Clinical Trial Details for Study "GCC 1001"

Official Title: Pharmacologic and Microbial Assessment of Saliva in Multiple Myeloma Patients at Risk for Bisphosphonate-Related Osteonecrosis of the Jaw

Investigator: Ashraf Badros, M.D.

Summary: This an observational specimen collection study to allow researchers at the University of Maryland Greenebaum Cancer Center to collect saliva and blood specimens for analysis in order to better understand the cause of this osteonecrosis of the jaw.

Disease site: Multiple Myeloma

Disease stage: Multiple myeloma

Condition: Bisphosphonate-Related Osteonecrosis of the Jaw (ONJ)

Intervention: Specimen Collection

Phase: Observational

Study number: GCC 1001

Eligibility*
(inclusion criteria)
    Patients must have confirmed multiple myeloma with or without history of active osteonecrosis of the jaw; Patients should be receiving bisphosphonate therapy; Patents will be age >18 years, as the disease is extremely rare in the pediatric population;Abnormal organ and marrow functions do not preclude enrollment on this observational study; Ability to understand and willingness to sign a written informed consent document.
(exclusion criteria)
    Patients may not be receiving any other investigational agents that specifically affect bone metabolism; MM therapy will be allowed; Pregnant women are not excluded from this study because there is no intervention that would have teratogenic or abortifacient effects. That said, all MM patients of child-bearing age are strongly advised to avoid becoming pregnant due to the nature of MM therapy.

Contact Person
Pat Lesho, RN 410-328-2577

* Note: This study may include eligibility criteria that are not listed here. For more information about the study or to find out if you are eligible, call 1-800-888-8823.


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