A Study of Chemotherapy in Patients with Immunoglobulin Light (or Heavy) Chain Amyloidosis
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: 12-003917
Sponsor Protocol Number: 12-003917
About this study
The aims of this prospective observational study will be to include all patients with systemic AL amyloidosis regardless of age or disease severity, in order to convey a ‘real-world’ picture of the disease, its response to myeloma-type chemotherapy regimens, associated toxicity and outcomes in terms of amyloidotic organ function, quality of life (QoL) and survival.
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:
- Group 1:
- Patients with high-risk cardiac amyloid as defined as:
- Troponin T greater than or equal to 0.035 ng/ml and NT-proBNP greater than or equal to 332 pg/ml.
- Group 2:
- Patients who have undergone high-dose chemotherapy with peripheral blood stem cell transplantation who have not achieved at least a very good partial response.
- Group 3:
- Any patient starting non-protocol therapy and willing to be followed for toxicity and QOL.
Exclusion Criteria:
- Unwillingness to participate or inclusion on a prospective treatment trial.
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Angela Dispenzieri, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available