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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Medical University of South Carolina
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Yubin Kang, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01410981
First received: July 13, 2011
Last updated: April 24, 2013
Last verified: April 2013
  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

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Study Population

There will be three different population of patients: 1) newly diagnosed, 2) relapsed, 3) refractory multiple myeloma

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410981

Contacts
Contact: Shanta Salzer 843-792-1463 salzers@musc.edu
Contact: Yubin Kang, MD 843-792-6520 kangy@musc.edu

Locations
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         
Sponsors and Collaborators
Medical University of South Carolina
Genentech
  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 October 02, 2014