Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01958528 |
| Other study ID # |
UPCC 28412 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 23, 2013 |
| Est. completion date |
January 22, 2019 |
Study information
| Verified date |
May 2022 |
| Source |
Abramson Cancer Center of the University of Pennsylvania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
