Comparison of intravenous versus subcutaneous isatuximab with lenalidomide, bortezomib and dexamethasone in newly diagnosed multiple myeloma patients eligible for transplant
This study focuses on treating patients with newly diagnosed Multiple Myeloma, a type of blood cancer that develops in plasma cells found in bone marrow. The research examines two different methods of administering isatuximab – either through intravenous infusion into a vein or by subcutaneous injection under the skin. Both methods will be combined with other medications including lenalidomide, bortezomib, and dexamethasone.
The main purpose of this research is to determine if giving isatuximab as an injection under the skin works as well as giving it through an intravenous infusion when combined with the other medications. The study will compare these two methods in patients who are eligible for stem cell transplantation.
During the treatment, patients will receive one of the two forms of isatuximab along with the standard combination of medications. The treatment period will last up to 18 months. Throughout the study, doctors will monitor how well the treatment is working by measuring the amount of myeloma cells in the body and checking for signs that the disease is responding to the therapy.
1Initial evaluation and diagnosis
Confirmation of multiple myeloma diagnosis requiring treatment
Medical assessment to confirm eligibility for high-dose therapy and stem cell transplant
Basic health checks including performance status evaluation
Required tests to measure disease markers in blood and urine
2Treatment assignment
Random assignment to one of two treatment groups
Both groups receive the same medications, but with different methods of isatuximab administration:
Group 1: isatuximab given through intravenous infusion (into a vein)
Group 2: isatuximab given through subcutaneous injection (under the skin)
3Induction therapy
Treatment with four medications:
– Isatuximab (either by intravenous infusion or subcutaneous injection)
– Lenalidomide (oral capsules in various strengths: 5mg, 10mg, 15mg, or 25mg)
– Bortezomib (Velcade) as subcutaneous injection
– Dexamethasone (oral or intravenous)
Regular monitoring of response to treatment
Assessment of disease status using blood and bone marrow tests
4Response evaluation
Assessment of treatment response after induction therapy
Evaluation of disease status using standard criteria
Bone marrow examination to check for remaining disease cells
Completion of questionnaire about satisfaction with therapy
Who Can Join the Study?
Must have a confirmed diagnosis of untreated Multiple Myeloma that requires treatment
Must be between 18 and 70 years old
Must provide written informed consent before joining the study
Must be eligible for high-dose melphalan therapy (a type of chemotherapy) and stem cell transplantation
Must have measurable disease, shown by at least one of these:
Blood protein level ≥ 10 g/L
Urine protein level ≥ 200 mg in 24 hours
Specific blood protein levels meeting certain criteria
Must have a WHO performance status of 0-2 (meaning ability to perform daily activities with minimal assistance)
Women who can become pregnant must have a negative pregnancy test
All men and women who can have children must use effective birth control during the entire treatment
Must agree not to donate blood during treatment with lenalidomide and for 28 days after stopping it
Must be able to understand the nature of the study and its consequences
Who Cannot Join the Study?
Prior treatment with any anti-myeloma therapy (except for emergency use of short-term steroids)
History of other cancer within 5 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ
Plasma cell leukemia (a rare and aggressive type of blood cancer where plasma cells are found in high numbers in the blood)
Known hypersensitivity (severe allergic reaction) to any of the study medications
Active or chronic hepatitis B or hepatitis C infection
Positive HIV test
Significant heart conditions including heart failure or recent heart attack (within 6 months)
Uncontrolled high blood pressure
Major surgery within 4 weeks before starting the study
Lenalidomide is a medication used to treat multiple myeloma. It works by helping the immune system fight cancer cells and by blocking the growth of new blood vessels that feed tumors.
Bortezomib is a targeted therapy that belongs to a class of drugs called proteasome inhibitors. It works by blocking certain proteins in cancer cells, causing them to die.
Dexamethasone is a corticosteroid medication that helps reduce inflammation and suppress the immune system. In cancer treatment, it’s often used to reduce side effects and enhance the effectiveness of other medications.
Isatuximab is an antibody therapy that targets a specific protein called CD38 found on the surface of multiple myeloma cells. It helps the immune system identify and destroy cancer cells. In this trial, it’s being tested in two different forms: one given through an intravenous (IV) infusion into the vein, and another given as a subcutaneous (SC) injection under the skin.
Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that produce antibodies. The disease begins when healthy plasma cells in the bone marrow become abnormal and multiply uncontrollably, forming tumors in multiple bones throughout the body. These cancerous cells produce abnormal proteins and interfere with the production of normal blood cells. As the disease progresses, it can weaken bones, cause anemia, reduce the body’s ability to fight infections, and affect kidney function. The abnormal plasma cells can crowd out healthy blood cells in the bone marrow and produce excessive amounts of a single type of antibody.
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