This clinical trial is focused on studying Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study will explore the effectiveness of different treatment strategies using several medications. The main treatments being tested include Isatuximab (also known as SAR650984), which is a humanized monoclonal antibody targeting a protein called CD38, and Lenalidomide, a drug that modifies the immune system. Additionally, Iberdomide (CC-220) and Carfilzomib (PR-171) are also part of the study. These medications are used in various forms such as solutions for infusion, injections, and capsules.
The purpose of the study is to determine the best treatment approach for patients with Multiple Myeloma who are eligible for a procedure called autologous stem cell transplantation. The study will compare different combinations of the medications to see which is more effective in reducing the presence of cancer cells in the bone marrow, a state known as minimal residual disease (MRD) negativity. The trial will involve different groups of patients receiving different treatment plans, including high-dose therapy and additional cycles of the medication combinations.
Participants in the study will receive treatments over a period of time, with some receiving intravenous infusions and others taking oral medications. The study aims to increase the rate of MRD negativity before maintenance therapy, which is a phase of treatment aimed at keeping the cancer from returning. The trial will also look at the long-term outcomes such as overall survival and progression-free survival, which measures the time during and after treatment that a patient lives with the disease without it getting worse. The study is expected to continue until 2028.
1joining the study
Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Consent is required to participate, ensuring understanding of the study’s nature and the ability to withdraw at any time.
2initial treatment phase
The patient will begin treatment with a combination of medications. This includes isatuximab administered as an intravenous infusion, lenalidomide taken orally in capsule form, and carfilzomib given as an intravenous infusion.
The specific dosages and frequency of administration will be determined by the study protocol and the patient’s response to treatment.
3monitoring and assessment
Throughout the trial, the patient’s health and response to treatment will be closely monitored. This includes regular medical assessments and laboratory tests to evaluate the effectiveness of the treatment and any side effects.
4adjustment of treatment
Based on the patient’s response, the treatment plan may be adjusted. This could involve changes in medication dosage or the introduction of additional cycles of treatment.
The goal is to achieve a state known as minimal residual disease (MRD) negativity, which indicates a very low level of cancer cells.
5maintenance phase
If the patient achieves MRD negativity, they will enter a maintenance phase. This phase involves continued treatment to maintain the achieved response and prevent relapse.
The specific medications and duration of this phase will depend on the patient’s condition and the study’s requirements.
6follow-up and conclusion
After completing the treatment phases, the patient will undergo follow-up assessments to monitor long-term outcomes and overall survival.
The study is expected to conclude by September 2028, with ongoing analysis of the collected data to evaluate the effectiveness of the treatment strategies.
Who Can Join the Study?
Participants must be male or female and 18 years or older, but younger than 66 years.
Participants must provide voluntary written consent before any study-related procedures that are not part of normal medical care. They can withdraw consent at any time without affecting future medical care.
Participants must have documented symptomatic multiple myeloma, which is a type of blood cancer. This must meet certain criteria, such as having a specific percentage of abnormal plasma cells in the bone marrow or certain symptoms like high calcium levels, kidney issues, anemia, or bone lesions.
Participants must be newly diagnosed and eligible for high-dose therapy and autologous stem cell transplantation (a procedure where a patient’s own stem cells are used).
Participants must have an ECOG performance status of 2 or less, which means they are able to carry out all self-care but are unable to carry out any work activities. They are up and about more than 50% of waking hours.
Participants must have certain pretreatment clinical laboratory values, such as:
Hemoglobin levels of at least 7.5 g/dL.
Absolute neutrophil count (a type of white blood cell) of at least 1.0 Giga/L.
ASAT and ALAT (liver enzymes) levels no more than 3 times the upper limit of normal.
Total bilirubin no more than 3 times the upper limit of normal, unless they have a condition like Gilbert syndrome.
eGFR (a measure of kidney function) of at least 40 mL/min/1.73 m².
Albumin corrected serum calcium no more than 14 mg/dL or free ionized calcium no more than 6.5 mg/dL.
Platelet count of at least 50 Giga/L, or 30 Giga/L if a high percentage of bone marrow cells are plasma cells.
Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use two methods of birth control during the study and for a period after the study.
Men must agree not to father a child and use a latex condom during the study and for a period after the study, even if they have had a vasectomy. They must also agree not to donate sperm during this time.
Who Cannot Join the Study?
Patients who have a different type of cancer other than Multiple Myeloma.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who are not able to follow the study procedures or instructions.
Patients who have any medical condition that the study doctors think might make it unsafe for them to participate.
Patients who are currently participating in another clinical trial.
Patients who have had certain treatments or medications that might interfere with the study results.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to the study medications.
Patients who have any other health issues that the study doctors believe could affect the study outcomes.
Isa-KRD is a combination therapy used in the trial. It includes several medications that work together to treat patients. This combination is used to help increase the rate of minimal residual disease (MRD) negativity in patients after induction therapy. The goal is to improve the effectiveness of the treatment before maintenance therapy.
High-dose therapy and ASCT refers to a treatment approach that involves giving patients high doses of chemotherapy followed by an autologous stem cell transplant (ASCT). This method is used to increase the rate of MRD negativity in patients who are MRD negative after induction therapy. The high-dose therapy aims to eliminate remaining cancer cells, and the stem cell transplant helps restore healthy blood cells.
Tandem ASCT involves two consecutive autologous stem cell transplants. This approach is used for patients who are MRD positive after induction therapy. The goal is to increase the rate of MRD negativity by providing an additional opportunity to eliminate cancer cells with a second transplant.
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 cells become abnormal and multiply uncontrollably, leading to the production of a large amount of abnormal proteins. As the disease progresses, it can cause damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. Over time, the accumulation of abnormal plasma cells can lead to anemia and other blood-related issues. The disease often progresses in stages, with periods of stability followed by periods of active disease.
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