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CAR T-cell Therapy
CAR T Cells +/− Lenalidomide for Multiple Myeloma
Phase 1
Waitlist Available
Led By Sham Mailankody, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for adults over 18 with Multiple Myeloma, who've had at least two prior treatments including specific therapies (IMiD and PI), and have persistent or worsening disease. They must have adequate organ function and not be pregnant, without certain severe health conditions like heart issues, active infections, or other cancers needing treatment.
What is being tested?
The study tests the safety of BCMA-targeted CAR T cells in treating myeloma. It has two parts: screening/assignment/cell collection and then treatment with modified CAR T cells. Some patients will also receive Lenalidomide to see if it improves outcomes.
What are the potential side effects?
Potential side effects include immune reactions from the CAR T cells that can affect different organs, symptoms related to infusion such as fever or chills, blood cell count changes leading to increased infection risk or bleeding problems, fatigue, and possible allergic reactions to Lenalidomide.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
MTD of gene-modified T cells
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BCMA Targeted CAR T Cells with or without LenalidomideExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Find a Location
Who is running the clinical trial?
Juno Therapeutics, Inc.Industry Sponsor
7 Previous Clinical Trials
789 Total Patients Enrolled
2 Trials studying Multiple Myeloma
47 Patients Enrolled for Multiple Myeloma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,965 Previous Clinical Trials
597,000 Total Patients Enrolled
86 Trials studying Multiple Myeloma
86,379 Patients Enrolled for Multiple Myeloma
Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyIndustry Sponsor
15 Previous Clinical Trials
2,147 Total Patients Enrolled
6 Trials studying Multiple Myeloma
878 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: BCMA Targeted CAR T Cells with or without Lenalidomide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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