A Prospective Study Of Circulating Multiple Myeloma Cells As A Biomarker Of Progression In Myeloma Precursor States (MGUS And SMM)
Conditions
a Diagnosis of MGUS or SMM by IMWG Criteria
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age 18 years of age or older

- Capable of informed consent

- A monoclonal gammopathy detected in the serum (i.e. intact monoclonal immunoglobulin IgG, IgA, IgM or biclonal).

- 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 secodnary 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.

- Light chain only monoclonal gammopathy.

- Inability to comply with follow-up.
Location
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Brendan Weiss, MD - 855-216-0098 - PennCancerTrials@emergingmed.com
Start Date
October 2013
Completion Date
October 2017
Sponsors
Abramson Cancer Center of the University of Pennsylvania
Source
Abramson Cancer Center of the University of Pennsylvania
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page