Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Dana-Farber Cancer Institute
American Society of Clinical Oncology
Information provided by (Responsible Party):
Noopur Raje, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00577642
First received: December 18, 2007
Last updated: May 7, 2013
Last verified: May 2013

December 18, 2007
May 7, 2013
October 2007
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00577642 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates
A Phase II Study of 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.

  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: Zoledronic acid
4mg IV over at least 15 minutes or corrected for creatinine clearance x 1
Other Name: Zometa
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men or women 18 years of age or older
  • Confirmed diagnosis of multiple myeloma(MM) by Durie and Dalmon staging criteria on IV bisphosphonate therapy with either pamidronate or zoledronic acid for 8-12 months
  • MM patients in either CR or PR by EBMT criteria
  • ECOG Performance Status of 0-2

Exclusion Criteria:

  • MM patients on active anti-MM therapy (maintenance regimens allowed)
  • Renal failure with serum creatinine >2mg/dL and/or creatinine clearance of <30ml/min
  • Relapsed, refractory or progressive disease
  • Any condition or situation that, in the opinion of the investigator, may put the subject at significant risk, confound the results of the study, or interfere significantly with the subject's participation in the study
  • Hypersensitivity or any contraindication to a single dose of zoledronic acid
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577642
07-144, ASCO CDA
No
Noopur Raje, Massachusetts General Hospital
Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • American Society of Clinical Oncology
Principal Investigator: Noopur Raje, MD Massachusetts General Hospital
Massachusetts General Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP