INTERET D’UN TRAITEMENT D’ENTRETIEN PAR REVLIMID APRES AUTOGREFFE DE CELLULES SOUCHES CHEZ LES PATIENTS DE MOINS DE 65 ANS ATTEINTS DE MYELOME(Essai de phase III, multicentrique, randomisé, double aveugle, versus placebo) - IFM 2005-02

• Conditions: Myélome de novostade DS : III, II, I with one symptomatic bone ogique)No sign of cardia insufficiency and echography must schow FEV> 40 %.no hepatic insufficiency : bilirubine< 35µmol/L and SGOT,SGPT, alkaline phosphatases lower than 4 N.No respiratory insufficiency : DLCO >50 % N.no previous kidney insufficiencey non related to the disease and defined bycréatinine >160 µmol/L.Sérology HIV-; MedDRA version: 18.0Level: LLTClassification code 10028566Term: MyelomaSystem Organ Class: 100000004864; MedDRA version: 18.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-001554-24-BE
• Lead Sponsor: CHU de TOULOUSE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-08
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 614

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 <35µmol / L and SGOT, SGPT, alkaline phosphatase less than 4 N.
? No respiratory failure: ventilatory tests and DLCO> 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 <250 mmol / L.
? graft good quality according to the standards of each center (indicative = 5 X 106 CD34 / Kg / 1 for transplant)
? No other exclusion criteria (see diagnosis)
4-2 - Inclusion in the study (post-transplant randomization)
? Informed consent and patient's written
? post-transplant period = 6 months
? No signs of progression after transplantation (see Annex 3)
? Women of childbearing potential should have a serum pregnancy test (performed within 3 days before the start of treatment) negative. An effective method of contraception will also be used for the duration of maintenance therapy (oral contraceptives, injectable, transdermal or implantable, tubal ligation, IUD, contraceptive barrier using spermicides or partner's vasectomy). An additional method of birth control (condom) is highly recommended for the duration of treatment. Treatment should be delivered within 7 days after the completion of this test.
? No severe active infection
? satisfactory haematological reconstitution defined by: PN> 1000 / mm3 and Pads> 75,000 / mm3.
? Bilirubin <35 mmol / l and TGO / TGP / PAL <3N
? creatinine <160 mmol /
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Cfr Inclusion Criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified