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).
Inclusion Criteria:

 -  stage I multiple myeloma without bones injuries

 Exclusion Criteria:

 -  abnormal kidney function

 -  VIH infection

 -  Hepatic incapacity

 -  pregnancy

 -  Associate pathology