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Study Of Circulating Multiple Myeloma Cells As A Biomarker of MGUS And SMM

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT01958528
Collaborator
(none)
52
Enrollment
1
Location
68
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective study to collect blood and bone marrow samples from patients with SM and MGUS. About 100 subjects will be enrolled at the University of Pennsylvania and followed for 2 years. The primary objective of this study is to evaluate CMMCs as a biomarker to detect patients at high risk of progression to multiple myeloma in patients with MGUS and SMM.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The primary objective is to evaluate CMMCs as a biomarker to detect patients at high risk of progression to multiple myeloma in patients with MGUS and SMM. The secondary objective are to correlate CMMCs with the Mayo Clinic prognostic models in MGUS/SMM, to compare bone marrow genomic findings with genomic findings in CMMC (utilizing multiple myeloma FISH panel), to perform immunophenotyping of bone marrow plasma cells, to perform gene expression profiling on CD138+bone marrow plasma cells and correlate with progression, to perform serum microRNA profiling and correlate with progression, to correlate bone marrow immunohistochemical studies evaluating the microenvironment with CMMC, to perform proteomic profiling on peripheral blood to evaluate serum biomarkers of progression and to establish a biorepository of samples of peripheral blood for future studies.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    52 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Study Of Circulating Multiple Myeloma Cells As A Biomarker Of Progression In Myeloma Precursor States (MGUS And SMM)
    Actual Study Start Date :
    May 23, 2013
    Actual Primary Completion Date :
    Jan 11, 2019
    Actual Study Completion Date :
    Jan 22, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort 1 Progressors
    Cohort 2 - Non-Progressors

    Outcome Measures

    Primary Outcome Measures

    1. Time to Progression [4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 18 or greater

    • Capable of informed consent

    • A monoclonal gammopathy detected in the serum, including intact immunoglobulin (IgG and IgA) and light chain only gammopathies. Light chain only gammopathy is defined as an abnormal light chain ratio and increased involved light chain).44, 45

    • Absence of myeloma related organ or tissue impairment ("CRAB") as defined by:

    • Hypercalcemia (calcium greater than or equal to 11)

    • Renal failure (creatinine >2.0)

    • Anemia hemoglobin <10 gm/dl)

    • Bone disease (Osteolytic lesions, fractures)

    Exclusion Criteria:

    • A secondary B-cell neoplasm or other active malignancy aside from non-melanoma skin cancer or localized prostate cancer. An active malignancy is any malignancy requiring therapy within the past 3 years. Patients with monoclonal B-cell lymphocytosis are not excluded.

    • IgM monoclonal gammopathy

    • Inability to comply with follow-up

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Abramson Cancer Center of the University of Pennsylvania

    Investigators

    • Principal Investigator: Alfred Garfall, MD, Abramson Cancer Center of the University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abramson Cancer Center of the University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT01958528
    Other Study ID Numbers:
    • UPCC 28412
    First Posted:
    Oct 9, 2013
    Last Update Posted:
    May 20, 2022
    Last Verified:
    May 1, 2022
    Additional relevant MeSH terms:
    Multiple Myeloma

    Study Results

    No Results Posted as of May 20, 2022