This clinical trial is focused on studying a condition known as Relapsed/Refractory Multiple Myeloma, which is a type of blood cancer that has returned or is not responding to treatment. The study aims to compare the effectiveness of a new treatment called Elranatamab against other treatment combinations. These combinations include Elotuzumab, Pomalidomide, and Dexamethasone (EPd); Pomalidomide, Bortezomib, and Dexamethasone (PVd); or Carfilzomib and Dexamethasone (Kd). The purpose of the study is to see how well these treatments work in people who have already received a specific type of therapy known as anti-CD38 directed therapy.
Participants in the study will receive one of these treatments and will be monitored over a period of time to assess the treatment’s effectiveness and safety. The study will involve regular check-ups and assessments to track the progress of the disease and any side effects that may occur. The study is designed to provide valuable information on how these treatments compare in terms of helping patients live longer without the disease getting worse.
The trial will continue until the estimated end date in 2029, with recruitment of participants expected to start in 2024. This study is important for understanding better treatment options for people with Relapsed/Refractory Multiple Myeloma and aims to improve the quality of life and outcomes for those affected by this condition.
1initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.
Eligibility criteria include a prior diagnosis of multiple myeloma and previous treatment with specific therapies.
2treatment assignment
Participants are assigned to one of two treatment groups: elranatamab monotherapy or a combination therapy group.
The combination therapy group may include elotuzumab, pomalidomide, dexamethasone (EPd), pomalidomide, bortezomib, dexamethasone (PVd), or carfilzomib, dexamethasone (Kd).
3medication administration
For those in the elranatamab group, the medication is administered via injection.
Participants in the combination therapy group receive medications orally or through injection, depending on the specific drugs assigned.
4monitoring and follow-up
Regular monitoring is conducted to assess the effectiveness of the treatment and any side effects.
This includes blood tests, imaging studies, and other assessments as needed.
5end of treatment evaluation
At the end of the treatment period, a comprehensive evaluation is performed to determine the overall response to the therapy.
This includes measuring progression-free survival and overall survival rates.
6long-term follow-up
Participants may be followed for an extended period to monitor long-term outcomes and any late-emerging effects of the treatment.
This phase may continue until the estimated end date of the study in January 2029.
Who Can Join the Study?
Participants must be 18 years or older at the time of screening.
Must have a prior diagnosis of multiple myeloma (a type of blood cancer) and have received at least 1 but not more than 4 previous treatments for it.
Must have had at least 2 cycles of treatment with an anti-CD38 antibody (a type of medication) and 2 cycles with lenalidomide (another type of medication) in any previous treatment.
Must show evidence of the disease getting worse or not responding to the last treatment, as determined by a doctor.
Must have a measurable disease, which means certain levels of myeloma protein in the blood or urine, or specific levels of free light chains (parts of antibodies) in the blood.
Must have a corrected serum calcium level of 14 mg/dL or less, or free ionized calcium of 6.5 mg/dL or less. These are measures of calcium in the blood.
Must have adequate bone marrow function, which means having enough blood cells like white blood cells, platelets, and hemoglobin.
Must have an ECOG performance status of less than 2, which is a scale used to assess how well a person can perform daily activities.
Who Cannot Join the Study?
Patients who have a different type of cancer other than Relapsed/Refractory Multiple Myeloma cannot participate. Relapsed/Refractory Multiple Myeloma is a 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 is open to certain age groups only.
Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have participated in another clinical trial recently may not be eligible to join this study.
Patients who have certain medical conditions that could interfere with the study or make it unsafe for them to participate cannot join.
Patients who are taking medications that could interfere with the study treatments may not be eligible.
Elranatamab is a medication being studied as a single treatment option for patients with relapsed refractory multiple myeloma. It is being tested to see how effective it is compared to other treatment combinations. Elranatamab works by targeting specific proteins on cancer cells, aiming to help the immune system recognize and attack these cells.
Elotuzumab is part of a combination treatment being compared in the study. It is used alongside other medications to treat multiple myeloma. Elotuzumab helps the immune system find and destroy cancer cells by targeting a specific protein on their surface.
Pomalidomide is another medication used in combination treatments for multiple myeloma. It works by affecting the immune system and directly attacking cancer cells, helping to slow down or stop their growth.
Dexamethasone is a steroid used in combination with other cancer treatments. It helps reduce inflammation and can also help kill cancer cells, making other treatments more effective.
Bortezomib is a medication used in combination therapies for multiple myeloma. It works by interfering with the growth of cancer cells, leading to their death. It is often used when other treatments have not been successful.
Carfilzomib is another medication used in combination treatments for multiple myeloma. It targets and disrupts the function of certain proteins within cancer cells, leading to their death and helping to control the disease.
Relapsed/Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In relapsed or refractory cases, the disease has returned after treatment or does not respond to standard therapies. It typically progresses by causing damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The disease can lead to anemia and high levels of calcium in the blood. Over time, it can become more challenging to manage as it becomes resistant to treatments.
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