Manufacturing Outcomes with Patient Factors from Multiple Myeloma Patients Prescribed Ciltacabtagene Autoleucel
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 24-004965
Sponsor Protocol Number: JNJ-68284528
About this study
The purpose of this study is to identify patient factors that are associated with low-viability or low-dose out-of specification (OOS) in ciltacabtagene autoleucel drug product (DP).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- patients, aged ≥18 years
- must have a confirmed diagnosis of MM and have been prescribed treatment with commercially available ciltacabtagene autoleucel, as part of standard medical care, for the on-label treatment of MM after 28 February 2022
- must sign a participation agreement/ICF to allow use of their apheresis and DP samples and data collectio
Exclusion Criteria:
- any condition for which, in the opinion of the participating physician, participation would not be in the best interest of the patient
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 5/6/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Yi Lin, M.D., Ph.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available