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Completed

NCT Number: NCT00104104

A Multiple Myeloma Trial in Patients With Bone Metastases

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hematology Oncology Specialists, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zoledronic acid

Drug

4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.

Other names: ZOMETA®

Primary outcomes

  1. 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.

  2. The Number of Participants With Disease Progression

    Time frame: 24 Months

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Feb 23, 2005
Registry last updated
Jun 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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