Role of Osteocytes in Myeloma Bone Disease

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Simon Cancer Center, Indianapolis, Indiana, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Attaya Suvannasankha

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2022
Study completion: 2022
First posted: Aug 8, 2014
Registry last updated: Sep 8, 2023

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

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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.

Published trials that share one or more normalized conditions with this study.

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