NCT01410981|CompletedDMC
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Sponsor study identifier
observational
73
1 country
1
Study Start
August 2011
Actual (reported)Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)The purpose of this study is to understand if small proteins found on the surface of myeloma cells (called CXCR4 and CD47) or inside the myeloma cells (Pim kinases, sphingolipids, and pS6) can predict how patients will respond to chemotherapy-treatment and if a small molecule inside the myeloma cells (called Pim kinase) can be used as a treatment target for myeloma. A sample from the bone marrow biopsy (a small amount of tissue removed from the body for laboratory testing) and aspirate (a small amount of fluid is removed from the body for laboratory testing) that had been done before the subject entered this study will be provided for research purposes. Based on preliminary data, it is hypothesized that CXCR4, CD47, sphingolipids, and Pim kinases could be used as prognostic/predictive markers and that Pim kinase inhibitors provide a new agent for the treatment of multiple myeloma.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 13, 2011
Actual (reported)August 2011
Actual (reported)August 5, 2011
Actual (reported)June 2014
Actual (reported)June 2014
Actual (reported)Measure the expression levels of CXCR4, CD47, and pS6 by flow cytometry in myeloma patient's marrow aspirate
Our Aim 1 is to perform a corrective study to measure the expression levels of CXCR4, CD47, and pS6 by flow cytometry in myeloma patient's marrow aspirate and correlate their expression level with patients' treatment responses
3 years
Determine if Pim kinase inhibitors or sphingosine kinase 2 inhibitors will inhibit patients' myeloma cells
3 years
All patients seen at MUSC with a diagnosis of multiple myeloma or possible multiple myeloma who undergo bone marrow aspirate and biopsy will be approached for participation in this study.
There will be three different population of patients: 1) newly diagnosed, 2) relapsed, 3) refractory multiple myeloma
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Sundaramoorthy P, Gasparetto C, Kang Y. The combination of a sphingosine kinase 2 inhibitor (ABC294640) and a Bcl-2 inhibitor (ABT-199) displays synergistic anti-myeloma effects in myeloma cells without a t(11;14) translocation. Cancer Med. 2018 Jul;7(7):3257-3268. doi: 10.1002/cam4.1543. Epub 2018 May 15.
Venkata JK, An N, Stuart R, Costa LJ, Cai H, Coker W, Song JH, Gibbs K, Matson T, Garrett-Mayer E, Wan Z, Ogretmen B, Smith C, Kang Y. Inhibition of sphingosine kinase 2 downregulates the expression of c-Myc and Mcl-1 and induces apoptosis in multiple myeloma. Blood. 2014 Sep 18;124(12):1915-25. doi: 10.1182/blood-2014-03-559385.
The patients will not have bone marrow biopsy or aspirate solely for this study. When the patients undergo routine bone marrow aspirate and biopsy for the purpose of initial diagnosis, followup or restaging, they will be asked and consented for participation in the study. The patient will then be treated with standard chemotherapy including Bortezomib-based, Revlimid-based, Thalidomide-based chemoregimen. The bone marrow aspirate from patients who consent to be in the study will be stained for CXCR4, CD47, pS6, in addition to standard study flow cytometry panel for multiple myeloma. The staining and flow cytometry analysis will be performed at the Clinical Flow Cytometry Facility (Director: Dr. Sally Self) according to the standard flow cytometry procedure. Sphingolipid gene expression levels will be measured. A small aliquot may be sent to collaborators in Genentech Corp for measurement of pS6 and Pim kinase expression. The sample information will be de-identified.
Gustavo Leone
Medical University of South Carolina, Hollings Cancer Center
73 participants (actual enrollment reported by the registry).
First Submitted
July 13, 2011
First Posted
August 5, 2011
Study Start
August 2011
Actual (reported)Anti-CXCR4 (BMS-936564) Alone and in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma
Contact the study team to confirm eligibility.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
April 5, 2018
Record last verified: 2018-04
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