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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

Tracking Information
First Submitted Date July 31, 2014
First Posted Date August 8, 2014
Last Update Posted Date October 18, 2018
Actual Study Start Date July 23, 2014
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02212262 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 7, 2014)
  • Multiple Myeloma osteocytes and tumor staging [ Time Frame: Up to 4 years ]
    To correlate the FGF23, heparanase, Dkk1 and plasma klotho to tumor staging
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of Osteocytes in Myeloma Bone Disease
Official Title Role of Osteocytes in Myeloma Bone Disease
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Oncology Clinics at Indiana University Roudebuch VA Medical Center Community sample
Condition Multiple Myeloma
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 7, 2014)
240
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Attaya Suvannasankha, M.D. 317-278-9306 asuvanna@iu.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02212262
Other Study ID Numbers IUCRO-0498
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Attaya Suvannasankha, Indiana University School of Medicine
Study Sponsor Attaya Suvannasankha
Collaborators Not Provided
Investigators
Principal Investigator: Attaya Suvannasankha, M.D. Indiana University
PRS Account Indiana University
Verification Date October 2018