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Longterm Follow-up of Subjects Treated With bb2121

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ClinicalTrials.gov Identifier: NCT02786511
Recruitment Status : Enrolling by invitation
First Posted : June 1, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

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.


Condition or disease Intervention/treatment
Multiple Myeloma Drug: Safety and efficacy assessments

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Longterm Follow-up of Subjects Treated With bb2121
Actual Study Start Date : April 28, 2016
Estimated Primary Completion Date : April 28, 2035
Estimated Study Completion Date : April 28, 2035

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort Intervention/treatment
Subjects with multiple myeloma
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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 15 years post-drug product infusion ]
  2. Monitoring for all Adverse Events, including Serious Adverse Events, related to the drug product [ Time Frame: 15 years post-drug product infusion ]
  3. 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 ]
  4. Monitoring for Multiple Myeloma-specific response according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma [ Time Frame: 5-15 years post-drug product infusion ]
    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. Progression Free Survival [ Time Frame: 5-15 years post-drug product infusion ]
    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.

  6. Monitoring for Vector Copy Number (VCN) [ Time Frame: 5-15 years post-drug product infusion ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with multiple myeloma who were administered bb2121 in Study CRB-401
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786511


Locations
United States, California
Stanford Cancer Center
Palo Alto, California, United States, 94305
United States, Maryland
National Cancer Institute
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02144
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Celgene
Investigators
Study Director: Kristen Hege Celgene Corporation

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02786511     History of Changes
Other Study ID Numbers: LTF-305
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases