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
- Diseases
- Multiple myeloma
- 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
Sites (72)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Benowa | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Wollongong | Australia | Unknown status |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Active, not recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| - Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Active, not recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Active, not recruiting |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Active, not recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Active, not recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Active, not recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital San Pedro De Alcántara Coordinator of this site? Confirm its status | Cáceres | Spain | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Rey Juan Carlos Coordinator of this site? Confirm its status | Móstoles | Spain | Active, not recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Recruiting |
| Hopital Universitaire Pitie Salpetriere Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Theageneio Cancer Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Active, not recruiting |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Aichi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Aomori | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Ehime | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Gifu | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Gunma | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Hyōgo | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Kochi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Nagano | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Pusan | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Albert Schweitzer Ziekenhuis Coordinator of this site? Confirm its status | Dordrecht | Netherlands | Active, not recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Active, not recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich Coordinator of this site? Confirm its status | Chorzów | Poland | Active, not recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu SPZOZ Coordinator of this site? Confirm its status | Nowy Sacz | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Saratov | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Ufa | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Fairfield | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Yuma | United States | Unknown status |
Related publications
- Threshold Price of Belantamab for Relapsed/Refractory Multiple Myeloma in China: A Cost-Effectiveness Analysis.Pharmacoecon Open · 2026 · PMID 42726457
This page is information, not medical advice. Discuss any trial with your doctor.