Autophagy Induction After Bortezomib for Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01594242|
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: 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|
|Intervention Model Description:||Patients who are planned to start a bortezomib-containing regimen (whether for newly diagnosed or relapsed myeloma) will begin with one week off therapy and then one week of single agent bortezomib to allow investigation of its effects on cellular metabolism. Patients may then go on to receive bortezomib in whatever combination is planned by their treating oncologist.|
|Masking:||None (Open Label)|
|Official Title:||A Phase 0 Study of Autophagy Induction After Bortezomib For Myeloma|
|Actual Study Start Date :||July 10, 2012|
|Actual Primary Completion Date :||March 2, 2015|
|Actual Study Completion Date :||March 2, 2015|
Experimental: Autophagy Induction After Bortezomib
Subjects will undergo a baseline bone marrow aspirate and biopsy (under sedation if preferred by the subject) and have baseline blood samples (and urine samples if clinically indicated for measurement of their myeloma).
The following week, subjects will undergo a second bone marrow aspirate and biopsy and have additional blood samples taken for research assays prior to starting therapy on treatment day 1 with bortezomib at the standard dose of 1.3 mg/m2. Subjects will receive a second dose of bortezomib on treatment day 4, followed by a third bone marrow aspirate and biopsy on treatment day 4 or 5, along with serial blood samples on treatment days 4 and 5. After completion of the week of study treatment, subjects may continue treatment with the bortezomib-containing regimen planned by their treating oncologist. Active study participation will end after the completion of the week of study treatment.
- 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|