Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma

PHASE3CompletedINTERVENTIONAL
Enrollment

213

Participants

Timeline

Start Date

October 31, 2003

Primary Completion Date

July 31, 2008

Study Completion Date

December 31, 2010

Conditions
Multiple Myeloma
Interventions
DRUG

Thalidomide plus dexamethasone

"D+60 after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days) and Arm B (dexamethasone plus thalidomide 200 mg by mouth daily) for 12 months or until disease progression.~The dose of thalidomide could be reduced if the patient experienced grade 2 or higher adverse events. In this case, thalidomide was discontinued and re-challenged at a lower dose after resolution of the adverse event."

DRUG

Dexamethasone

dexamethasone alone 40 mg/day for 4 days every 28 days

Trial Locations (4)

21941913

Hospital Universitário Clementino Fraga Filho, Rio de Janeiro

Unknown

Universidade Estadual de Campinas, Campinas

Universidade de São Paulo- Ribeirão Preto, Ribeirão Preto

Santa Casa de Misericórdia de São Paulo, São Paulo

All Listed Sponsors
lead

Grupo de Estudos Multicentricos em Onco-Hematologia

NETWORK

NCT01296503 - Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma | Biotech Hunter | Biotech Hunter