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Sponsored by: |
Centre Hospitalier Universitaire de Nice |
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Information provided by: | Centre Hospitalier Universitaire de Nice |
ClinicalTrials.gov Identifier: | NCT00733538 |
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: zometa |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Stage I Multiple Myeloma Treatment |
Estimated Enrollment: | 350 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
patients receiving zometa treatment
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Drug: zometa
patients receiving treatment during their follow-up
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2: No Intervention
No treatment, just follow-up
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RATIONAL:
Multiple Myeloma in spite of therapy progresses mainly due to stem cell auto transplant, still remain a deadly disease. About 2000 new cases are diagnosed every year in France. The asymptomatic Stage I MM according to Duries and Salmon's staging are usually only watch over and only treated at progression. Zoledronate is a third generation aminobiphosphonate (BP), probably the most powerful among the available compounds which received market clearance authorisation in MM with bone damage. During MM, bone's hyper resorption is premature. Interactions exist between tumor growth and bone lyses.
Zoledronate's got a proper antimyeloma's action (induce plasma cells apoptosis). We propose to test the early use of Zoledronate as soon as stage I MM to delay progression.
STUDY'S OBJECTIVES:
STUDY'S KIND:
Multicenter international randomised trial, open labelled, with individual profit.
CONTRIBUTING CENTERS:
Intergroupe Francophone du Myélome's centers.
INCLUSIONS CRITERIA:
Asymptomatic stage I MM without bone's lesion on the standard radiographs.
STUDY'S MONITORING:
After checking inclusion and non inclusion specifications, the patient will be included in the study and randomized (A arm or B arm) before all treatment. The randomisation will be done by center and stratified according to the diagnostic date witch a year or not.
STATISTICAL PURPOSES:
The minimum number of patients required showing a median survival time increase without progression of 26 months in the control arm and 38 months in the BP arm is about 175 patients in each arm for a 48 months inclusion's period, and a monitoring of 24 months after the last inclusion (i.e. a study's length of 6 years).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jean-Gabriel FUZIBET, PU-PH | 0492035407 | fuzibet.jg@chu-nice.fr |
France | |
Service de Medecine interne, Hôpital l'ARCHET, CHU de Nice | Recruiting |
NICE, France, 06202 | |
Contact: Jean-Gabriel FUZIBET, PU-PH 0492035407 fuzibet.jg@chu-nice.fr |
Principal Investigator: | Jean-Gabriel FUZIBET, PU-PH | service de médecine interne, CHU de Nice |
Responsible Party: | Centre Hospitalier Universitaire de Nice ( Département de la Recherche Clinique et de l'Innovation ) |
Study ID Numbers: | IFM-04-01 |
Study First Received: | August 12, 2008 |
Last Updated: | February 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00733538 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority; France: Institutional Ethical Committee; France: Ministry of Health |
stage I multiple myeloma |
Zoledronic acid Immunoproliferative Disorders Hemorrhagic Disorders Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders |
Vascular Diseases Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |