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Role of Osteocytes in Myeloma Bone Disease

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ClinicalTrials.gov Identifier: NCT02212262
Recruitment Status : Recruiting
First Posted : August 8, 2014
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Attaya Suvannasankha, Indiana University School of Medicine

Study Description
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Brief Summary:

Progress in the treatment of myeloma and myeloma bone disease has substantially increased overall survival, but relapse is inevitable and better treatment is needed. The bone microenvironment is tremendously complex, so that targeting single interactions between tumor and bone is unlikely to be effective. Treatments need to block centrally important, multifunctional pathways. The investigators data point to a central role of the osteocyte to induce heparanase, a multifunctional mediator of myeloma bone disease. Increased heparanase due to FGF23 may make systemic inhibitors of heparanase less effective in bone than elsewhere. FGF23 neutralizing antibodies have been developed for non-cancer conditions of FGF23 excess, such as chronic kidney disease (Shimada & Fukamoto, 2012), and could be used in MM alone or in combination with heparanase inhibitors. Complete neutralization of FGF23 has adverse effects, but neutralization of FGF23 excess may be practical, or in the future, suppression of excess FGF23 biosynthesis by osteocytes.

The investigators hope to determine serum FGF23 and heparanase, Dkk1 and plasma klotho levels in patients with newly diagnosed and relapsed myeloma compared to healthy controls with this exploratory study.


Condition or disease
Multiple Myeloma

Study Design
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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Role of Osteocytes in Myeloma Bone Disease
Actual Study Start Date : July 23, 2014
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Multiple Myeloma Patients
Patients with multiple myeloma will undergo a blood draw and a bone marrow aspirate. Extra bone marrow will be taken for study purposes only.
Healthy subjects
Healthy subjects and multiple myeloma patients will undergo a blood draw


Outcome Measures
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Primary Outcome Measures :
  1. Molecular interactions between multiple myeloma and osteocytes [ Time Frame: Up to 4 years ]
    To determine FGF23 and heparanase, Dkk1 and plasma klotho levels increase in patients with newly diagnosed and relapsed myeloma compared to healthy controls.


Secondary Outcome Measures :
  1. Multiple Myeloma osteocytes and tumor staging [ Time Frame: Up to 4 years ]
    To correlate the FGF23, heparanase, Dkk1 and plasma klotho to tumor staging

  2. Multiple Myeloma osteocytes and Type I collagen fragments on bone resorption [ Time Frame: Up to 4 years ]
    To correlate the FGF23, heparanase, Dkk1 and plasma klotho to extent of bone resorption using serum type I collagen fragments ICTP and CTX


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Oncology Clinics at Indiana University Roudebuch VA Medical Center Community sample
Criteria

Inclusion Criteria:

  1. Age > 18 years but ≤ 95 years at the time of consent
  2. Subjects must be English-speaking
  3. Must voluntarily sign the most current informed consent and HIPAA documents prior to study participation.
  4. Have no prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers can also be enrolled as healthy volunteers.
  5. Have no known liver or kidney disorders

Exclusion Criteria:

  1. Pregnant females will be excluded from the study.
  2. Subjects allergic to xylocaine will be excluded.
  3. Subjects with an acute illness (Ex. upper respiratory infection, viral illness) in the past seven days will be excluded.
  4. History of bleeding disorders.
  5. Subjects deemed incompetent by treating physician
  6. Institutionalized, mentally disabled subjects
  7. Subjects who are prisoners
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212262


Contacts
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Contact: Attaya Suvannasankha, M.D. 317-278-9306 asuvanna@iu.edu

Locations
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United States, Indiana
Indiana University Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Attaya Suvannasankha, M.D.    317-278-9306    asuvanna@iu.edu   
Principal Investigator: Attaya Suvannasankha, M.D.         
VA Roudebush Medical Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Attaya Suvannasankha, M.D.    317-278-9306    asuvanna@iu.edu   
Principal Investigator: Attaya Suvannasankha, M.D.         
Sponsors and Collaborators
Attaya Suvannasankha
Investigators
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Principal Investigator: Attaya Suvannasankha, M.D. Indiana University
More Information
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Responsible Party: Attaya Suvannasankha, Assistant Professor of Clinical Medicine, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT02212262     History of Changes
Other Study ID Numbers: IUCRO-0498
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Bone Diseases
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
Musculoskeletal Diseases