This study is NOT currently recruiting participants.
Number
19-C-0046
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: No longer recruiting/follow-up only Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
Yes
Population Exclusion(s)
Children
Keywords
Peripheral Blood Cells; Multiple Myeloma; Lentiviral Vector; Human BCMA; Natural History
Recruitment Keyword(s)
None
Condition(s)
Myeloma, Plasma-Cell; Myeloma-Multiple
Investigational Drug(s)
Anti-BCMA CAR+ T cells
Investigational Device(s)
Intervention(s)
Supporting Site
National Cancer Institute
Gene therapy is one kind of treatment for disease. Researchers have experience with gene therapy over the past decade, but they want to learn more about long-term effects. They want to study people who were previously treated with a gene-modified (GM) T cell therapy. Their T cells were collected and changed. New genes were put into the T cells to help those cells identify and kill specific cancer cells. Researchers want to monitor the long-term health of people who had this therapy.
Objective:
To continuously monitor the health and quality of life of people who had GM T cell therapy.
Eligibility:
People enrolled in study GC-LTFU-001 who were over 18 years old when they had the GM T cell therapy
Design:
Participants will be screened with a review of their medicines and medical history.
Participants will be in the study for 15 years after their last GM T cell infusion.
Participants will have three visits in year 1. They will have two visits a year in years 2 5. Then they will have one visit a year in years 6 15.
Visits will include some or all of the following:
Medical history
Physical exam
Questions about quality of life and cancer treatment
Blood tests
Tumor samples
Researchers may contact participants doctors during the study.
Participants will be asked to inform study staff if they develop certain conditions.
Participants will be asked to give permission for researchers to get a tissue sample if the participant dies during the study period.
Sponsoring Institute: National Cancer Institute
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INCLUSION CRITERIA: Subjects who meet the following criteria will be eligible to participate in the LTFU study: -All adult and pediatric subjects who received at least one GM T cell infusion in a previous Celgene-sponsored or Celgene alliance partner sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable. -Subject (and, parental/legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form (ICF/)/Informed Assent Form (IAF) prior to any study-related assessments/procedures being conducted. -Not applicable per Protocol Amendment 01: Subject is willing and able to adhere to the study visit schedule and other protocol requirements. EXCLUSION CRITERIA Not Applicable.
Subjects who meet the following criteria will be eligible to participate in the LTFU study:
-All adult and pediatric subjects who received at least one GM T cell infusion in a previous Celgene-sponsored or Celgene alliance partner sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
-Subject (and, parental/legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form (ICF/)/Informed Assent Form (IAF) prior to any study-related assessments/procedures being conducted.
-Not applicable per Protocol Amendment 01: Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
EXCLUSION CRITERIA
Not Applicable.
Principal Investigator
Referral Contact
For more information: