Study 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.
Eligible Conditions
- Multiple Myeloma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 15 Secondary · Reporting Duration: Minimum of 24 months post-bb2121 infusion
Month 24
Subject-reported outcomes as measured by EuroQoL Group EQ-5D-5L Health Questionnaire
Month 24
Adverse Events (AEs)
Complete Response (CR) Rate
Duration of Response
Immunogenicity
Neoplasm, Residual
Overall Response Rate (ORR)
Overall Survival (OS)
Pharmacokinetics - AUC
Pharmacokinetics - Cmax
Pharmacokinetics - Tmax
Progression-free Survival (PFS)
Subject-reported outcomes as measured by EORTC-QLQ-MY20
Subject-reported outcomes as measured by European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC-QLQ-C30)
Time to Progression (TTP)
Time to Response
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
Administration of bb2121
1 of 1
Experimental Treatment
149 Total Participants · 1 Treatment Group
Primary Treatment: bb2121 · No Placebo Group · Phase 2
Administration of bb2121
Biological
Experimental Group · 1 Intervention: bb2121 · Intervention Types: BiologicalTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Idecabtagene vicleucel
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: minimum of 24 months post-bb2121 infusion
Who is running the clinical trial?
CelgeneLead Sponsor
625 Previous Clinical Trials
173,021 Total Patients Enrolled
139 Trials studying Multiple Myeloma
39,171 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
1,407 Previous Clinical Trials
3,309,018 Total Patients Enrolled
62 Trials studying Multiple Myeloma
21,584 Patients Enrolled for Multiple Myeloma
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The subject is old enough to make an informed decision when they sign the form.
is rare
Rarely, a person is diagnosed with multiple myeloma.
Must have received at least 3 prior treatments with different chemotherapy drugs.
Must have undergone at least 2 consecutive cycles of treatment for each regimen, unless the patient's cancer was in remission or the best response to the regimen.
The individual must have received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
Must not have responded to the last treatment regimen.
A person's urine has M-protein levels that are greater than or equal to 200 milligrams per 24 hours.
A person with an ECOG performance status of 0 or 1 is able to carry out all usual activities and has no symptoms.
A serum protein level greater than or equal to 1.0 g/dL is suggestive of monoclonal gammopathy.
A serum free light chain assay is considered positive if the involved FLC level is greater or equal to 10 mg/dL (100 mg/L) and the serum FLC ratio is abnormal.
References
- Munshi, Nikhil C., Larry D. Anderson Jr., Nina Shah, Deepu Madduri, Jesús Berdeja, Sagar Lonial, Noopur Raje, et al.. 2021. “Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2024850.
- Raje, Noopur, Jesus Berdeja, Yi Lin, David Siegel, Sundar Jagannath, Deepu Madduri, Michaela Liedtke, et al.. 2019. “Anti-bcma CAR T-cell Therapy Bb2121 in Relapsed or Refractory Multiple Myeloma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1817226.
- Da Vià, Matteo C., Oliver Dietrich, Marietta Truger, Panagiota Arampatzi, Johannes Duell, Anke Heidemeier, Xiang Zhou, et al.. 2021. “Homozygous BCMA Gene Deletion in Response to Anti-bcma CAR T Cells in a Patient with Multiple Myeloma”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-021-01245-5.
- Delforge, Michel, Nina Shah, Jesús San F. Miguel, Julia Braverman, Devender S. Dhanda, Ling Shi, Shien Guo, et al.. 2022. “Health-related Quality of Life with Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2021005913.
- Sharma, Poornima, Bindu Kanapuru, Bindu George, Xue Lin, Zhenzhen Xu, Wilson W. Bryan, Richard Pazdur, and Marc R. Theoret. 2022. “FDA Approval Summary: Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-3803.
- Shah N, Mojebi A, Ayers D, Cope S, Dhanasiri S, Davies FE, Hari P, Patel P, Hege K, Dhanda D. Indirect treatment comparison of idecabtagene vicleucel versus conventional care in triple-class exposed multiple myeloma. J Comp Eff Res. 2022 Jul;11(10):737-749. doi: 10.2217/cer-2022-0045. Epub 2022 Apr 29.
- Da Via MC, Dietrich O, Truger M, Arampatzi P, Duell J, Heidemeier A, Zhou X, Danhof S, Kraus S, Chatterjee M, Meggendorfer M, Twardziok S, Goebeler ME, Topp MS, Hudecek M, Prommersberger S, Hege K, Kaiser S, Fuhr V, Weinhold N, Rosenwald A, Erhard F, Haferlach C, Einsele H, Kortum KM, Saliba AE, Rasche L. Homozygous BCMA gene deletion in response to anti-BCMA CAR T cells in a patient with multiple myeloma. Nat Med. 2021 Apr;27(4):616-619. doi: 10.1038/s41591-021-01245-5. Epub 2021 Feb 22.
- 2017. "Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03361748.
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Conditions
Cancer Related
Treatments