Autophagy Induction After Bortezomib for Myeloma
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|ClinicalTrials.gov Identifier: NCT01594242|
Recruitment Status : Active, not recruiting
First Posted : May 9, 2012
Last Update Posted : September 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Other: Bortezomib||Early Phase 1|
The primary objective of this study is to determine whether administration of bortezomib leads to an increase in cellular autophagy, as determined by electron micrographs of peripheral blood lymphocytes and primary myeloma cells in patients receiving single-agent bortezomib.
- To determine the optimal timing of autophagy assessments for patients receiving bortezomib.
- To explore whether high levels of autophagy are associated with resistance to bortezomib therapy.
- To validate our primary assay by confirming baseline stability of the number of autophagic vesicles per cell
- To compare results of autophagy measurements in peripheral blood mononuclear cells and bone marrow plasma cells
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Phase 0 Study of Autophagy Induction After Bortezomib For Myeloma|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||June 2015|
- Number of Adverse Events [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594242
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Dan Vogl, MD||Abramson Cancer Center of the University of Pennsylvania|