Study Comparing Belantamab Mafodotin with Pomalidomide and Dexamethasone to Bortezomib with Pomalidomide and Dexamethasone for Patients with Relapsed/Refractory Multiple Myeloma

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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 treatment combinations to see which is more effective. One combination includes Belantamab Mafodotin, Pomalidomide, and Dexamethasone, while the other includes Bortezomib, 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 receive one of the two treatment combinations. The study will monitor how the disease responds to the treatments and how long the response lasts. It will also look at the overall survival of participants, which means the length of time participants live after starting the treatment. The study will also assess any side effects that may occur and how the treatments affect the quality of life of the participants.

The study will take place over a period of time, with regular check-ups and assessments to track the progress of the disease and the effects of the treatment. Participants will be randomly assigned to one of the treatment groups, and some may receive a placebo as part of the study. The goal is to gather information that could help improve treatment options for people with relapsed or refractory multiple myeloma in the future.

1 joining the study

Upon joining the study, participants are randomly assigned to one of two treatment groups. The study aims to compare the effectiveness of two different treatment combinations for relapsed or refractory multiple myeloma.

2 treatment group assignment

Participants are assigned to either the B-Pd group or the PVd group. The B-Pd group receives a combination of belantamab mafodotin, pomalidomide, and dexamethasone. The PVd group receives bortezomib, pomalidomide, and dexamethasone.

3 medication administration

In the B-Pd group, belantamab mafodotin is administered intravenously. Pomalidomide is taken orally in capsule form, and dexamethasone is taken orally in tablet form.

In the PVd group, bortezomib is administered subcutaneously. Pomalidomide is taken orally in capsule form, and dexamethasone is taken orally in tablet form.

4 treatment schedule

The treatment is administered in cycles. Each cycle lasts 28 days. The specific dosage and frequency of each medication are determined by the study protocol and may vary based on individual response and tolerance.

5 monitoring and assessments

Participants undergo regular monitoring and assessments to evaluate the effectiveness of the treatment and to check for any side effects. This includes blood tests, imaging studies, and other necessary evaluations.

6 study duration

The study is expected to continue until February 2025. Participants will remain in the study until disease progression, unacceptable side effects, or withdrawal of consent.

Who Can Join the Study?

Must be able to give signed informed consent, which means you understand the study and agree to participate.
Both men and women must agree to follow the study’s rules about birth control.
Must be 18 years old or older.
Must have a confirmed diagnosis of multiple myeloma, a type of blood cancer, according to specific medical guidelines.
Must have an ECOG performance status of 0 to 2, which is a scale that measures how well you can perform daily activities. A score of 0 means fully active, while 2 means you are up and about more than half the day.
Must have been treated with at least one previous therapy for multiple myeloma, including a treatment with a drug called lenalidomide, and the disease must have gotten worse during or after the last treatment. You are eligible if you took lenalidomide at a dose of 10 mg or more daily for at least two cycles in a row.
Must have at least one measurable sign of the disease, such as:
- Urine M-protein excretion of 200 mg or more in 24 hours, or
- Serum M-protein concentration of 0.5 grams per deciliter or more, or
- Serum free light chain (FLC) level of 10 mg/dL or more, with an abnormal FLC ratio, if there is no measurable urine or serum M spike.
Must have had an autologous stem cell transplant (ASCT) or be considered not eligible for a transplant. If you had ASCT, it must have been more than 100 days before starting the study medication, and you must not have any active infections.
Any side effects from previous treatments must be mild (Grade 1 or less) at the time of joining the study, except for hair loss.
Must have adequate organ function as specified in the study protocol.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Relapsed/Refractory Multiple Myeloma cannot participate. This means the study is only for those with a specific type of blood cancer that has returned or is not responding to treatment.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have certain medical conditions that might interfere with the study or make it unsafe for them cannot participate.
Patients who are pregnant or breastfeeding cannot participate, as the study may involve risks to the baby.
Patients who are currently participating in another clinical trial cannot participate, as this could affect the results of the study.
Patients who have had a recent major surgery or are recovering from a major surgery cannot participate, as this could affect their health during the study.
Patients who have a history of certain heart problems or other serious health issues cannot participate, as these conditions could make the study unsafe for them.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital General Universitario Morales Meseguer	Murcia	Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
Hospital Universitario Rey Juan Carlos	Mostoles	Spain
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Evangelismos S.A.	Athens	Greece
University General Hospital Of Ioannina	Ioannina	Greece
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Alexandra Hospital	Athens	Greece
Hospital Clinic De Barcelona	Barcelona	Spain
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
251 Air Force General Hospital	Athens	Greece
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Servei De Salut De Les Illes Balears	Palma	Spain
Horhqcem Uritcfnwgeaem Dw Lr Pfaijdyq	Madrid	Spain
Irwfzemh Cbwqsr Dpnhmjmemczutcjqc	L'hospitalet De Llobregat	Spain
Waktifxsahn Wrydbxcspzzpsnwphczz Cdirbam Ozkdqgwma I Tsoaqvaofwtvn Iy Mnnuhxzxijb W Lmghj	Lodz	Poland
Cuje Dg Nimhp	Vandoeuvre Les Nancy	France
Aagovzv Unaos Sdafueliv Lpvppw Dj Bifastv	Bologna	Italy
Uhvnrvtoqyqbwk Clnnkhk Kcuutsmix	Gdansk	Poland
Uvfyjtstzp Dmvfl Saktc Dy Riuo Lr Sizcyuel	Rome	Italy
Hoywemkn Vuua decirvyu	Barcelona	Spain
Iekawwii Phclhwetgpgfxfr Creuan Cekcsx	Marseille	France

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.10.2020
France	Not recruiting	01.10.2020
Germany	Not recruiting	01.10.2020
Greece	Not recruiting	01.10.2020
Italy	Not recruiting	01.10.2020
Poland	Not recruiting	01.10.2020
Spain	Not recruiting	01.10.2020

Trial locations

Belantamab Mafodotin is a medication used in this trial to treat multiple myeloma, a type of blood cancer. It works by targeting and killing cancer cells, helping to control the disease.

Pomalidomide is a medication that helps the immune system fight cancer. It is used in combination with other drugs to treat multiple myeloma, especially when the disease has returned or is not responding to other treatments.

Dexamethasone is a steroid that reduces inflammation and helps control symptoms of multiple myeloma. It is often used in combination with other cancer treatments to enhance their effectiveness.

Bortezomib is a medication that interferes with the growth of cancer cells and slows their spread in the body. It is used to treat multiple myeloma and is often combined with other drugs to improve treatment outcomes.

Investigated diseases:

Plasma cell myeloma

Relapsed/Refractory Multiple Myeloma – This is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this condition, the cancer has returned after treatment (relapsed) or does not respond to treatment (refractory). It typically progresses by causing an overproduction of abnormal plasma cells, leading to bone damage, kidney problems, and a weakened immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The disease can lead to complications like anemia and high calcium levels in the blood. As it progresses, it becomes more challenging to manage and may require different therapeutic approaches.

Trial ID:

2023-506877-37-00

Protocol code:

207499

NCT ID:

NCT04484623

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Belantamab Mafodotin with Pomalidomide and Dexamethasone to Bortezomib with Pomalidomide and Dexamethasone for Patients with Relapsed/Refractory Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?