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

May 18, 2022 updated by: Abramson Cancer Center of the University of Pennsylvania

A Prospective Study Of Circulating Multiple Myeloma Cells As A Biomarker Of Progression In Myeloma Precursor States (MGUS And SMM)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of The University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and Female subjects with diagnosis of MGUS or SMM by IMWG Criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1 Progressors
Cohort 2 - Non-Progressors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Progression
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2013

Primary Completion (Actual)

January 11, 2019

Study Completion (Actual)

January 22, 2019

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (Estimate)

October 9, 2013

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 28412

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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