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

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.

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