Role of Osteocytes in Myeloma Bone Disease

NCT02212262 | Completed DMC

• 1 other identifier: IUCRO-0498
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Molecular interactions between multiple myeloma and osteocytes

  To determine FGF23 and heparanase, Dkk1 and plasma klotho levels increase in patients with newly diagnosed and relapsed myeloma compared to healthy controls.

  Up to 4 years

Secondary Outcomes (2)

• Multiple Myeloma osteocytes and tumor staging

  Up to 4 years

• Multiple Myeloma osteocytes and Type I collagen fragments on bone resorption

  Up to 4 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Oncology Clinics at Indiana University Roudebuch VA Medical Center Community sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Attaya Suvannasankha: lead

Study Sites (2)

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

VA Roudebush Medical Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Officials

• Attaya Suvannasankha, M.D.

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 8, 2014
• Study Start: October 7, 2014
• Primary Completion: February 5, 2022
• Study Completion: February 5, 2022
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

US (2)