Study on Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a disease called Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The trial is testing a treatment known as Belantamab Mafodotin, also referred to by its code name GSK2857916. This treatment is given as a powder that is mixed into a solution and then injected into the bloodstream. The purpose of the study is to explore different ways of giving this treatment to see how safe and effective it is for people whose multiple myeloma has returned or has not responded to previous treatments.

Participants in the study will receive the treatment in one of several different dosing schedules. The study will monitor the effects of the treatment over time, particularly focusing on any changes in the eyes, as these are known to be a possible side effect. The study will also look at how the treatment moves through the body and how the body responds to it. Participants will be observed for any side effects and how well the treatment works in controlling the disease.

The trial will continue for a set period, during which participants will have regular check-ups and tests to track their health and the progress of their multiple myeloma. The study aims to gather information that could help improve treatment options for people with this condition in the future.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose and procedures. The participant must provide signed informed consent, confirming understanding and agreement to comply with the study requirements.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of multiple myeloma and ensuring the participant meets specific health criteria, such as performance status and previous treatment history.

3 treatment administration

The participant will receive belantamab mafodotin, a medication administered as a powder for solution for injection through intravenous use. The dosing regimen will vary depending on the study arm assigned to the participant.

4 monitoring and follow-up

Regular monitoring will occur to assess the participant’s response to the treatment and to identify any side effects, particularly corneal events. The frequency and duration of these assessments will be determined by the study protocol.

5 completion of treatment

Upon completion of the treatment phase, a final evaluation will be conducted to assess the overall impact of the medication on the participant’s condition and to document any lasting effects.

6 end of study participation

The participant’s involvement in the study will conclude after the final evaluation. The participant will be informed about the study’s findings and any further steps, if applicable.

Who Can Join the Study?

Participant must be at least 18 years old at the time of signing the consent form.
Participant must meet any specific criteria required by their country, if applicable.
Participant must have an ECOG performance status of 0 to 2, which is a scale used to assess how a disease affects a patient’s daily living abilities.
Participant must have a confirmed diagnosis of multiple myeloma, a type of blood cancer, and must have either undergone a stem cell transplant or be considered ineligible for one. They must have tried at least three previous treatments, including a specific type of antibody treatment, and not responded to certain other medications.
Participant must have measurable disease, which means the disease can be measured using specific tests like blood or urine tests.
Participants who have had a stem cell transplant are eligible if the transplant was done more than 100 days before joining the study, they have no active infections, and they meet all other criteria.
Any side effects from previous treatments must be mild (Grade 1 or less) at the time of joining the study, except for hair loss and moderate nerve damage.
Participant must have a life expectancy of at least 6 months, as judged by the study doctor.
Participants must follow local rules for contraception. Women must not be pregnant or breastfeeding and must use effective birth control if they can have children. Men must agree to use contraception and not donate sperm during the study and for a period after.
Participant must be able to give informed consent, meaning they understand the study and agree to follow its rules.

Who Cannot Join the Study?

Patients who have a different condition than Multiple Myeloma cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Both male and female patients are considered, but those who do not meet other criteria cannot participate.
Patients who are part of a vulnerable population may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Centre Antoine Lacassagne	Nice	France
Hospital General Universitario De Albacete	Albacete	Spain
Centre Hospitalier D Avignon	Avignon	France
Evangelismos S.A.	Athens	Greece
Alexandra Hospital	Athens	Greece
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
General University Hospital Of Patras	Patras	Greece
Fundacio Assistencial De Mutua De Terrassa Fpc	Terrassa	Spain
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Beaumont Hospital	Dublin	Ireland
Atiohqi Oxafwojqqlp Nejaqdboh Sr Ajlghof E Brcpdb E C Appshf Axyxtqlaakk	Alexandria	Italy
Hiapabve De Lr Skprt Caub I Sttf Prh	Barcelona	Spain
Ipxgraot Cxaddh Dxdljfpvgrcaiveyl	L'hospitalet De Llobregat	Spain
Uikklekrfj Gxnwrfi Hynfuqov Axefzlr	Athens	Greece

Trial status

Country	Status	Recruitment Start
France	Not recruiting	03.03.2022
Germany	Not recruiting	03.03.2022
Greece	Not recruiting	03.03.2022
Ireland	Not recruiting	03.03.2022
Italy	Not recruiting	03.03.2022
Poland	Not recruiting	03.03.2022
Spain	Not recruiting	03.03.2022

Trial locations

Investigated drugs:

Belantamab Mafodotin

Belantamab Mafodotin (GSK2857916) is a medication being studied for its effects on patients with relapsed or refractory multiple myeloma, a type of blood cancer. This medication is designed to target and kill cancer cells. The study aims to understand how different dosing schedules of this medication affect the eyes, specifically looking at any corneal events, which are changes or issues that might occur in the cornea, the clear front part of the eye.

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can result in bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also lead to a decrease in the production of normal blood cells, causing fatigue and weakness. Over time, the disease can cause significant complications, including kidney dysfunction and bone lesions.

Trial ID:

2023-508213-16-00

Protocol code:

209628

NCT ID:

NCT05064358

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma

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