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Efficacy and Safety Evaluation of Belantamab Mafodotin Versus Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients

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What is this study about?

This clinical trial is focused on studying a condition called Relapsed/Refractory Multiple Myeloma, which is a type of blood cancer that has returned or is not responding to treatment. The study is comparing two different treatments to see which is more effective. One treatment involves a medication called Belantamab Mafodotin, and the other is a combination of two drugs: Pomalidomide and Dexamethasone. The purpose of the study is to evaluate the effectiveness and safety of these treatments in patients with this type of multiple myeloma.

Participants in the study will be randomly assigned to receive either Belantamab Mafodotin or the combination of Pomalidomide and Dexamethasone. The study will monitor the participants over a period to see how well the treatments work in controlling the disease and to observe any side effects. The study will also look at how long the treatments can keep the disease from getting worse and how they affect the overall health and quality of life of the participants.

The trial will involve regular check-ups and tests to track the progress of the disease and the effects of the treatments. Participants will receive either the study medication or a placebo, which is a substance with no active drug, to compare the results. The study aims to provide valuable information that could help improve treatment options for people with relapsed or refractory multiple myeloma in the future.

Who Can Join the Study?

  • You must be able to provide signed informed consent, which means you agree to participate in the study after being fully informed of all its details, rules, and risks.
  • You must be at least 18 years old at the time of signing the consent form.
  • You must have an ECOG performance status of 0 to 2, which is a scale used by doctors to measure how well you can perform daily activities and your general level of physical functioning.
  • You must have a confirmed diagnosis of multiple myeloma, which is a type of cancer that affects the plasma cells in your blood.
  • You must have either had an autologous stem cell transplant (a procedure where your own healthy blood-forming cells are put back into your body) or be considered ineligible for one.
  • You must have received at least two prior lines of treatment for multiple myeloma, including at least two cycles of both lenalidomide and a proteasome inhibitor (medicines used to treat cancer).
  • Your cancer must be showing signs of progression (getting worse) or you must not be responding to your current treatment.
  • Your cancer must be measurable through specific blood or urine tests that check for certain proteins or free light chains (abnormal proteins produced by cancer cells).
  • If you have previously had a stem cell transplant, it must have occurred more than 100 days before starting this study, and you must not have any active infections.
  • Your organ systems (such as your heart, lungs, liver, and kidneys) must be functioning well.
  • You must agree to use effective contraception (methods to prevent pregnancy) during the study and for a specific period after the study ends to prevent harm to a potential fetus.
  • For female participants, you must not be pregnant or breastfeeding, and you must provide negative pregnancy tests before starting treatment.
  • For male participants, you must agree to use protection or follow specific rules regarding sperm donation and sexual activity to prevent pregnancy.
  • Any toxicities (side effects or damage) from previous treatments must be mild, specifically Grade 1 or less, with the exception of alopecia (hair loss) and peripheral neuropathy (nerve damage that causes tingling or numbness in the hands or feet), which can be Grade 2.

Who Cannot Join the Study?

  • People with symptomatic amyloidosis, which is a condition where abnormal proteins build up in organs, or active POEMS syndrome, a rare disorder involving nerve, organ, and skin issues.
  • People with active plasma cell leukemia, a type of blood cancer, at the time of screening.
  • Anyone with a history of pneumonitis (inflammation of the lung tissue) that required steroids (strong anti-inflammatory medicines), or anyone currently having pneumonitis.
  • Evidence of active mucosal or internal bleeding, meaning bleeding in the mouth, throat, or inside the body.
  • People with unstable liver or biliary disease (problems with the liver or gallbladder), such as ascites (fluid buildup in the abdomen), encephalopathy (brain dysfunction caused by liver issues), coagulopathy (blood clotting problems), hypoalbuminemia (low levels of a specific protein in the blood), oesophageal or gastric varices (swollen veins in the food pipe or stomach), jaundice (yellowing of the skin or eyes), or cirrhosis (scarring of the liver).
  • People who have or currently have other types of malignancies (cancers) other than multiple myeloma, unless that cancer has been medically stable (not changing or growing) for at least 2 years and is not being actively treated.
  • People with cardiovascular risk, which includes: uncontrolled arrhythmias (irregular heartbeats), specific electrocardiogram (ECG) abnormalities (irregular patterns in the heart’s electrical activity), a history of myocardial infarction (heart attack), acute coronary syndromes (sudden loss of blood flow to the heart), coronary angioplasty or stenting (procedures to open blocked heart arteries), or heart failure (the heart cannot pump enough blood).
  • People with uncontrolled hypertension (high blood pressure).
  • Anyone with a known hypersensitivity reaction (an allergic reaction) to the study drugs or their components.
  • Pregnant or lactating (breastfeeding) women.
  • People with an active infection that requires medical treatment.
  • People with human immunodeficiency virus (HIV), unless they meet very specific requirements regarding their anti-retroviral therapy (medicine to treat HIV), viral load (amount of virus in the blood), and CD4+ T-cell counts (a type of immune cell).
  • People with Hepatitis B, unless they meet specific medical requirements.
  • People who have used other anti-myeloma therapy (treatments for myeloma) or experimental drugs within 14 days before the study begins.
  • People who test positive for hepatitis C, unless they meet specific medical requirements.
  • People who cannot tolerate thromboembolic prophylaxis (medicine or methods used to prevent blood clots).
  • People with current corneal epithelial disease (problems with the clear front surface of the eye), except for very mild cases.
  • People who have received anti-MM monoclonal antibody treatment within 30 days before the study begins.
  • People who have had BCMA-targeted therapy or pomalidomide treatment before.
  • People who have undergone plasmapheresis (a process that filters the blood) within 7 days before the study starts.
  • People who have had an allogeneic stem cell transplant (receiving stem cells from a different person).
  • Anyone who has had major surgery within the last 4 weeks.
  • People with an active renal condition (kidney problems), such as a kidney infection or the need for dialysis (a machine that cleans the blood).
  • People with any serious or unstable medical or psychiatric disorder (mental health condition) that could make participating in the study unsafe.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Evangelismos S.A. Athens Greece
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Meander Medical Center Amersfoort The Netherlands
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Vrije Universiteit Brussel Jette Belgium
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
University Of Debrecen Debrecen Hungary
Semmelweis University Budapest Hungary
Pratia S.A. Skorzewo Poland
Utbqlkeswfhyuz Cmrteyo Kgvyybgej Gdansk Poland
Mdwyhdteq Ihocblvzot Cgkiveta Shuwmflu Sgn z olsj Warsaw Poland
Tajmmijqid Cfymzx Hmizpzkf Thessaloniki Greece
Adtzkls Usigy Sxyjokpaq Loelbk Dt Benqhyw Bologna Italy
Ukntfwlwhp Oq Akqkmua Edegem Belgium
Upsgpkemyz Dbmfj Smvvc Dz Rsmj Ln Srwduben Rome Italy
Hckhxebk Uaraiqbxprmct Hfchtpbl Tihib y Phmynp Icouuoit Carjru dkwmythmvyivbojvd (hzmp Badalona 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
02.04.2020
Bulgaria Bulgaria
Not recruiting
02.04.2020
France France
Not recruiting
02.04.2020
Germany Germany
Not recruiting
02.04.2020
Greece Greece
Not recruiting
02.04.2020
Hungary Hungary
Not recruiting
02.04.2020
Italy Italy
Not recruiting
02.04.2020
Poland Poland
Not recruiting
02.04.2020
Spain Spain
Not recruiting
02.04.2020
The Netherlands The Netherlands
Not recruiting
02.04.2020

Trial locations

Investigated drugs:

Belantamab mafodotin is an experimental therapy given through an injection into a vein. It is designed to target and attack specific cells involved in multiple myeloma.

Pomalidomide is a medication taken by mouth in capsule form that helps to treat certain types of blood cancers.

Dexamethasone is a type of steroid medication taken by mouth in tablet form that is used to help reduce inflammation and assist in the treatment of multiple myeloma.

Relapsed/Refractory Multiple Myeloma – This is a type of cancer that affects plasma cells, which are a type of white blood cell. The condition is considered relapsed when the cancer returns after a period of improvement or disappearance. It is classified as refractory when the cancer does not respond to treatments or continues to grow despite them. Over time, the abnormal plasma cells accumulate in the bone marrow. This accumulation can lead to various changes in the body’s functions.

Trial ID:
2023-508962-14-00
Protocol code:
207495
NCT ID:
NCT04162210
Trial Phase:
Therapeutic confirmatory (Phase III)

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