, not recruiting
Universitaetsklinikum Jena KöR
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JenaGermanyActive, not recruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyActive, not recruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyActive, not recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyActive, not recruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital San Pedro De Alcántara
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CáceresSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario Rey Juan Carlos
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MóstolesSpainActive, not recruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainActive, not recruiting
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceRecruiting
Hopital Universitaire Pitie Salpetriere
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Paris Cedex 13FranceRecruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceRecruiting
Alexandra Hospital
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AthensGreeceActive, not recruiting
Theageneio Cancer Hospital
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ThessalonikiGreeceActive, not recruiting
-
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Tel AvivIsraelUnknown status
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyActive, not recruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
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AichiJapanUnknown status
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AomoriJapanUnknown status
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EhimeJapanUnknown status
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FukuokaJapanUnknown status
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GifuJapanUnknown status
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GunmaJapanUnknown status
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HyōgoJapanUnknown status
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KanagawaJapanUnknown status
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KochiJapanUnknown status
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NaganoJapanUnknown status
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OkayamaJapanUnknown status
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OsakaJapanUnknown status
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ShizuokaJapanUnknown status
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PusanSouth KoreaUnknown status
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UlsanSouth KoreaUnknown status
Albert Schweitzer Ziekenhuis
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DordrechtNetherlandsActive, not recruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsActive, not recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
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ChorzówPolandActive, not recruiting
Pratia S.A.
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CracowPolandActive, not recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
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LublinPolandActive, not recruiting
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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LublinPolandActive, not recruiting
Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu SPZOZ
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Nowy SaczPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
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MoscowRussiaUnknown status
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Nizhny NovgorodRussiaUnknown status
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NovosibirskRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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SaratovRussiaUnknown status
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UfaRussiaUnknown status
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DenverUnited StatesUnknown status
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FairfieldUnited StatesUnknown status
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Kansas CityUnited StatesUnknown status
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TylerUnited StatesUnknown status
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YumaUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.