This clinical trial is focused on studying a condition called Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is testing different treatments to see how effective and safe they are for people whose disease has returned or has not responded to previous treatments. The treatments being tested include a new medication called Elranatamab (also known by its code name PF-06863135), which is given as an injection. The study will also look at the combination of Elranatamab with another medication called Daratumumab, and compare it to a combination of Daratumumab with two other drugs, Pomalidomide and Dexamethasone.
The purpose of the study is to find out which treatment works best for patients with relapsed or refractory Multiple Myeloma. Participants in the study will be randomly assigned to one of three groups. One group will receive Elranatamab alone, another group will receive Elranatamab combined with Daratumumab, and the third group will receive Daratumumab combined with Pomalidomide and Dexamethasone. The study will monitor the participants over a period of time to see how their disease responds to the treatment and to check for any side effects.
Throughout the study, participants will receive regular check-ups and tests to monitor their health and the progress of their treatment. The study aims to provide valuable information that could help improve treatment options for people with Multiple Myeloma in the future. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, prior diagnosis of multiple myeloma, and previous treatments.
Participants must have measurable disease and meet health requirements such as adequate heart, liver, and kidney function.
2treatment assignment
Participants are randomly assigned to one of three treatment groups: elranatamab alone, elranatamab with daratumumab, or daratumumab with pomalidomide and dexamethasone.
3treatment administration
For those receiving elranatamab, it is administered as a subcutaneous injection.
Participants in the daratumumab group receive it as a subcutaneous injection.
Those in the pomalidomide and dexamethasone group take these medications orally, with pomalidomide available in 1 mg, 2 mg, 3 mg, and 4 mg capsules, and dexamethasone as 40 mg tablets.
4monitoring and assessments
Participants undergo regular monitoring to assess the safety and effectiveness of the treatment.
This includes checking for any side effects and measuring the response to treatment using specific criteria.
5end of treatment
The study continues until the estimated end date in September 2026, or until the treatment is no longer beneficial.
Participants may continue to be monitored for long-term effects and overall health outcomes.
Who Can Join the Study?
Participants must be 18 years or older.
Must have a prior diagnosis of multiple myeloma, a type of blood cancer.
Must have a measurable disease based on specific criteria, such as certain levels of proteins in the blood or urine.
Must have had previous treatments for multiple myeloma:
For Part 1: At least 3 previous treatments, including specific drugs like lenalidomide and a proteasome inhibitor (PI).
For Part 2: Between 1 and 3 previous treatments, including lenalidomide and a PI, with a positive response to any of these treatments.
Must have an ECOG performance status of less than 2, which means they should be able to carry out daily activities with some limitations.
Must have a left ventricular ejection fraction (LVEF) of 40% or higher, which is a measure of heart function.
Must have adequate liver, kidney, and bone marrow function.
Must have normal levels of calcium in the blood.
Any side effects from previous treatments must have returned to normal or be mild.
Who Cannot Join the Study?
Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had another type of cancer within the last 5 years, except for certain skin cancers or in situ cervical cancer.
Patients who have had a recent infection that required treatment with antibiotics, antivirals, or antifungals.
Patients who have received certain treatments for multiple myeloma within a specific time frame before the study.
Patients with known allergies to the study drugs or similar drugs.
Patients who have participated in another clinical trial within a certain period before this study.
Patients with certain heart conditions or who have had a heart attack within the last 6 months.
Patients with uncontrolled high blood pressure.
Patients with certain lung conditions that could affect breathing.
Patients with liver or kidney problems that are not well controlled.
Patients with a history of drug or alcohol abuse within the last 2 years.
Patients who are unable to follow the study procedures or attend the required visits.
Elranatamab (PF-06863135) is a medication being studied for its potential to treat multiple myeloma, a type of blood cancer. In this trial, it is being tested both on its own and in combination with another medication to see how well it works and how safe it is for patients who have already tried other treatments.
Daratumumab is a medication used to treat multiple myeloma. It works by helping the immune system to find and destroy cancer cells. In this study, it is being used in combination with other medications to see if it can improve treatment outcomes for patients.
Pomalidomide is a medication that helps the immune system fight cancer and is used to treat multiple myeloma. In this trial, it is combined with other drugs to evaluate its effectiveness in patients who have not responded well to previous treatments.
Dexamethasone is a type of steroid that reduces inflammation and is used in combination with other medications to treat multiple myeloma. In this study, it is part of a treatment regimen to assess its role in improving patient outcomes.
Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. These cancerous plasma cells multiply rapidly and produce abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can lead to bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also interfere with the production of normal blood cells, leading to further complications. Over time, the disease can cause significant damage to various organs and systems in the body.
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