Maintenance Therapy Using Lenalidomide in Myeloma (IFM2005-02)

Toulouse University Hospital

Status and phase: Completed; Phase 3

Conditions: Myeloma

Treatments: Drug: placebo; Drug: lenalidomide

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT00430365

0400401

French PHRC (Other Grant/Funding Number)

Details and patient eligibility

About

Maintenance treatment of myeloma.

Enrollment: 614 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

614 participants in 2 patient groups, including a placebo group

placebo group

Placebo Comparator group

Description:

Administration of oral placebo

Treatment:

Drug: placebo

lenalidomide group

Experimental group

Description:

Administration of lenalidomide

Treatment:

Drug: lenalidomide