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

Phase 3

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: interferon alpha; Drug: thalidomide

• Registration Number: NCT00633542
• Lead Sponsor: Università Politecnica delle Marche

Brief 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.

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2007-09
• Study Completion: 2007-10
• Study First Submitted: 2008-01-02
• Status Verified: 2008-03
• Study First Submitted QC: 2008-03-04
• Last Update Submitted: 2008-03-04
• Study First Posted: 2008-03-12
• Last Update Posted: 2008-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• patients with newly diagnosed or advanced multiple myeloma achieving at least a minimal response after induction with ThaDD regimen
• Written consent

Exclusion Criteria

• peripheral neuropathy >= grade 2
• neutropenia < 1000/mcl or thrombocytopenia < 50000/mcl
• severe depression
• organ disfunction > grade 2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ID	interferon alpha	Interferon-dexamethasone
TD	thalidomide	thalidomide-dexamethasone

Primary Outcome Measures

Name	Time	Method
progression free survival	3 years

Secondary Outcome Measures

Name	Time	Method
overall survival safety	3 years

Trial Locations

Locations (1)

Clinica di ematologia ospedali riuniti ancona università politecnica delle marche; 🇮🇹 Ancona, Italy