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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00430365 |
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Date of registration:
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31/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Maintenance Therapy Using Lenalidomide in Myeloma
IFM2005-02 |
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Scientific title:
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Relevance of Maintenance Therapy Using Lenalidomide (Revimid®) After Autologous Stem Cell Transplantation Patients Under the Age Of 65. (Open, Randomised, Multi-centric Trial Versus Placebo). |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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614 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00430365 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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France
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Switzerland
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Contacts
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Name:
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ATTAL Michel, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Toulouse |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- No signs of progression after transplant
- Effective contraception if necessary (oral contraception for females and barrier
methods of contraception for sexually active males)
- No active severe infection
- Satisfactory restoration of the haematological parameters defined by: PN >1,000/mm3
and Platelets > 75,000/mm3
- Bilirubin < 35 umol/l and GOT/GPT/PAL<3N
- Creatinine < 160 umol/l.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Myeloma
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Intervention(s)
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Drug: placebo
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Drug: lenalidomide
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Primary Outcome(s)
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Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.
[Time Frame: 2 years]
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Secondary Outcome(s)
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Compare survival without events and overall survival of patients in the lenalidomide arm with the control
[Time Frame: 2 years]
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Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy.
[Time Frame: 3 years]
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Assess the impact of Revlimid® on the post-transplant complete response rate
[Time Frame: 2 years]
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Secondary ID(s)
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0400401
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French PHRC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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