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Spots Global Cancer Trial Database for Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

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Trial Identification

Brief Title: Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

Official Title: A Phase II Study of Bone Marker Assessment of Multiple Myeloma Patients Treated With AminoBisphosphonates

Study ID: NCT00577642

Interventions

Zoledronic acid

Study Description

Brief Summary: The purpose of this research study is to define the time a molecule in the participants bones called NTX begins to rise after receiving treatment with bisphosphonates. NTX is measured in the urine to determine the rate of bone breakdown. Tracking this marker may help identify a more optimal dosing schedule of bisphosphonate therapy. Bisphosphonate drugs like zoledronic acid, which will be used in this study, are used to reduce pain and bone fractures in people with multiple myeloma. There is some laboratory data to suggest that they may work against myeloma. Participants will have already undergone bisphosphonate therapy and may have received zoledronic acid as treatment. Typically these agents are continued indefinitely. Due to concerns of their long-term side effects we are looking at alternate strategies for reducing the frequency of these agents.

Detailed Description: * Each participant will receive a single dose of zoledronic acid intravenously after the screening procedures. * Participants will then return to the clinic once every month for 6 months and have the following tests and procedures performed: Medical history update; physical exam; ECOG (Eastern Cooperative Oncology Group) Performance Status; blood tests; and urine tests. * After 6 months there will be an end of study visit, where the following procedures will take place: medical history update; bone marrow aspirate and biopsy; skeletal survey.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Massachusetts General Hospital, Boston, Massachusetts, United States

Contact Details

Name: Noopur Raje, MD

Affiliation: Massachusetts General Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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