Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Bone Marker Assessment of Multiple Myeloma Patients Treated With AminoBisphosphonates|
- To assess the proportion of patients with urinary NTX levels less than or equal to 50nmol/mmol following a single dose of zoledronic acid. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Gather baseline information on markers of disease activity, bone turnover, bone remodeling, and osteoclast activating factors in this patient population. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Drug: Zoledronic acid
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577642
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Noopur Raje, MD||Massachusetts General Hospital|