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CAR T-cell Therapy
CAR T Cell Therapy for Multiple Myeloma (KarMMa Trial)
Phase 2
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
Must be refractory to the last treatment regimen.
Must not have
Ongoing treatment with chronic immunosuppressants
Subjects with known central nervous system involvement with myeloma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum of 24 months post-bb2121 infusion
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for adults over 18 with multiple myeloma that's come back or hasn't responded to treatment. They must have tried at least three different treatments, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Participants need measurable levels of the disease in their blood or urine and should be fairly healthy otherwise (ECOG status 0 or 1). Pregnant women, those with CNS involvement by myeloma, certain infections like HIV/HBV/HCV, severe heart conditions, or previous gene/cellular therapies can't join.
What is being tested?
The study tests bb2121—a CAR T-cell therapy—on people whose multiple myeloma has relapsed or is refractory. Patients will undergo a leukapheresis procedure to collect cells needed to create bb2121 which are then infused back after receiving drugs (fludarabine and cyclophosphamide) that prepare their immune system.
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever and chills; low blood cell counts leading to increased infection risk; fatigue; nausea; headaches; shortness of breath; potential allergic reactions to the drug components used during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You did not respond well to the last treatment you received.
Select...
You have been diagnosed with multiple myeloma and it is written in your medical records.
Select...
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.
Select...
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.
Select...
You must have already taken certain types of medications called proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody.
Select...
You are in good enough health to carry out your usual activities without limitations (ECOG performance status 0 or 1).
Select...
You must have recovered from any side effects of previous treatments, except for hair loss and mild nerve problems.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
You are currently taking medicine that weakens your immune system.
Select...
You have myeloma that has spread to your central nervous system.
Select...
You have a history of important brain or spinal cord problems.
Select...
You have had a stem cell transplant or gene therapy for cancer in the past.
Select...
You currently have or have had plasma cell leukemia.
Select...
You have a type of plasma cell cancer that is not easily measurable.
Select...
Your organs don't work well enough.
Select...
You have had serious heart problems like severe heart failure, stroke, heart attack, or dangerous heart rhythm issues in the past 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ minimum of 24 months post-bb2121 infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum of 24 months post-bb2121 infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate (ORR)
Secondary study objectives
Adverse Events (AEs)
Complete Response (CR) Rate
Duration of Response
+12 moreAwards & 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: Administration of bb2121Experimental Treatment1 Intervention
bb2121 autologous CAR T cells will be infused at a dose ranging from 15 - 450 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bb2121
2017
Completed Phase 2
~230
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
645 Previous Clinical Trials
130,291 Total Patients Enrolled
145 Trials studying Multiple Myeloma
41,654 Patients Enrolled for Multiple Myeloma
Kristen HegeStudy DirectorCelgene
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Multiple Myeloma
50 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,565 Previous Clinical Trials
3,383,846 Total Patients Enrolled
76 Trials studying Multiple Myeloma
28,955 Patients Enrolled for Multiple Myeloma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Administration of bb2121
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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