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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with multiple myeloma | Subjects treated with ex vivo gene therapy in a bluebird bio sponsored trial who agree to participate in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safety and efficacy assessments | Drug | Vector copy number (VCN) measurement, safety evaluations, disease-specific assessments, and assessments to monitor for long-term implications of autologous transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 15 years post-drug product infusion | |
| Monitoring for all Adverse Events, including Serious Adverse Events, related to the drug product | 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 | 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. | 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. | 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. | 5-15 years post-drug product infusion |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with multiple myeloma who were administered bb2121 in Study CRB-401
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Hege | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Palo Alto | California | 94305 | United States | ||
| National Cancer Institute |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D012449 | Safety |
| ID | Term |
|---|---|
| D000056 | Accident Prevention |
| D000059 | Accidents |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Bethesda |
| Maryland |
| 20892 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02144 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |