Thalidomide-Dexamethasone vs Alpha-Interferon-Dexamethasone as Maintenance Therapy After Thalidomide, Dexamethasone and Pegylated Liposomal Doxorubicin Combination for
Thalidomide has already been used as maintenance and/or consolidation after high-dose
therapy followed by autologous stem cell transplantation. Despite a number of phase II and
III studies the issues of right dose and duration of thalidomide and subsets of patients
benefiting from it have not yet been settled We explored the maintenance therapy after
thalidomide, dexamethasone and pegylated liposomal doxorubicin called ThaDD protocol.
Patients with de novo or relapsed MM obtaining at least minor response after 4 to 6 ThaDD
courses, were randomized to receive standard maintenance therapy with IFN 3 MU 3 times a
week or an experimental maintenance therapy such as thalidomide 100 mg per day until relapse
or intolerable side effects. Both groups also received pulsed dexamethasone 20 mg 4 days a
month.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
progression free survival
3 years
No
Offidani Massimo, MD
Principal Investigator
clinica di ematologia ospedali riuniti ancona università politecnica delle marche
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
MO 02/02 MM
NCT00633542
June 2003
October 2007
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