Maintenance Therapy Using Lenalidomide in Myeloma (IFM2005-02)

• ClinicalTrials.gov Identifier: NCT00430365
• Recruitment Status: Completed
• First Posted: February 1, 2007
• Last Update Posted: April 26, 2019
• Sponsor: University Hospital, Toulouse
• Collaborators: Intergroupe Francophone du Myelome; Celgene
• Information provided by (Responsible Party): University Hospital, Toulouse

Tracking Information

• First Submitted Date: January 31, 2007
• First Posted Date: February 1, 2007
• Last Update Posted Date: April 26, 2019
• Actual Study Start Date: June 2006
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 28, 2008): Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response. [ Time Frame: 2 years ]
• Original Primary Outcome Measures (submitted: January 31, 2007): Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.

Current Secondary Outcome Measures (submitted: January 28, 2008)

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

Original Secondary Outcome Measures (submitted: January 31, 2007)

• Assess the impact of Revlimid® on the post-transplant complete response rate
• Compare survival without events and overall survival of patients in the Revlimid® arm with the control
• Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Maintenance Therapy Using Lenalidomide in Myeloma
• Official Title: 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).
• Brief Summary: Maintenance treatment of myeloma.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Myeloma

Intervention

• Drug: lenalidomide
  oral drug
  Other Name: REVLIMID
• Drug: placebo
  oral placebo

Study Arms

• Placebo Comparator: placebo group
  Administration of oral placebo
  Intervention: Drug: placebo
• Experimental: lenalidomide group
  Administration of lenalidomide
  Intervention: Drug: lenalidomide

Publications *

• Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42. doi: 10.1200/JCO.1998.16.12.3832.
• Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, Stoppa AM, Hulin C, Benboubker L, Garderet L, Decaux O, Leyvraz S, Vekemans MC, Voillat L, Michallet M, Pegourie B, Dumontet C, Roussel M, Leleu X, Mathiot C, Payen C, Avet-Loiseau H, Harousseau JL; IFM Investigators. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012 May 10;366(19):1782-91. doi: 10.1056/NEJMoa1114138.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: January 31, 2007): 614
• Original Enrollment: Same as current
• Actual Study Completion Date: September 2018
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, France, Switzerland

Administrative Information

• NCT Number: NCT00430365
• Other Study ID Numbers: 0400401; French PHRC ( Other Grant/Funding Number: 0400401 )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Toulouse
• Original Responsible Party: Not Provided
• Current Study Sponsor: University Hospital, Toulouse
• Original Study Sponsor: Same as current

Collaborators

• Intergroupe Francophone du Myelome
• Celgene

Investigators

• Principal Investigator: ATTAL Michel, Pr; University Hospital, Toulouse

• PRS Account: University Hospital, Toulouse
• Verification Date: April 2019