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Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.

This study has been withdrawn prior to enrollment.
Information provided by:
Novartis Identifier:
First received: October 9, 2005
Last updated: April 13, 2015
Last verified: April 2015
To evaluate the safety and tolerability of intravenous zoledronic acid in the treatment of patients with multiple myeloma stage III with bone lesions related to Cancer.

Condition Intervention Phase
Multiple Myeloma
Drug: Zoledronic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.

Resource links provided by NLM:

Further study details as provided by Novartis:

Enrollment: 0
Study Start Date: April 2004

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
  • Confirmed Diagnosis of Durie-Salmon Stage III Multiple Myeloma, with the following clinical characteristics:

A. At least 1 osteolytic bone lesion demonstrable in a conventional X-ray film. B. The patient will have to be receiving treatment for primary neoplasia, at the time of the start of this trial.

- Ambulatory patients aged ≥ 18 years.

Exclusion Criteria:

  • Treatment with bisphosphonates in any moment during the last 12 months before visit 1. except for those patients that received only one dosis of bisphosphonates for any indication and when the administration has been 14 days before or older.
  • Patients with an absence of a bone lesion clearly related to the primary cancer, and that is detectable in a conventional bone X-ray (simple film).
  • Patients with a Serum Calcium level of ≤ 8 g/dl (2.00 mmol/L) or ≥ 12 mg/dL (3.00 mmol/L)
  • Treatment with other investigational drugs within 30 days before inclusion in the trial.
  • Serum Creatinine levels of > 3 mg/dl (265 umol/L).
  • Total Billirubin levels of > 2.5 mg/dl (43 umol/L)
  • Patients with a heart condition that has the NYHA criteria for a Grade III and IV functional class

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00242528

Sponsors and Collaborators
Study Chair: Novartis Novartis
  More Information Identifier: NCT00242528     History of Changes
Other Study ID Numbers: CZOL446EMX03
Study First Received: October 9, 2005
Last Updated: April 13, 2015

Keywords provided by Novartis:
Bone Lesions
Multiple Myeloma
zoledronic acid

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on May 25, 2017