Prognostic Potential of Cell Surface Markers and Pim Kinases in Multiple Myeloma
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Purpose
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.
| Condition |
|---|
|
Multiple Myeloma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prognostic Potential of Cell Surface Markers and Pim Kinases in Multiple Myeloma |
- Measure the expression levels of CXCR4, CD47, and pS6 by flow cytometry in myeloma patient's marrow aspirate [ Time Frame: 3 years ] [ Designated as safety issue: No ]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
- Determine if Pim kinase inhibitors or sphingosine kinase 2 inhibitors will inhibit patients' myeloma cells [ Time Frame: 3 years ] [ Designated as safety issue: No ]Our aim 2 involves only in vitro cell culture system and in vivo animal models. We will measure the efficacy of Pim kinase inhibitors in inhibiting patients' myeloma cell growth in vitro using cell culture system. We will also determine the efficacy of Pim kinase inhibitors and sphingosine kinase 2 inhibitors in inhibiting tumor growth of patients' myeloma cells in animal models. We will measure the tumor size in animal models. Our Aim 2 does not involve any measurement of human myeloma patients. Therefore, measures of safety, tolerability etc in patients are not applicable.
Biospecimen Retention: Samples With DNA
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.
| Estimated Enrollment: | 130 |
| Study Start Date: | July 2011 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Multiple Myeloma subjects with bone marrow aspirate/biopsy
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
There will be three different population of patients: 1) newly diagnosed, 2) relapsed, 3) refractory multiple myeloma
Inclusion Criteria:
- A diagnosis of multiple myeloma or possible multiple myeloma who will have a bone marrow biopsy and aspirate
- Planned therapy with standard chemotreatment for multiple myeloma
- Laboratory data such as calcium, beta 2-microglobulin, albumin, creatinine and bone survey available for staging purpose.
- ≥18 years old
Exclusion Criteria:
- < 18 years old
- Patients who will not receive chemotreatment
- Patients whose treatment records are not available
Contacts and Locations| Contact: Shanta Salzer | 843-792-1463 | salzers@musc.edu |
| Contact: Yubin Kang, MD | 843-792-6520 | kangy@musc.edu |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Shanta Salzer 843-792-1463 salzers@musc.edu | |
| Contact: Yubin Kang, MD 843-792-6520 kangy@musc.edu | |
| Principal Investigator: Yubin Kang, MD | |
More Information
No publications provided
| Responsible Party: | Yubin Kang, Assistant Professor, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT01410981 History of Changes |
| Other Study ID Numbers: | 101565 |
| Study First Received: | July 13, 2011 |
| Last Updated: | April 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013