Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates
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|ClinicalTrials.gov Identifier: NCT00577642|
Recruitment Status : Completed
First Posted : December 20, 2007
Results First Posted : March 10, 2017
Last Update Posted : March 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Zoledronic acid||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Bone Marker Assessment of Multiple Myeloma Patients Treated With AminoBisphosphonates|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
U.S. FDA Resources
Single arm biomarker study after a single dose of zoledronic acid
Drug: Zoledronic acid
4mg IV over at least 15 minutes or corrected for creatinine clearance x 1
Other Name: Zometa
- Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr [ Time Frame: 6 months ]Number of participants with urinary NTX levels less than or equal to 50 nmol/mmol creatinine (Cr) for the duration of study followup, following a single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1). Dose administration was followed by Aminobisphosphonates (aBP) treatment cessation during study period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577642
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Noopur Raje, MD||Massachusetts General Hospital|