NCT01958528

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• a Diagnosis of MGUS or SMM by IMWG Criteria

Timeline

• Start date: 2013-05-23
• Primary completion: 2019-01-11
• Completion: 2019-01-22
• First posted: 2013-10-09
• Last updated: 2022-05-20

Locations

1 site across 1 country: United States