Trials / Completed
CompletedNCT02716103
Assessment of Minimal Residual Disease (MRD) After Antineoplastic Treatment in Patients With AL Amyloidosis
Assessment of Minimal Residual Disease (MRD) After Antineoplastic Treatment (Which May Include High Dose Melphalan and Autologous Stem Cell Transplantation (HDM/SCT)) in Patients With AL Amyloidosis: Feasibility and Prognostic Significance
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 45 (actual)
- Sponsor
- Boston Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | blood collection | |
| OTHER | bone marrow collection |
Timeline
- Start date
- 2016-11-21
- Primary completion
- 2020-09-04
- Completion
- 2020-09-04
- First posted
- 2016-03-23
- Last updated
- 2021-09-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02716103. Inclusion in this directory is not an endorsement.