Myélome de novo stade DS : III, II, I with one symptomatic bone ogique) No sign of cardia insufficiency and echography must schow FEV> 40 %. no hepatic insufficiency : bilirubine50 % N. no previous kidney insufficiencey non related to the disease and defined bycréatinine >160 µmol/L. Sérology HIV- MedDRA version: 18.0 Level: LLT Classification code 10028566 Term: Myeloma System Organ Class: 100000004864 MedDRA version: 18.0 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: REVLIMID (LENALIDOMIDE)
Product Name: Revlimid Lenalidomide
Pharmaceutical Form: Capsule
Other descriptive name: Lenalidomide or Revlimid or Alpha-3-aminophtalimido glutarimide
Concentrati
Sponsors
CHU de TOULOUSE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 4 - CRITERES D’ELIGIBILITE ET D’INCLUSION 4-1 - Selection 4-1 - 1 - pre-autograft Period ? novo Myeloma ? In stage DS: III, II, I with one symptomatic bone lesion (radiological) ? Age between 18 and 65 years ? Volunteer affiliated to a social security scheme ? No clinical signs of heart or coronary insufficiency and sonographic plane February> 40%. ? No liver injury bilirubin 50% N. ? No previous renal disease not related to the disease and defined by a creatinine> 160 mmol / L. ? No history of another malignancy except basal cell carcinoma and stage of cervical cancer I. ? Serology HIV- ? Women of childbearing potential should have a serum or urine pregnancy test (done within 7 days before the start of treatment) negative. An effective method of contraception will also be used throughout the duration of treatment (oral contraceptives, injectable, transdermal or implantable, tubal ligation, IUD, contraceptive barrier using spermicides or partner's vasectomy). 4-1 - 2 - Period autograft ? Good general condition (WHO code 2; Appendix 2). ? creatinine 1000 / mm3 and Pads> 75,000 / mm3. ? Bilirubin =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Cfr Inclusion Criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to determine efficacy of revlimid to prolong survival without porgression after autograft.;Secondary Objective: - progression free-survial from date of diagnosis - overall survival - time to progression - response analysis othe response rate (at least PR) othe duration of response (atleast PR) othe duration of the complete response (CR) otime to the best answer othe quantitative variation of the monclonal peak - evalutae the long-term tolerance of revlimid consolidation treatment and post-transplant maintenance ;Primary end point(s): Complete blood counts will be monitored weekly for the first 2 months and then one time every 15 days during the following 2 months and 1 monthly thereafter. The dose of Revlimid will be tailored to the figures of PN and platelets: if with 1 tablet per day, the number of PN is less than 500 / mm3 or the platelet count is less than 25,000 / mm3, treatment should be interrupted and resumed at a dose of 1 tablet (if PN and Plaq are required levels). If the number of PN is again less than 500 / mm3 or the platelet count is less than 25,000 / mm3, the treatment will be finalized. At any time, the protocol may be interrupted: * at the patient's request (withdrawal of consent) * if * increase * in case of death of sight * new cancer treatment Unblinding must be requested by mail, fax or mail to the coordinator investigator (fax: 05 61 77 94 62).;Timepoint(s) of evaluation of this end point: Complete blood counts will be monitored weekly for the first 2 months and then one time every 15 days during the following 2 months and 1 monthly thereafter. The dose of Revlimid will be tailored to the figures of PN and platelets: If the number of PN is again less than 500 / mm3 or the platelet count is less than 25,000 / mm3, the treatment will be finalized. At any time, the protocol may be interrupted: * at the patient's request (withdrawal of consent) * if * increase * in case of death of sight * new cancer treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - progression free-survial from date of diagnosis - overall survival - time to progression - response analysis o the response rate (at least PR) o the duration of response (atleast PR) o the duration of the complete response (CR) o time to the best answer o the quantitative variation of the monclonal peak - evalutae the long-term tolerance of revlimid consolidation treatment and post-transplant maintenance ;Timepoint(s) of evaluation of this end point: Planned analyses: 2 (interim and final analyses) | — |
Countries
Belgium, France, Switzerland
Outcome results
None listed