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Minimal Residual Disease as a Possible Predictive Factor for Relapse in Patients With AL Amyloidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02555969
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : August 24, 2020
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:
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.

Condition or disease
Amyloidosis Primary Amyloidosis

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Minimal Residual Disease as a Possible Predictive Factor for Relapse in Patients With AL Amyloidosis
Study Start Date : August 2015
Actual Primary Completion Date : August 2020
Actual Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Primary Outcome Measures :
  1. Minimal Residual Disease Testing by Q-PCR, NGS, and mass spectrometry [ Time Frame: 3 years ]
    After achievement of a CR or VGPR, minimal residual disease testing (using Q-PCR, WGS, and plasma protein analysis by mass spectrometry) will be done annually for up to 3 years. These tests will show either the presence of absence of minimal residual disease. These findings will then be correlated with progression free survival as assessed through standard clinical tests for AL amyloidosis.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will enroll AL amyloidosis patients at Tufts Medical Center who have baseline bone marrow cells available from the time of diagnosis, or from a time of therapy prior to achieving a response, and then subsequently achieve a CR or VGPR with first-line therapy. Up to 50 patients diagnosed with AL amyloidosis will be evaluated on this protocol.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients who do not have available baseline bone marrow samples.

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 identifier (NCT number): NCT02555969

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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
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Principal Investigator: Raymond Comenzo, MD Tufts Medical Center

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Responsible Party: Tufts Medical Center Identifier: NCT02555969    
Other Study ID Numbers: 11829
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Neoplasm, Residual
Immunoglobulin Light-chain Amyloidosis
Pathologic Processes
Proteostasis Deficiencies
Metabolic Diseases
Neoplastic Processes
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases