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CAR T Cell Therapy for Multiple Myeloma (KarMMa Trial)
KarMMa Trial Summary
This trial is testing a new cancer treatment involving CAR T cells. Lymphodepleting therapy will be used prior to infusion of the CAR T cells.
KarMMa Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowKarMMa Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.KarMMa Trial Design
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Who is running the clinical trial?
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- You have another type of cancer that has needed treatment in the past 3 years or is not fully under control.You did not respond well to the last treatment you received.You have been diagnosed with multiple myeloma and it is written in your medical records.You are allergic to any part of the bb2121 treatment, cyclophosphamide, fludarabine, or tocilizumab.You have had a stem cell transplant or gene therapy for cancer in the past.You must have tried at least 3 different treatments for multiple myeloma. If you had a stem cell transplant and/or maintenance therapy after your initial treatment, it still counts as one regimen.You currently have or have had plasma cell leukemia.You have a type of plasma cell cancer that is not easily measurable.You have evidence of an active hepatitis B virus infection in your blood.You have evidence of an active hepatitis B or C virus infection in your blood.You have had serious heart problems like severe heart failure, stroke, heart attack, or dangerous heart rhythm issues in the past 6 months.You must have tried at least two rounds of treatment for each plan, unless your condition got worse as the best response to the plan.You are currently taking medicine that weakens your immune system.You have been diagnosed with HIV.You have myeloma that has spread to your central nervous system.You have a history of important brain or spinal cord problems.Your organs don't work well enough.You must have already taken certain types of medications called proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody.You are in good enough health to carry out your usual activities without limitations (ECOG performance status 0 or 1).You must have a disease that can be measured, like a tumor or lesion that can be seen on a scan or felt by a doctor.You have a high level of M-protein in your blood.You have high levels of M-protein in your urine.Your blood test shows high levels of involved free light chains, and the ratio of certain proteins in your blood is abnormal.You must have recovered from any side effects of previous treatments, except for hair loss and mild nerve problems.
- Group 1: Administration of 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
Has the FDA authorized bb2121 for use?
"With the data from phase 2 trials, our team evaluated bb2121's safety to be a score of two. Despite this assessment, there is currently no clinical evidence proving efficacy."
What therapeutic purpose does bb2121 usually serve?
"bb2121 has been shown to be efficacious in the management of refractory multiple myeloma, as well as patients who previously received proteasome inhibitor or anti-cd38 monoclonal antibody treatments."
What is the geographical distribution of this research program?
"This research is taking place at Local Institution - 101 in Nashville, Tennessee; University of Texas Southwestern Medical Center in Dallas, Texas; and Local Institution - 108 in San Francisco, California. Additionally, 20 other clinical trial sites are being utilized for this investigation."
Is this particular experiment currently enrolling participants?
"This research project is not currently taking in candidates. It was initially published on December 13th of 2017 and the details were most recently revised on July 18th 2022. At present, there are 807 studies for multiple myeloma that accept participants and 8 trials for bb2121 still recruiting patients."
Is this an innovative research project?
"Currently, 8 trials for bb2121 are ongoing in 54 cities and 13 nations. Celgene initiated the initial pilot study back in 2015 with 67 participants that successfully completed Phase 1 drug approval. To date, no further studies have been concluded following this trial's completion five years ago."
Are there extant studies of bb2121's effectiveness?
"Initially investigated in 2015 by Beth Israel Deaconess Medical Center, bb2121 has yet to be completed for a full trial. Currently, 8 active clinical experiments are taking place with some of them based out Nashville, Tennessee."
What is the projected enrollment number for this research project?
"Patient recruitment for this trial has concluded. Initially posted on December 13th 2017, the study was last modified July 18th 2022. For individuals searching for other trials to join, there are presently 807 multiple myeloma clinical studies and 8 bb2121 related investigations actively recruiting patients."
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