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Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Patients (Z-MARK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00622505
First received: February 14, 2008
Last updated: February 18, 2013
Last verified: February 2013

February 14, 2008
February 18, 2013
November 2007
April 2012   (final data collection date for primary outcome measure)
Proportion of patients with ≥1 SRE at the end of one year on study. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00622505 on ClinicalTrials.gov Archive Site
Time to first SRE on study, proportion of each type of SRE, SRE rate, biomarker changes, and survival. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Patients
Bone Marker Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Advanced Multiple Myeloma

This study will evaluate the effectiveness and safety of a dosing method for zoledronic acid in preventing skeletal complications in multiple myeloma patients who have been on an IV bisphosphonate for about one to two years.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Multiple Myeloma
Drug: zoledronic acid
4 mg either 4 or 12 weeks for 96 weeks
Other Name: Zometa
Experimental: zoldronic acid
Intervention: Drug: zoledronic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed diagnosis of multiple myeloma
  • Have been on zoledronic acid or pamidronate for 1-2 years and therapy must have been initiated for osteolytic lesion, bone fracture, spinal compression or osteopenia due to multiple myeloma
  • Stable renal function

Exclusion Criteria:

  • Known sensitivity to bisphosphonates
  • Receiving investigational drugs considered not safe for co-administration or have significant effect on bone turnover
  • Current active dental problems
  • Had bone marrow transplant or blood stem cell transplant within 2 months before study entry or planned transplant within 2 months following enrollment

Other protocol-defined inclusion/exclusion criteria may apply.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00622505
CZOL446EUS129
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2013

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