Study Comparing Elranatamab, Daratumumab, and Lenalidomide with Daratumumab, Lenalidomide, and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma
This clinical trial is focused on studying a disease called Multiple Myeloma, which is a type of cancer that affects the blood. The study is testing different combinations of treatments to see which works best for people who cannot have a transplant. The treatments being studied include Elranatamab (also known by its code name PF-06863135), Daratumumab, Lenalidomide, and Dexamethasone. These medications are used to help control the disease and improve the quality of life for patients.
The purpose of the study is to compare the effectiveness and safety of two different treatment combinations. One group will receive Elranatamab, Daratumumab, and Lenalidomide, while the other group will receive Daratumumab, Lenalidomide, and Dexamethasone. The study will follow participants over a period of time to see how well the treatments work and to monitor any side effects. Participants will receive their treatments either as tablets, capsules, or injections, depending on the medication.
Throughout the study, participants will have regular check-ups to monitor their health and the progress of their treatment. The study aims to find out which combination of treatments is more effective in managing Multiple Myeloma for those who are not eligible for a transplant. This research is important for improving treatment options and outcomes for patients with this condition.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and diagnosis of multiple myeloma.
Participants are divided into two groups for the study: one group receives a combination of elranatamab, daratumumab, and lenalidomide, while the other group receives daratumumab, lenalidomide, and dexamethasone.
2treatment phase
Participants in the first group receive elranatamab as a solution for injection, daratumumab as a subcutaneous injection, and lenalidomide in capsule form for oral use.
Participants in the second group receive daratumumab as a subcutaneous injection, lenalidomide in capsule form for oral use, and dexamethasone in tablet form for oral use.
The treatment is administered over a specified period, with regular monitoring to assess the body’s response and any side effects.
3monitoring and assessment
Throughout the study, regular assessments are conducted to monitor the effectiveness of the treatment and any adverse effects.
These assessments include blood tests, imaging studies, and other evaluations to measure disease progression and response to treatment.
4completion of the study
Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the treatment.
Participants may be offered follow-up care or additional treatment options based on the results of the study.
Who Can Join the Study?
Participants must be at least 18 years old, or the minimum age of consent in their country if it’s higher than 18.
For Part 2 only: Participants should have newly diagnosed multiple myeloma (NDMM) and be unable to have a transplant. This could be due to being 65 years or older, or being younger than 65 with other health issues that make a transplant not possible.
Participants should have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. This is a scale that measures how well a person can perform daily activities.
Participants need to have proper liver, kidney, and bone marrow function. This includes having enough white blood cells, platelets, and hemoglobin, which is a protein in red blood cells.
Participants should have normal levels of calcium in their blood.
Any side effects from previous treatments should have returned to normal or be mild.
Participants must have a diagnosis of multiple myeloma, which is a type of blood cancer, according to specific criteria.
Participants should have measurable disease, meaning the cancer can be measured in some way, according to specific criteria.
For Part 1 only: Participants can have newly diagnosed multiple myeloma (NDMM) or relapsed/refractory multiple myeloma (RRMM). NDMM participants must be unable to have a transplant due to age or other health issues. RRMM participants should have had 1-2 previous treatments, including at least one type of drug that affects the immune system and one that targets proteins in cells.
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.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have had a major surgery within the last 4 weeks.
Patients who are currently participating in another clinical trial.
Patients who have a history of allergic reactions to similar medications used in the study.
Patients with uncontrolled high blood pressure or heart problems.
Patients with liver or kidney problems that are not stable.
Patients who have a history of drug or alcohol abuse.
Elranatamab (PF-06863135) is an investigational medication being studied for its potential to treat multiple myeloma. It is being tested in combination with other medications to see if it can help improve outcomes for patients who are not eligible for a transplant.
Daratumumab is a medication used to treat multiple myeloma. It works by targeting a specific protein on the surface of myeloma cells, helping the immune system to destroy them. In this trial, it is used in combination with other medications to evaluate its effectiveness in newly diagnosed patients.
Lenalidomide is a medication that helps the immune system fight cancer cells and is commonly used in the treatment of multiple myeloma. It is being used in this study to see how well it works with other medications in treating patients who cannot undergo a transplant.
Dexamethasone is a type of steroid that helps reduce inflammation and is often used in combination with other cancer treatments. In this trial, it is part of a treatment regimen to assess its role in improving patient outcomes when used with other medications for multiple myeloma.
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 slowly, but it can become more aggressive in some cases.
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