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

April 11, 2024 updated by: Centre Hospitalier Universitaire de Nice
  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06202
        • Service de Medecine interne, Hôpital l'ARCHET, CHU de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • stage I multiple myeloma without bones injuries

Exclusion Criteria:

  • abnormal kidney function
  • VIH infection
  • Hepatic incapacity
  • pregnancy
  • Associate pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
patients receiving zometa treatment
Drug: zometa
patients receiving treatment during their follow-up
No Intervention: 2
No treatment, just follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival without progress
Time Frame: every month during 6 years
every month during 6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
predictive factors of a fast evolution of multiple myeloma
Time Frame: every month during 6 years
every month during 6 years
Secondary effects of zolédronate
Time Frame: every month during six years
every month during six years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Jean-Gabriel FUZIBET, PU-PH, service de médecine interne, CHU de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (Estimated)

August 13, 2008

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFM-04-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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