Multiple MyelomaPhase 4IFM-01-04NCT00733538
Stage I Multiple Myeloma Treatment
A Phase 4 study testing zometa in people with Multiple Myeloma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- zometa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2004to Nov 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage I multiple myeloma without bones injuries
Who cannot join
- abnormal kidney function
- VIH infection
- Hepatic incapacity
- pregnancy
- Associate pathology
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Medecine interne, Hôpital l'ARCHET, CHU de Nice
Nice, 06202
About this study
- 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.
Read the 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).
- Conditions
- Multiple Myeloma
- Being tested
- zometa
- Keywords
- stage I multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zometaDrug
patients receiving treatment during their follow-up
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | patients receiving zometa treatment Receives: Drug: zometa |
| 2 | No intervention | No treatment, just follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without progress
Measured: every month during 6 years
Secondary outcomes (2)
predictive factors of a fast evolution of multiple myeloma
Measured: every month during 6 years
Secondary effects of zolédronate
Measured: every month during six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startDec 2004
- Primary completionNov 2009
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Gabriel FUZIBET, PU-PH, Principal investigator, service de médecine interne, CHU de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733538
- Sponsor's protocol ID
- IFM-04-01
- Acronym
- IFM-01-04
- Status last verified
- Feb 2009
- First submitted
- 12 Aug 2008
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stage I Multiple Myeloma Treatment
- ClinicalTrials.gov ID
- NCT00733538
- Acronym / sponsor ID
- IFM-01-04 / IFM-04-01
- Conditions
- Multiple Myeloma
- Keywords
- stage I multiple myeloma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: zometapatients receiving zometa treatment |
| 2 | No intervention | –No treatment, just follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stage I multiple myeloma without bones injuries
Key exclusion criteria (5 listed)
- abnormal kidney function
- VIH infection
- Hepatic incapacity
- pregnancy
- Associate pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zometapatients receiving treatment during their follow-up | Drug | 1 |
Primary outcome
Survival without progress
Time frame: every month during 6 years
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Gabriel FUZIBET, PU-PH principal investigator
service de médecine interne, CHU de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing zometa in people with Multiple Myeloma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without progress (time frame: every month during 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.