Know Cancer

or
forgot password

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).


Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Myeloma

Thank you

Trial Information

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).


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

ATTAL Michel, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Toulouse

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

0400401

NCT ID:

NCT00430365

Start Date:

June 2006

Completion Date:

June 2015

Related Keywords:

  • Myeloma
  • Myeloma
  • Revlimid
  • Maintenance therapy
  • Autologous Stem Cell Transplantation
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location