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CAR T Cells +/− Lenalidomide for Multiple Myeloma
Study Summary
This trial is testing if CAR T cells are safe for patients with myeloma. In the first part of the study, they screen patients and collect cells. In the second part of the study, they treat patients with the CAR T cells.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I do not have any active cancer needing treatment except for skin cancer.My heart's pumping ability is below normal.I do not have HIV or active hepatitis B or C.I had an allogeneic transplant but haven't needed systemic treatment for GvHD.I need assistance with my daily activities.Your blood levels of hemoglobin, white blood cells, and platelets are within a certain range without needing extra blood or medication for at least 1 week.I am 18 years old or older.I do not have any current severe infections that aren't under control.Your creatinine and bilirubin levels are not too high, and your liver enzymes (AST and ALT) are within a certain range.My oxygen levels are 92% or higher without extra oxygen.I have not taken steroids in the last two weeks, except for adrenal replacement.I have been diagnosed with plasma cell leukemia.I do not have any severe or active neurological disorders.I am not pregnant or breastfeeding and will use birth control during and for 1 year after the study.I have been treated with gene-modified T cells before.My myeloma has or had spread to my brain or spinal cord.You have an ongoing autoimmune disease or a history of a severe autoimmune disease that needed long-term treatment to suppress the immune system.I cannot take Lenalidomide due to intolerance or contraindication but can receive CAR T cell therapy.I have multiple myeloma with BCMA, treated with 2+ therapies including an IMiD and a PI, and my disease is not improving.You have a high level of M protein or abnormal free light chain levels in your blood.
- Group 1: BCMA Targeted CAR T Cells with or without Lenalidomide
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the benefits of EGFRt/BCMA-41BBz CAR T cell therapy?
"EGFRt/BCMA-41BBz CAR T cell therapy can help patients with chronic lymphocytic leukemia, who have undergone at least two systemic chemotherapy regimens, and those with lung cancers."
What are the risks associated with EGFRt/BCMA-41BBz CAR T cell treatment?
"Given that this is a Phase 1 clinical trial with limited data to support efficacy and safety, our team has given EGFRt/BCMA-41BBz CAR T cell a score of 1."
Are there other examples of this kind of CAR T cell clinical trial?
"As of right now, there are 1088 active clinical trials studying EGFRt/BCMA-41BBz CAR T cell with 212 trials in Phase 3. While most of the clinical trials for EGFRt/BCMA-41BBz CAR T cell are running out of in Philadelphia, Pennsylvania, there are 39306 locations running trials for EGFRt/BCMA-41BBz CAR T cell."
Are new volunteers being accepted into this experiment?
"According to the latest information available on clinicaltrials.gov, this particular medical study is not currently looking for new participants. The trial was originally posted on February 27th, 2017 and was last edited on March 7th, 2022. There are 1914 other studies that are actively recruiting patients right now."
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