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OpenTrials
Completed

NCT Number: NCT00430365

Maintenance Therapy Using Lenalidomide in Myeloma

Maintenance treatment of myeloma.

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Key information

Conditions

Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Algemeen Centrumziekenhuis Antwerpen, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lenalidomide

Drug

oral drug

Other names: REVLIMID

Placebo

Drug

oral placebo

Primary outcomes

  1. Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.

    Time frame: 2 years

Secondary outcomes

  1. Assess the impact of Revlimid® on the post-transplant complete response rate

    Time frame: 2 years

  2. Compare survival without events and overall survival of patients in the lenalidomide arm with the control

    Time frame: 2 years

  3. Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Celgene
  • Intergroupe Francophone du Myelome

Registry information

Official study 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).

Acronym: IFM2005-02

Important dates

Study start
2006
Primary completion
2017
Study completion
2018
First posted
Feb 1, 2007
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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