Minimal Residual Disease as a Possible Predictive Factor for Relapse in Patients With AL Amyloidosis
Completed
Conditions studied: Amyloidosis, Primary Amyloidosis
In brief
This protocol will assess patients with AL amyloidosis who achieve a complete response (CR) or very good partial response (VGPR) to therapy for minimal residual disease (MRD). Three approaches to MRD testing will be used since there is no established method. The investigators will clone and sequence each patient's light chain (LC) gene and design patient-specific primers to evaluate genomic DNA from future marrow specimens. Whole genome sequencing (WGS) will be used to test baseline and follow-up marrow cell DNA, seeking copy number variations in chromosomes 1 and 2 or 22, and structural variations in chromosomes 11 and 14, consistent with the known genetic abnormalities in AL and with clonal LC gene use. Plasma protein analysis by mass spectrometry will also be used to look for fragmentary protein sequences associated with the culprit LC gene of each subject. The feasibility and predictive value of these three approaches in patients achieving CR or VGPR will be evaluated. This protocol will help provide insight into the ways that the disease changes and progresses. MRD testing is likely an important next step in AL management.
Key facts
- Study ID
- NCT02555969
- Run by
- Tufts Medical Center
- People needed
- 56
- Starts
- 2015-08-01
- Expected to finish
- 2020-08-01
- Last updated by the study team
- 2020-08-24
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with AL amyloidosis at Tufts Medical Center who have baseline bone marrow samples available and achieve a CR or VGPR to treatment. Patients may consent and register at diagnosis and have a baseline marrow collected at the time of consent; or patients may consent during therapy prior to achieving a response, if they have previously banked marrow cells for research.
You may not qualify if…
- Patients who do not have available baseline bone marrow samples.
Where it is running
- Tufts Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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