An observational study in a Diagnosis of MGUS or SMM by IMWG Criteria, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-20.
Sponsored by Abramson Cancer Center at Penn Medicine · Observational
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.
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 52 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male and Female subjects with diagnosis of MGUS or SMM by IMWG Criteria
Absence of myeloma related organ or tissue impairment ("CRAB") as defined by:
Exclusion Criteria:
Time to Progression
Time frame: 4 years
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Abramson Cancer Center at Penn Medicine