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CAR-T Therapy for Multiple Myeloma
Study Summary
This trial will test a new treatment for multiple myeloma that uses the patient's own cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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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- You have had a previous allogeneic hematopoietic cell transplant.I stopped taking lenalidomide permanently due to severe side effects.My multiple myeloma does not produce detectable levels of M protein.I have a significant brain or nervous system condition.Your blood clotting time is not too fast.I am 18 years old or older.I haven't had serious heart issues like heart failure or a heart attack in the last 6 months.I have HIV, hepatitis B, hepatitis C, or acute hepatitis A.I am currently on long-term immunosuppressant medication.I am unwilling to take blood clot prevention medication while on my cancer treatment.I have had significant bleeding in the last 30 days.I have had cancer before, but it was either skin cancer removed by surgery or a localized cancer that was treated without spreading.My kidney function, measured by creatinine clearance, is good.My initial treatment for myeloma didn't fully clear the cancer.I have or had a rare blood disorder like plasma cell leukemia or Waldenstrom's.I started lenalidomide-based therapy within 6 months after my stem cell transplant and have been on it for at least 3 months.I have symptoms from my multiple myeloma that need treatment.I am not pregnant, can follow strict birth control measures, and will not breastfeed during the study period.I am a woman who could potentially become pregnant.I am on a long-term blood thinner medication.You have a serious autoimmune disease that is currently active.Your oxygen level is higher than 92% without needing extra oxygen.I haven't had major treatments or taken new drugs for myeloma in the last 2 weeks.My multiple myeloma has spread to my brain or spinal cord.I have enough stored stem cells for my body weight.I have never had gene therapy, cellular therapy, or BCMA targeted therapy for cancer.I've had initial treatment for myeloma, including high-dose melphalan and a stem cell transplant within the last year.I do not have any uncontrolled infections.I had a stem cell transplant using my own cells less than 12 months ago.I am mostly able to care for myself.My hemoglobin level is above 9 g/dL without recent blood transfusions.I have recovered from side effects of previous treatments, except for mild neuropathy.My white blood cell count is healthy without needing medication in the last 2 weeks.My platelet count is over 100,000 without recent transfusions or medications.Your corrected serum calcium level is 13.5 mg/dL or lower.My heart pumps well, with an ejection fraction over 45%.My liver tests are within normal limits, or I have Gilbert's disease.I am a male willing to use a condom during sex with a woman who could become pregnant for at least 1 year after treatment, and I won't donate sperm during this time.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I cannot or do not want to return to the transplant center for treatment or follow-up.I have taken lenalidomide 5 mg/day for more than 2 cycles without severe side effects.I have had an organ transplant and am on immunosuppressive drugs.I had blood clots while on blood thinners during previous IMiD treatment.My condition has worsened before joining this study.
- Group 1: Lenalidomide and bb2121
- 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
Does age limit a person's ability to participate in this research?
"The age requirements for potential participants in this study are between 18-71 years old."
What is the current status of lenalidomide and bb2121 in terms of FDA approval?
"Lenalidomide and bb2121 have some data backing its safety, but there is not yet any evidence that it is an effective medication. This gives it a Power team safety score of 2."
Can patients sign up for this clinical trial right now?
"This clinical trial, as reported on clinicaltrials.gov, is actively recruiting participants. The original posting was on 1/5/2022, and the most recent update was on 9/22/2022."
How many different hospitals are conducting this trial?
"At the moment, this research is being conducted out of 16 different sites. They are situated in New york, Madison, Milwaukee and a selection of other cities. If you're interested in participating it would be ideal to choose a location near to you in order to limit travel."
What are lenalidomide and bb2121 used to treat?
"Lenalidomide and bb2121 is a immunomodulatory treatment that has shown efficacy in patients with at least two prior systemic chemotherapy regimens, ≥4 prior lines of therapy, amyloidosis."
Are there other research projects that have looked at Lenalidomide and bb2121?
"The first clinical trial evaluating the lenalidomide and bb2121 combination was conducted in 2004 at Saint Joseph Regional Medical Center-Mishawaka. In total, there have been 346 completed studies investigating this treatment option. As of now, 278 trials are still ongoing with a large number of these based out of New york City."
Why did researchers design this trial in this way?
"The primary objective of this trial is to assess the efficacy of BCMA CAR-T cell therapy over the course of one year. Secondary objectives include measuring disease progression (using the International Myeloma Working Group response categories) and non-relapse mortality rates."
Might I be able to join this research project?
"This study is investigating whether lenalidomide can be an effective treatment for multiple myeloma in patients who have already undergone stem cell transplantation. The trial is looking for 40 participants between the ages of 18 and 71 who meet the following criteria: -Patients must have initiated maintenance therapy with lenalidomide-based regimen within 6 months after the auto HCT and have received at least 3 months of maintenance prior to enrollment.-Patients must have tolerated a minimum dose of lenalidomide 5 mg/day for 21 days of a 28-day cycle for greater than 2 cycles without having to stop due to"
How many people are allowed to join this trial?
"In order to accurately test the efficacy of the proposed intervention, 40 individuals that meet specific prerequisites are required. These potential participants can be located at different sites, such as Memorial Sloan Kettering Cancer Center in New york or University of Wisconsin Hospitals and Clinics in Madison."
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