Maintenance Therapy Using Lenalidomide in Myeloma

Phase 3

Completed

• Conditions: Myeloma
• Interventions: Drug: placebo; Drug: lenalidomide

• Registration Number: NCT00430365
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Maintenance treatment of myeloma.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-01-31
• Study First Submitted QC: 2007-01-31
• Study First Posted: 2007-02-01
• Primary Completion: 2017-09
• Study Completion: 2018-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 614

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	placebo	Administration of oral placebo
lenalidomide group	lenalidomide	Administration of lenalidomide

Primary Outcome Measures

Name	Time	Method
Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.	2 years

Secondary Outcome Measures

Name	Time	Method
Assess the impact of Revlimid® on the post-transplant complete response rate	2 years
Compare survival without events and overall survival of patients in the lenalidomide arm with the control	2 years
Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy.	3 years

Trial Locations

Locations (72)

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

Algemeen Centrumziekenhuis Antwerpen; 🇧🇪 Antwerpen, Belgium

UZA Antwerpen; 🇧🇪 Antwerpen, Belgium

Hôpital Saint Joseph; 🇧🇪 Gilly, Belgium

Institut Jules Bordet; 🇧🇪 Bruxelles, Belgium

UCL St Luc; 🇧🇪 Bruxelles, Belgium

Hôpital Jolimont; 🇧🇪 Haine Saint Paul, Belgium

Heilig Hart Ziekenhuis; 🇧🇪 Roeselare, Belgium

UCL Mont-Godinne; 🇧🇪 Yvoir, Belgium

CH; 🇫🇷 Le Mans, France

Scroll for more (62 remaining)