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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00242528
• Other study ID #: CZOL446EMX03
• Status: Withdrawn
• Phase: Phase 4
• First received: October 9, 2005
• Last updated: April 13, 2015
• Start date: April 2004

Study information

• Verified date: April 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Zoledronic acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis