Manufacturing Outcomes with Patient Factors from Multiple Myeloma Patients Prescribed Ciltacabtagene Autoleucel

Overview

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