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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00622505
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: zoledronic acid Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Bone Marker Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Advanced Multiple Myeloma
Study Start Date : November 2007
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: zoldronic acid Drug: zoledronic acid
4 mg either 4 or 12 weeks for 96 weeks
Other Name: Zometa


Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients with ≥1 SRE at the end of one year on study. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Time to first SRE on study, proportion of each type of SRE, SRE rate, biomarker changes, and survival. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

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): NCT00622505


  Show 42 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00622505     History of Changes
Other Study ID Numbers: CZOL446EUS129
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple myeloma
zoledronic acid
skeletal complications
bone

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs