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Stage I Multiple Myeloma Treatment (IFM-01-04)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00733538
First Posted: August 13, 2008
Last Update Posted: March 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
August 12, 2008
August 13, 2008
March 26, 2012
December 2004
November 2009   (Final data collection date for primary outcome measure)
Survival without progress [ Time Frame: every month during 6 years ]
Same as current
Complete list of historical versions of study NCT00733538 on ClinicalTrials.gov Archive Site
  • predictive factors of a fast evolution of multiple myeloma [ Time Frame: every month during 6 years ]
  • Secondary effects of zolédronate [ Time Frame: every month during six years ]
Same as current
Not Provided
Not Provided
 
Stage I Multiple Myeloma Treatment
Stage I Multiple Myeloma Treatment
  • Assessment of survival without progression of stage I MM in two groups: arm A: simple survey and arm B: administration of Zoledronate.
  • Describe different progression's type noticed and define the prognosis factors of a fast evolution.

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:

  • PRINCIPAL: Assessment of survival without progression stage I MM in two groups: A arm: simple survey and B arm: administration of BP.
  • SECONDARY: Describe different progression's type noticed (bone/extra bone) and define the prognosis factor of a fast stage I MM evolution (standard factors, cytogenetic 13 deletion, bone's restructuring strains: crosslaps, bone alkaline phosphatase), list side effects.

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.

  • Arm A: simple survey as standard practice.
  • Arm B: a 15 minutes infusion of Zoledronate every month until progression or a maximum of 18 infusions if no progression. The exams are the one usually defined according to good clinical practices guidelines besides cytogenetic, bone's restructuring strain and serum creatin dosage before each infusion in B arm.

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).

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
Drug: zometa
patients receiving treatment during their follow-up
  • Active Comparator: 1
    patients receiving zometa treatment
    Intervention: Drug: zometa
  • No Intervention: 2
    No treatment, just follow-up
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
350
November 2012
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • stage I multiple myeloma without bones injuries

Exclusion Criteria:

  • abnormal kidney function
  • VIH infection
  • Hepatic incapacity
  • pregnancy
  • Associate pathology
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00733538
IFM-04-01
No
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
Principal Investigator: Jean-Gabriel FUZIBET, PU-PH service de médecine interne, CHU de Nice
Centre Hospitalier Universitaire de Nice
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP