Assessment of Minimal Residual Disease (MRD) After Antineoplastic Treatment in Patients With AL Amyloidosis

Amyloidosis Clinical Trial

— MRD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716103
• Other study ID #: H-34469
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Amyloidosis
• Immunoglobulin Light-chain Amyloidosis
• Neoplasm, Residual

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