NCT00633542

Maintenance Therapy After Thalidomide-Dexamethasone(ThaDD) for Multiple Myeloma(MM)

Thalidomide-Dexamethasone vs Alpha-Interferon-Dexamethasone as Maintenance Therapy After Thalidomide, Dexamethasone and Pegylated Liposomal Doxorubicin Combination for

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Università Politecnica delle Marche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is randomized, multicentre study aimed to compare a standard maintenance therapy with Interferon-Dexamethasone with an experimental therapy based on Thalidomide-Dexamethasone in patients with multiple myeloma who responded to ThaDD induction therapy

Detailed description

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	thalidomide	100 mg/day orally until progression or severe toxicity
DRUG	interferon alpha	3 MU 3 times a week until progression or severe toxicity

Timeline

• Start date: 2003-06-01
• Primary completion: 2007-09-01
• Completion: 2007-10-01
• First posted: 2008-03-12
• Last updated: 2008-03-12

Locations

1 site across 1 country: Italy