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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.

Primary Purpose

Multiple Myeloma

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Bone Lesions, Multiple Myeloma, zoledronic acid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 9, 2005
    Last Updated
    April 13, 2015
    Sponsor
    Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00242528
    Brief Title
    Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.
    Official Title
    Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    April 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Novartis

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma
    Keywords
    Bone Lesions, Multiple Myeloma, zoledronic acid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Zoledronic acid

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis
    Organizational Affiliation
    Novartis
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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