Longterm Follow-up of Subjects Treated With bb2121

Multiple Myeloma Clinical Trial

Official title:

Longterm Follow-up of Subjects Treated With bb2121

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02786511
• Other study ID #: LTF-305
• Status: Completed
• Start date: April 28, 2016
• Est. completion date: October 11, 2019

Study information

• Verified date: January 2020
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 11, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		15 years post-drug product infusion
Primary	Monitoring for all Adverse Events, including Serious Adverse Events, related to the drug product		15 years post-drug product infusion
Primary	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
Primary	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
Primary	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
Primary	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