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A Multiple Myeloma Trial in Patients With Bone Metastases

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00104104
First Posted: February 23, 2005
Last Update Posted: June 29, 2011
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.
Information provided by:
Novartis
  Purpose
The purpose of this trial is to study the safety of treating patients with multiple myeloma and at least one bone lesion with zoledronic acid 4mg intravenously (IV) every 3 - 4 weeks for 2 years. Patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes.

Condition Intervention Phase
Multiple Myeloma Drug: zoledronic acid Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter,Open Label, Randomized Trial Evaluating the Duration of Infusion of Zoledronic Acid 4 mg IV in Multiple Myeloma Patients With Bone Metastases

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months [ Time Frame: Baseline and 12 Months ]
    The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.

  • The Number of Participants With Disease Progression [ Time Frame: 24 Months ]

Secondary Outcome Measures:
  • The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months [ Time Frame: Baseline and 24 Months ]
    Serum Creatinine was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.

  • Time to First Significant Increase in Serum Creatinine [ Time Frame: Up to 24 months ]
    Median time to event in participants who had a clinically relevant increase in serum creatinine.

  • Zoledronic Acid Concentrations [ Time Frame: 24 months ]
    Samples for drug concentration analysis were drawn at 10 and 15 minutes into the infusion for participants in the 15-minute infusion group and at 25 and 30 minutes into the infusion for patients in the 30-minute infusion group. The mean and median zoledronic acid concentrations were greater in the 15-minute group than in the 30-minute group at both sampling timepoints.


Enrollment: 179
Study Start Date: October 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15 Minute Infusion
Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks
Drug: zoledronic acid
4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
Other Name: ZOMETA®
Experimental: 30 Minute Infusion
Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
Drug: zoledronic acid
4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
Other Name: ZOMETA®

  Eligibility

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:

  • Patients 18 years of age or older
  • Confirmed diagnosis of Multiple Myeloma
  • Stable renal function defined as two serum creatinine determinations of < 3 mg/dL
  • Calculated creatinine clearance of greater than or equal to 30 mL/min
  • ECOG Performance Status of 0 or 1
  • Life expectancy of greater than or equal to 9 months
  • If the patient is of child-bearing potential, a negative pregnancy test is required at screening, while postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Ability to comply with trial requirements and give informed consent.

Exclusion Criteria:

  • IV Bisphosphonate therapy for more than 3 years.
  • Patients with a diagnosis of amyloidosis.
  • Known hypersensitivity to zoledronic acid or other bisphosphonates
  • Pregnant patients or lactating patients.
  • Women of childbearing potential not on a medically recognized form of contraception
  • Patients with uncontrolled cardiovascular disease, hypertension, and Type 2 diabetes mellitus.
  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): NCT00104104


  Show 68 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00104104     History of Changes
Other Study ID Numbers: CZOL446EUS97
US97
First Submitted: February 22, 2005
First Posted: February 23, 2005
Results First Submitted: January 6, 2011
Results First Posted: June 6, 2011
Last Update Posted: June 29, 2011
Last Verified: June 2011

Keywords provided by Novartis:
Z-MAX, multiple myeloma, zoledronic acid, bone metastases

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm Metastasis
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
Neoplastic Processes
Pathologic Processes
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs