Clinical trial NCT02212262: Role of Osteocytes in Myeloma Bone Disease
Official title: Role of Osteocytes in Myeloma Bone Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-08-08
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oncology Clinics at Indiana University Roudebuch VA Medical Center Community sample

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.


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

Primary outcomes:
measure: Molecular interactions between multiple myeloma and osteocytes
timeFrame: Up to 4 years
Secondary outcomes:
measure: Multiple Myeloma osteocytes and tumor staging
timeFrame: Up to 4 years
measure: Multiple Myeloma osteocytes and Type I collagen fragments on bone resorption
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: VA Roudebush Medical Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Attaya Suvannasankha, M.D.
role: PRINCIPAL_INVESTIGATOR
References: