Comparison of belantamab mafodotin, bortezomib and dexamethasone versus daratumumab, bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma

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What is this study about?

This study focuses on treating patients with Multiple Myeloma that has returned or not responded to previous treatment. The research compares two different treatment combinations. The first combination includes belantamab mafodotin, bortezomib, and dexamethasone. The second combination uses daratumumab instead of belantamab mafodotin, along with bortezomib and dexamethasone.

The medications will be given in different ways – some as tablets taken by mouth, while others will be given through an intravenous line (directly into a vein). Dexamethasone comes as tablets and can also be given through an intravenous line. Bortezomib and daratumumab are given through an intravenous line, while belantamab mafodotin is given as a powder that is mixed into a solution for intravenous use.

The main purpose of this study is to determine if the treatment combination with belantamab mafodotin works better than the combination with daratumumab in preventing the cancer from getting worse. The study will measure how long participants live without their disease getting worse, along with tracking side effects and other health outcomes.

1 Initial treatment assignment

You will be randomly assigned to one of two treatment groups:

Group 1: Belantamab mafodotin with bortezomib and dexamethasone

Group 2: Daratumumab with bortezomib and dexamethasone

2 Treatment administration

Medications will be given in the following ways:

Belantamab mafodotin and daratumumab: through an intravenous (IV) infusion into your vein

Bortezomib: through an IV injection

Dexamethasone: as tablets taken by mouth or through IV injection

3 Health monitoring

Regular check-ups will monitor your health status

Blood tests will be performed to check your body’s response to treatment

Eye examinations will be conducted regularly

Your doctor will assess if your disease is stable, improving, or progressing

4 Response evaluation

Your response to treatment will be measured through:

Regular blood and urine tests to check protein levels

Assessment of any changes in your symptoms

Evaluation of your overall health and quality of life

5 Follow-up period

After completing treatment, you will continue to be monitored

Regular check-ups will track your long-term health status

The study will continue until June 2026

Who Can Join the Study?

  • Must be at least 18 years old at the time of giving consent
  • Must have a confirmed diagnosis of multiple myeloma and have received at least one previous treatment that was not successful
  • Must be able to understand and sign an informed consent form
  • Must have an ECOG performance status of 0 to 2 (a measure of daily living abilities, where 0 means fully active and 2 means able to do light activities)
  • For female participants:
    • Must not be pregnant or breastfeeding
    • Must use highly effective contraception during treatment and for 4 months after
    • Must have a negative pregnancy test before starting treatment
  • For male participants:
    • Must use contraception during treatment and for 6 months after
    • Must agree not to donate sperm during this period
  • If previously had stem cell transplant, it must have been completed more than 100 days before starting the study and have no current infections
  • Must have measurable disease through at least one of these tests:
    • Protein levels in urine of 200 mg or more in 24 hours
    • Protein levels in blood of 0.5 g/dL or more
    • Abnormal light chain protein levels in blood
  • Must have adequate organ function as shown by blood tests
  • Any side effects from previous treatments must be resolved or mild before starting the study

Who Cannot Join the Study?

  • Active plasma cell leukemia (a type of blood cancer where abnormal plasma cells are found in the blood)
  • Known active central nervous system myeloma (cancer spread to brain or spinal cord)
  • Stem cell transplant within 12 weeks before starting the study treatment
  • Prior treatment with belantamab mafodotin (study medication)
  • Severe corneal conditions (eye surface problems) that could affect vision
  • Major surgery within 4 weeks before starting study treatment
  • Active hepatitis B or C infection (liver infections)
  • HIV infection or AIDS
  • Any other type of active cancer requiring treatment
  • Severe heart conditions including heart failure or unstable heart disease
  • Severe kidney problems requiring dialysis
  • History of serious allergic reactions to similar treatments
  • Pregnancy or breastfeeding
  • Unable to swallow oral medications
  • Any condition that could interfere with study participation according to the doctor’s assessment

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy

Other Sites

Site Name City Country Status
Hopitaux Universitaires Pitie Salpetriere Paris France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich Chorzow Poland
Alexandra Hospital Athens Greece
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Centre Hospitalier Universitaire De Rennes Rennes France
Hospital General Universitario Gregorio Maranon Madrid Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Hospital San Pedro De Alcantara Caceres Spain
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Hospital Universitario Rey Juan Carlos Mostoles Spain
Vrije Universiteit Brussel Jette Belgium
Universita Degli Studi Di Brescia Brescia Italy
Pratia S.A. Skorzewo Poland
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Universitaire De Caen Normandie Caen France
University Hospital Ostrava Ostrava Czechia
Cyjejuhls Ucntzythjsvzmr Snlbehncf Woluwe-Saint-Lambert Belgium
Kyajjbkc dnq Uqjgvnpmrgav Mquuxptu Ayq Munich Germany
Urscitcrnoze Mvcpgsr Crqphoa Giizeyzjn Groningen The Netherlands
Izjxzytg Cmzdwj Dolwlyxqqgpizbtjn L'hospitalet De Llobregat Spain
Wkphwejpqak Wqquvbbpihbgudfampvy Csvbbjk Okewmctcu I Toljvrjqlzpfm Ic Mkimkizizeo W Lwyso Lodz Poland
Tzclfdqkwx Cavppq Hrysekyq Thessaloniki Greece
Seelduz Sfydjekuhpdinzc Ibk Jvgkwnfc Ssafvvkzgtpp W Nnfzg Sqyoa Nowy Sacz Poland
Abeulmx Uhoqz Sicfljmff Luzrag Dv Bhioloy Bologna Italy
Uemyqhtrce Hctgzarc Cqeonqn Cologne Germany
Neewhxox Intpiafl Ouyzofyru Ibr Mpuip Sohcvbpoybcmnippcnuidaaoeocm Iabnvepj Bdzbqczy Cracow Poland
Uzqmlzawerycjawxhvzsf Wwhfigoie Auo Wuerzburg Germany
Urhjvvbiuocukqauemtqr Dhqyfkbhrmi Aat Duesseldorf Germany
Hatkluwp Vemp dvmycfjn Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
28.05.2020
Czechia Czechia
Recruiting
28.05.2020
France France
Recruiting
28.05.2020
Germany Germany
Not yet recruiting
28.05.2020
Greece Greece
Not recruiting
28.05.2020
Italy Italy
Not recruiting
28.05.2020
Poland Poland
Not recruiting
28.05.2020
Spain Spain
Not recruiting
28.05.2020
The Netherlands The Netherlands
Not recruiting
28.05.2020

Trial locations

Belantamab mafodotin is a targeted antibody therapy used to treat multiple myeloma, a type of blood cancer. It works by attaching to a specific protein on cancer cells and delivering a medication that helps destroy them.

Bortezomib is a cancer medication that belongs to a class of drugs called proteasome inhibitors. It works by blocking certain proteins that cancer cells need to grow and survive, helping to slow or stop the spread of cancer cells.

Dexamethasone is a corticosteroid medication that helps reduce inflammation and suppress the immune system. In cancer treatment, it’s often used alongside other medications to help make them more effective and manage certain side effects.

Daratumumab is a monoclonal antibody therapy that targets a specific protein found on multiple myeloma cells. It works by helping the immune system recognize and destroy cancer cells.

Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that normally produce antibodies to help fight infections. In this condition, abnormal plasma cells multiply uncontrollably in the bone marrow, forming tumors in multiple bones throughout the body. These cancerous cells produce large amounts of abnormal proteins while preventing the production of normal, healthy blood cells. The disease can weaken bones, decrease normal blood cell production, and cause problems with kidney function. Multiple myeloma often develops slowly and may not cause symptoms in its early stages.

Trial ID:
2023-510537-28-00
Protocol code:
207503
NCT ID:
NCT04246047
Trial Phase:
Therapeutic confirmatory (Phase III)

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