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 : February 10, 2022
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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 |
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Multiple Myeloma |
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, 2023 |
Estimated Study Completion Date : | June 30, 2023 |

Group/Cohort |
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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.
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Healthy subjects
Healthy subjects and multiple myeloma patients will undergo a blood draw
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- 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.
- 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

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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 |
Inclusion Criteria:
- Age > 18 years but ≤ 95 years at the time of consent
- Subjects must be English-speaking
- Must voluntarily sign the most current informed consent and HIPAA documents prior to study participation.
- 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.
- Have no known liver or kidney disorders
Exclusion Criteria:
- Pregnant females will be excluded from the study.
- Subjects allergic to xylocaine will be excluded.
- Subjects with an acute illness (Ex. upper respiratory infection, viral illness) in the past seven days will be excluded.
- History of bleeding disorders.
- Subjects deemed incompetent by treating physician
- Institutionalized, mentally disabled subjects
- Subjects who are prisoners

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
Contact: Attaya Suvannasankha, M.D. | 317-278-9306 | asuvanna@iu.edu |
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. |
Principal Investigator: | Attaya Suvannasankha, M.D. | Indiana University |
Responsible Party: | Attaya Suvannasankha, Assistant Professor of Clinical Medicine, Indiana University School of Medicine |
ClinicalTrials.gov Identifier: | NCT02212262 |
Other Study ID Numbers: |
IUCRO-0498 |
First Posted: | August 8, 2014 Key Record Dates |
Last Update Posted: | February 10, 2022 |
Last Verified: | February 2022 |
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 |