Maintenance Therapy Using Lenalidomide in Myeloma

Phase 3CompletedNCT00430365

University Hospital, Toulouse614 enrolled

Overview

Maintenance treatment of myeloma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

614

Conditions

Myeloma

Interventions

lenalidomideDRUG

oral drug

placeboDRUG

oral placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (77)

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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