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OpenTrials
Completed

NCT Number: NCT01410981

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Genentech, Inc.

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 5, 2011
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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