Longterm Follow-up of Subjects Treated With bb2121



Status:Enrolling by invitation
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:April 28, 2016
End Date:April 28, 2035

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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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
9
sites
Bethesda, Maryland
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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Palo Alto, California 94304
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Palo Alto, CA
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Rochester, MN
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