A Diagnostic Screening Trial Seeking AL Amyloidosis Very Early (SAVE)
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|ClinicalTrials.gov Identifier: NCT02741999|
Recruitment Status : Recruiting
First Posted : April 18, 2016
Last Update Posted : September 21, 2017
|Condition or disease|
|Plasma Cell Dyscrasia Monoclonal Gammopathy|
In this trial up to 200 patients with either λ light chain (LC) monoclonal gammopathy of undetermined significance (MGUS) or λ LC smoldering multiple myeloma (SMM) with a κ::λ LC ratio < 0.26 and whose λ minus κ LC difference (dFLC) is greater than 23 mg/L will be recruited. Heavy chain type will not affect patient eligibility as long as the involved LC is λ type.
Patients may learn about the trial through internet advertisements and contact the data manager to receive the study's enrollment documents. Patient recruitment will be open to all eligible patient within the United States. Informed consent may be obtained in person or by phone. After the patient has completed a HIPPA release form, the patient's physician will be contacted and informed of the patient's consent to this study and will be asked to provide medical records for screening. If the patient is found eligible, the patient and physician will be informed of the required samples for the protocol, which include peripheral blood and marrow aspirate, if available, with both taken during routine clinical procedures. Prepaid FedEx boxes will be provided by the study to ship research samples to Tufts Medical Center for remote patients.
Both the peripheral blood and marrow samples will be tested for the presence of variable region (VL) germline genes in our Tufts Medical Center laboratory. In addition, plasma isolated from the peripheral blood sample (as well as the corresponding identified germline gene) will be sent to the laboratory of Dr. Jonathan Wall at the University of Tennessee for assay analysis. The assay will seek to distinguish the presence of amyloidogenic vs. non-amyloidogenic light chains. Germline gene results from Tufts Medical Center will be shared with patients and their physicians; however, University of Tennessee assay analysis will not be shared due to its experimental nature.
The analysis of this trial will be based on the frequency with which enrolled MGUS and SMM patients are found to have genes associated with light chain amyloidosis (AL), are found to have asymptomatic AL or symptomatic AL, or progress to AL. The diagnosis of AL is a tissue diagnosis. If amyloidosis is suspected at any time during a subject's participation, their physician will be contacted and given recommendations regarding diagnostic tests and disease staging.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||A Diagnostic Screening Trial Seeking AL Amyloidosis Very Early|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
- Observation of disease progression in participants with AL-associated VL germline genes [ Time Frame: 5 years ]After sequencing of their light chain (LC) variable region (VL) germline gene, subjects with light chain amyloidosis (AL) associated sequences will be followed for up to 5 years to monitor the potential progression of their disease to AL amyloidosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741999
|Contact: Raymond Comenzo, MDemail@example.com|
|Contact: Melissa Warner, BSfirstname.lastname@example.org|
|United States, Massachusetts|
|Tufts Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02111|
|Contact: Melissa T Warner, BS 617-636-5907 email@example.com|
|Contact: Denis Toskic, BS 617-636-5907 firstname.lastname@example.org|
|Principal Investigator:||Raymond Comenzo, MD||Tufts Medical Center|