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

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

This study is currently recruiting participants.

Verified by Novartis, July 2009

First Received: February 14, 2008 Last Updated: July 7, 2009 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00622505

Purpose

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	Intervention	Phase
Multiple Myeloma	Drug: zoledronic acid	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Bone Marker Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Advanced Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Proportion of patients with ≥1 SRE at the end of one year on study. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	120
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

4 mg either 4 or 12 weeks for 96 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622505

Contacts

Contact: Novartis Oncology

800-340-6843

Show 62 Study Locations

Sponsors and Collaborators

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CZOL446EUS129
Study First Received:	February 14, 2008
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00622505 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Multiple myeloma
zoledronic acid
skeletal complications
bone

Study placed in the following topic categories:

Immunoproliferative Disorders
Zoledronic acid
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Bone Density Conservation Agents

Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Diphosphonates
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Zoledronic acid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Physiological Effects of Drugs
Vascular Diseases
Bone Density Conservation Agents
Paraproteinemias

Hemostatic Disorders
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Diphosphonates
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on September 03, 2009