A Multiple Myeloma Trial in Patients With Bone Metastases

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00104104
First received: February 22, 2005
Last updated: June 27, 2011
Last verified: June 2011
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months [ Time Frame: Baseline and 24 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Median time to event in participants who had a clinically relevant increase in serum creatinine.

  • Zoledronic Acid Concentrations [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104104

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

Additional Information:
No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00104104     History of Changes
Other Study ID Numbers: CZOL446EUS97, US97
Study First Received: February 22, 2005
Results First Received: January 6, 2011
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
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
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014