An observational study in Multiple Myeloma, sponsored by Celgene. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by Celgene · Observational
This is a multi-center, non-randomized, open label, longterm safety and efficacy follow-up study for subjects who have been treated with bb2121 in the Phase 1 clinical parent study, that evaluated the safety and efficacy of bb2121 in subjects with relapsed or refractory B cell maturation antigen (BCMA)-expressing multiple myeloma.
bb2121 is defined as autologous T lymphocytes (T cells) transduced ex vivo with anti-BCMA02 CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA suspended in cryopreservative solution. bb2121 is administered in subjects 1 time (or retreated if retreatment criteria are met) in parent clinical study. No investigational treatment will be administered in this study.
After completing the parent study, eligible subjects will be followed for up to 15 years after their last bb2121 infusion in the parent study.
The LTF-305 study has completed enrollment and is scheduled to be closed. All patients participating in this study have discontinued from follow-up or have been transferred into the GC-LTFU-001 study for further observation (similar to time frames established in the LTF-305).
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 50 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with multiple myeloma who were administered bb2121 in Study CRB-401
Exclusion Criteria:
Subjects treated with ex vivo gene therapy in a bluebird bio sponsored trial who agree to participate in this study.
Drug: Safety and efficacy assessments
Vector copy number (VCN) measurement, safety evaluations, disease-specific assessments, and assessments to monitor for long-term implications of autologous transplant
Overall survival
Time frame: 15 years post-drug product infusion
Monitoring for all Adverse Events, including Serious Adverse Events, related to the drug product
Time frame: 15 years post-drug product infusion
Monitoring for all Serious Adverse Events including any new malignancy or new diagnosis of a neurologic, rheumatologic, or hematologic disorder that is clinically significant
Time frame: 5 years post-drug product infusion
Monitoring for Multiple Myeloma-specific response according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma
Subjects without disease progression will be evaluated for at least 5 years post-drug product infusion if VCN is undetectable, and up to 15 years post-drug product infusion if VCN remains detectable.
Time frame: 5-15 years post-drug product infusion
Progression Free Survival
Subjects without disease progression will be evaluated for at least 5 years post-drug product infusion if VCN is undetectable, and up to 15 years post-drug product infusion if VCN remains detectable.
Time frame: 5-15 years post-drug product infusion
Monitoring for Vector Copy Number (VCN)
Subjects without disease progression will be evaluated for at least 5 years post-drug product infusion if VCN is undetectable, and up to 15 years post-drug product infusion if VCN remains detectable.
Time frame: 5-15 years post-drug product infusion
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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