Longterm Follow-up of Subjects Treated With bb2121

Completed

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT02786511

Run by

Celgene

People needed

50

Starts

2016-04-28

Expected to finish

2019-10-11

Last updated by the study team

2020-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of written informed consent for this study by subjects
• Were administered bb2121 in the parent clinical study
• Able to comply with the study requirements

You may not qualify if…

• Subject has disease progression AND subject has undetectable VCN (<0.0003 vector copies per diploid genome) in peripheral blood cells for 2 consecutive measurements at least 1 month apart, at least 12 months after drug product infusion

Where it is running

• Stanford Cancer Center — Palo Alto, California, United States
• National Cancer Institute — Bethesda, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Mount Sinai Medical Center — New York, New York, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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