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Study of belantamab mafodotin with drug combination for newly diagnosed multiple myeloma patients who cannot receive transplant

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with newly diagnosed multiple myeloma who cannot receive a transplant. The study tests a combination of several medications: belantamab mafodotin, lenalidomide, dexamethasone, and nirogacestat. Multiple myeloma is a type of blood cancer that affects plasma cells, which are cells in the bone marrow that help fight infections.

The purpose of this study is to determine if this combination of medications is safe and effective for treating patients with newly diagnosed multiple myeloma. The study will evaluate how well patients tolerate the treatment and measure how well the cancer responds to these medications when used together.

The treatment involves taking some medications by mouth (lenalidomide, dexamethasone, and nirogacestat) and receiving belantamab mafodotin through an intravenous infusion (through a vein). During the study, participants will receive regular medical check-ups and tests to monitor their health and evaluate how well the treatment is working. The study will last approximately four years.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your eligibility for the study will be determined through medical examinations and tests
The medical team will check your bone marrow and conduct blood tests to confirm multiple myeloma diagnosis
An eye examination will be performed to assess your baseline eye health
Step 2
Treatment combination
You will receive a combination of four medications:
Belantamab mafodotin - given through an intravenous infusion
Lenalidomide - taken by mouth
Dexamethasone - taken by mouth
Nirogacestat - taken by mouth
Step 3
Regular monitoring
Regular blood tests will be performed to monitor your response to treatment
Eye examinations will be conducted regularly to check for any vision-related changes
Bone marrow tests will be performed to assess your response to treatment when needed
Your overall health and any side effects will be monitored throughout the study
Step 4
Response assessment
Your response to treatment will be evaluated regularly using blood tests and other examinations
The medical team will assess if your disease is improving, stable, or progressing
If you achieve a very good response, additional testing may be done to check for remaining cancer cells
Step 5
Study completion
The study will continue until November 2026
Follow-up examinations will be conducted after treatment completion
Your final response to treatment will be assessed

Who can join the trial?

9 criteria

Must be over 18 years old
Must have multiple myeloma confirmed by at least 10% plasma cells in bone marrow or a proven tumor, along with one or more of these signs: - High calcium levels in blood - Kidney problems - Low red blood cell count (anemia) - Bone damage visible on scans
Must have measurable disease shown by at least one of these: - Certain proteins in urine - Specific protein levels in blood - Abnormal levels of light chains in blood
Not suitable for stem cell transplant due to other health conditions
Must have good enough physical function to perform daily activities (ECOG score of 0-2)
Must have adequate organ function, including: - Sufficient blood cell counts - Acceptable liver function - Kidney function above certain levels
For women who can become pregnant: - Must use two reliable birth control methods - Must have negative pregnancy tests before starting - Must not donate eggs during and after treatment
For men: - Must use effective contraception - Must not donate sperm during and after treatment
Must be able to understand and agree to study procedures by signing informed consent

Who cannot join the trial?

16 criteria

Age under 18 years old
Previous treatment for multiple myeloma, including chemotherapy, targeted therapy, or radiation therapy
Eligible for stem cell transplantation
Severe kidney problems (creatinine clearance less than 30 mL/min)
Active or chronic liver disease
Known active infection with HIV, Hepatitis B, or Hepatitis C
History of other cancers within the past 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
Significant heart conditions, including:
- Heart failure requiring treatment
- Heart attack within past 6 months
- Unstable heart rhythm problems
- Active or uncontrolled autoimmune conditions
- Known allergies to any of the study medications
- Pregnancy or breastfeeding
- Unable to understand or follow study instructions
- Participation in another clinical trial within 30 days before starting this study
- Any medical condition that the study doctor believes would make participation unsafe

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Verified sites

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Verified
Alexandra Hospital
Athens, Greece

Trial locations

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Investigated drugs

Belantamab mafodotin
is a medication used in cancer treatment, specifically for multiple myeloma. It works by targeting a specific protein on cancer cells to help destroy them while limiting damage to healthy cells.
Lenalidomide
is a medication that helps fight multiple myeloma by strengthening the immune system's ability to fight cancer cells and by preventing the growth of new blood vessels that feed tumors.
Dexamethasone
is a corticosteroid medication that helps reduce inflammation in the body and is commonly used in combination with other cancer treatments to enhance their effectiveness and manage side effects.
Nirogacestat
is an experimental medication that works by blocking specific signals that cancer cells use to grow and survive. It is being studied as part of combination therapy for multiple myeloma treatment.

What is already known about the treatment

Belantamab mafodotin
An innovative antibody-drug conjugate administered intravenously for the treatment of multiple myeloma. This medication targets B-cell maturation antigen (BCMA) on myeloma cells, delivering a potent cytotoxic agent directly to cancer cells while minimizing damage to healthy tissue. Currently being investigated in clinical trials for newly diagnosed multiple myeloma patients who are ineligible for transplant.
Lenalidomide
An oral immunomodulatory drug used in the treatment of multiple myeloma. It works by enhancing the immune system's ability to fight cancer cells and inhibiting the growth of blood vessels that support tumor development. This medication is commonly used in combination therapy regimens and has shown significant effectiveness in treating various stages of multiple myeloma.
Dexamethasone
An oral or injectable corticosteroid medication that helps reduce inflammation and suppress immune system activity in multiple myeloma treatment. It is frequently used in combination with other anti-cancer medications to enhance their effectiveness and manage symptoms. This medication works by decreasing the body's immune response and reducing inflammation in various tissues.
Nirogacestat
An oral gamma secretase inhibitor being investigated in clinical trials for multiple myeloma treatment. This medication works by blocking specific cellular signaling pathways involved in cancer cell growth and survival. It is being studied in combination with other medications to potentially enhance the effectiveness of multiple myeloma treatment in newly diagnosed patients.

Investigated diseases

Multiple Myeloma - A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. In this condition, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells. These abnormal cells produce large amounts of defective antibodies called M proteins. The disease can cause bone pain, weakened bones, fatigue, frequent infections, and kidney problems. Multiple myeloma typically progresses slowly and can affect multiple areas of the body, particularly the bones.