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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This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00242528
First received: October 9, 2005
Last updated: November 20, 2009
Last verified: November 2009

October 9, 2005
November 20, 2009
April 2004
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Complete list of historical versions of study NCT00242528 on ClinicalTrials.gov Archive Site
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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.
Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: Zoledronic acid
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
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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.

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00242528
CZOL446EMX03
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Novartis
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Study Chair: Novartis Novartis
Novartis
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP