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bb2121 for Multiple Myeloma (KarMMa-2 Trial)
KarMMa-2 Trial Summary
This trial is testing a new treatment for myeloma that has relapsed or is refractory. The trial will enroll approximately 235 subjects in 3 different cohorts.
KarMMa-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowKarMMa-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.KarMMa-2 Trial Design
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Who is running the clinical trial?
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- I haven't had certain treatments in the 2 weeks before my leukapheresis or giving consent.I do not have a history of severe illnesses, infections, or other health conditions listed.I am 18 years or older.Participants need to meet specific requirements for the type of multiple myeloma they have.I have recovered from side effects of previous treatments, except for hair loss and mild nerve pain.My disease can be measured by tests.I am fully active and can carry on all pre-disease activities without restriction.
- Group 1: Cohort 2a: BB2121 in multiple myeloma with Autologous stem cell transplantation participants
- Group 2: Cohort 2b: BB2121 in multiple myeloma without Autologous stem cell transplantation participants
- Group 3: Cohort 1: BB2121 in relapsed and refractory multiple myeloma participants
- Group 4: Cohort 3: BB2121 with lenalidomide maintenance in newly diagnosed multiple myeloma
- Group 5: Cohort 2c: BB2121 in multiple myeloma participants with inadequate response post ASCT
- Group 6: Cohort 1b: BB2121 with talquetamab in relapsed and refractory multiple myeloma participants
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
How many test subjects are in this experiment?
"That is correct, the relevant information on clinicaltrials.gov affirms that this study remains open and is actively recruiting participants. The trial was first advertised on December 13th, 2018 and received its most recent edit on June 23rd, 2022. A total of 235 patients are needed for the experiment, which will take place across 24 different locations."
Are investigators still looking for participants for this experiment?
"That is correct. The online clinicaltrial database has the latest information on this trial, which was originally posted on December 13th, 2018. As of June 23rd, 2022, the study is still looking for 235 patients from 24 different sites."
What are the typical conditions that bb2121 helps to improve?
"bb2121 is most often used to treat multiple myeloma that has not responded to other treatments. It can also be taken to treat patients that have previously undergone proteasome inhibitor treatment, anti-cd38 monoclonal antibody treatment, or who have had ≥4 lines of therapy."
Is this a novel clinical trial?
"Since 2015, bb2121 has undergone extensive clinical trials. The first sponsored by Celgene was completed in that same year and included 67 participants. Following the success of the initial study, Phase 1 drug approval was granted. Currently, there are 8 active global trials involving 54 cities and 13 countries."
Are there any sites running this trial in North America?
"This trial is being conducted at University of Texas Southwestern Medical Center in Dallas, Texas; Massachusetts General Hospital in Boston, Massachusetts; Dana Farber Cancer Institute in Seattle, Washington and additional 24 locations."
Are there any past case studies of bb2121's efficacy?
"The first trial for bb2121 was conducted in 2015 at Beth Israel Deaconess Medical Center. There have been no completed trials as of now, however there are 8 live studies with a large number being run out of Dallas, Texas."
What is the bb2121 drug's official government classification?
"bb2121 is still being tested for both efficacy and safety. However, there is already some data supporting its safety profile, so it received a score of 2."
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