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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This study has been withdrawn prior to recruitment.
First Received: October 9, 2005   Last Updated: August 17, 2006   History of Changes
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00242528
  Purpose

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 IV

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Zoledronic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Open-Label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.

Further study details as provided by Novartis:

Study Start Date: April 2004
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242528

Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

Study ID Numbers: CZOL446EMX03
Study First Received: October 9, 2005
Last Updated: August 17, 2006
ClinicalTrials.gov Identifier: NCT00242528     History of Changes
Health Authority: Mexico: Ethics Committee

Keywords provided by Novartis:
Bone Lesions
Multiple Myeloma
zoledronic acid

Study placed in the following topic categories:
Immunoproliferative Disorders
Zoledronic acid
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Bone Density Conservation Agents
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Diphosphonates
Hemorrhagic Disorders
Neoplasm Metastasis
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Zoledronic acid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Physiological Effects of Drugs
Vascular Diseases
Bone Density Conservation Agents
Paraproteinemias
Hemostatic Disorders
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Diphosphonates
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009