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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02716103
Other study ID # H-34469
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 21, 2016
Est. completion date September 4, 2020

Study information

Verified date September 2021
Source Boston Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In this study, the investigators seek to evaluate bone marrow and blood samples and treatment responses to see if Minimal Residual Disease (MRD) can be used as a predictive method of response to treatment in amyloidosis.


Description:

In this study, the investigators seek to evaluate bone marrow and blood samples and treatment responses to see if Minimal Residual Disease (MRD) (as described below), can be used as a predictive method of response to treatment in amyloidosis. Minimal residual disease (MRD) is a concept that has gained significant value as a prognostic predictor and has become an emerging constituent of complete response (CR) reassessment in multiple myeloma (MM) patients. Studies in MM have demonstrated that up to 30% of patients achieving a CR after high-dose therapy will still have detectable MRD in the bone marrow as measured by standard-sensitivity flow cytometry or by molecular assays. Virtually every study examining MRD in MM has reported that among patients achieving a CR, those who were MRD negative (MRD-) had a significantly superior progression-free survival, with some studies reporting superior overall survival. As amyloidosis is a disease that is very similar to multiple myeloma, the investigators wish to evaluate the concept in this disease.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date September 4, 2020
Est. primary completion date September 4, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Biopsy-proven systemic AL amyloidosis defined as - At least one + Congo Red stain - Proof of a clonal plasma cell dyscrasia by: - Immunofixation electrophoresis (IFE) of the urine or serum - Light chain restriction based on Immunohistochemistry (IHC) in bone marrow plasma cells or in the amyloid tissue - Must be scheduled to undergo antineoplastic therapy (this may include high dose melphalan and Autologous Stem Cell Transplantation) for AL Amyloidosis (Part II enrollments only) Exclusion Criteria: - Co-existing Multiple Myeloma - Prior antineoplastic treatment for AL amyloidosis at time of enrollment. - Prior negative bone marrow biopsy showing no identifiable clone

Study Design


Related Conditions & MeSH terms


Intervention

Other:
blood collection

bone marrow collection


Locations

Country Name City State
United States Boston Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Isolation of a plasma cell clone Number of samples that have a successful isolation of a plasma cell clone 1 year
Secondary Minimal residual disease observed Number of cases in which minimal residual disease observed in specimens correlates 5 years
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