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

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ClinicalTrials.gov Identifier: NCT02716103
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center

Brief 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.

Condition or disease Intervention/treatment
Amyloidosis Other: blood collection Other: bone marrow collection

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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
Actual Study Start Date : November 21, 2016
Actual Primary Completion Date : September 4, 2020
Actual Study Completion Date : September 4, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Group/Cohort Intervention/treatment
Initial Cohort: feasibility
Bone marrow collection and peripheral blood collection from ten patients with untreated AL amyloidosis will be evaluated to determine feasibility of isolating a plasma cell clone. An additional three teaspoons of bone marrow and 4 teaspoons of blood will be collected at the time of standard blood draw and bone marrow biopsy before receiving any treatment. There will be no extra procedures or visits specifically for this research.
Other: blood collection
Other: bone marrow collection
2nd Cohort - pre-treatment
If feasibility is determined with initial cohort, bone marrow collection and peripheral blood collection from 20 patients with untreated AL amyloidosis who are scheduled to undergo antineoplastic therapy will be evaluated to isolate a plasma cell clone. An additional 3 teaspoons of bone marrow and 4 teaspoons of blood will be collected at the time of standard blood draw and bone marrow biopsy before receiving therapy. For those who complete therapy and achieve complete response or very good partial response, subsequent samples of bone marrow and peripheral blood will be sent for minimal residual disease detection (based on the previously identified cancer clone) at 6 to 12 months post treatment.
Other: blood collection
Other: bone marrow collection



Primary Outcome Measures :
  1. Isolation of a plasma cell clone [ Time Frame: 1 year ]
    Number of samples that have a successful isolation of a plasma cell clone


Secondary Outcome Measures :
  1. Minimal residual disease observed [ Time Frame: 5 years ]
    Number of cases in which minimal residual disease observed in specimens correlates


Biospecimen Retention:   Samples With DNA
Bone marrow and peripheral blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with previously untreated AL amyloidosis
Criteria

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

Information from the National Library of Medicine

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): NCT02716103


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: Shayna Sarosiek, MD Boston Medical Center
Additional Information:

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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT02716103    
Other Study ID Numbers: H-34469
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Boston Medical Center:
AL amyloidosis, systemic primary amyloidosis
Additional relevant MeSH terms:
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Neoplasm, Residual
Immunoglobulin Light-chain Amyloidosis
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Paraproteinemias