Relapsed or High-Risk Myeloma Receiving Novel Immunotherapies Outcomes of Patients

Overview

About this study

The purpose of this study is to utilize this global immunotherapy database to assess regional/geographic differences in treatment selection, toxicity and outcomes following novel
immunotherapy and to assess selection differences, treatment sequencing and outcomes from salvage therapy after first or subsequent novel immunotherapy.

 

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:

  • Histologically confirmed diagnosis of multiple myeloma.
  • Previous exposure to at least one PI, one IMiD and a CD38 antibody or has evidence of High-risk multiple myeloma (Defined as R-ISS III, relapsed or progressive disease within 12 months of initiating therapy, or presence of HR fish/genetics (Appendix III)). AND
    • Patient has received or will soon receive treatment with a novel immunotherapy.
  • Eligible immunotherapies include:
    • BCMA targeted cellular therapy including chimeric antigen receptor Tcells (CAR T-cells).;
    • BCMA targeted antibody-drug conjugate therapy (ADC);
    • BCMA targeted immune cell engaging antibody (IEA);
    • Novel target (i.e. GPRC5D) directed CAR T-cell or other cellular therapy, ADC or IEA therapy;
    • Complete diagnostic and myeloma treatment data, pre-treatment variables and immunotherapy treatment details should be available (or be expected to be available) including safety, response and outcome assessments.
  • Eligibility for control patients – is similar to immunotherapy subjects except that these patients have not received a novel immunotherapy.
    • At least three prior lines of therapy including a PI, IMiD and CD38 antibody;
    • Eligible to receive a novel immunotherapy but received other standard of care. therapy and data available to assess toxicity and response.
  • Eligibility for VTB patients – is identical to the immunotherapy database eligibility but these subjects will have donated tissue samples as part of a separate local tissue-bank approved protocol, and patients must elect to allow the use of their data.
  • Signed informed consent and access to the patient’s medical record is required.

Exclusion Criteria: 

  • Any condition that, per investigator, would limit the ability for prospective chart review and data capture.
  • Receipt of an immunotherapeutic regimen in a clinical trial that prohibits data sharing.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/2/2022. 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
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CLS-20589213

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