Prognostic Potential of Cell Surface Markers and Pim Kinases in Multiple Myeloma

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2014

Arms, Groups and 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.

Clinical Trial Outcome Measures

Primary Measures

  • Measure the expression levels of CXCR4, CD47, and pS6 by flow cytometry in myeloma patient’s marrow aspirate
    • Time Frame: 3 years
    • 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

Secondary Measures

  • Determine if Pim kinase inhibitors or sphingosine kinase 2 inhibitors will inhibit patients’ myeloma cells
    • Time Frame: 3 years
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of South Carolina
  • Collaborator
    • Genentech, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gustavo Leone, Study Chair, Medical University of South Carolina, Hollings Cancer Center

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