NCT00242528

Brief 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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 20, 2005

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

First QC Date

October 9, 2005

Last Update Submit

April 13, 2015

Conditions

Multiple Myeloma

Keywords

Bone LesionsMultiple Myelomazoledronic acid

Interventions

Zoledronic acidDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis

    Novartis

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 9, 2005

First Posted

October 20, 2005

Study Start

April 1, 2004

Last Updated

April 14, 2015

Record last verified: 2015-04