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

Sponsor

Università Politecnica delle Marche (Other)

Overall Status

Completed

CT.gov ID

NCT00633542

Collaborator

(none)

103

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: thalidomide Drug: interferon alpha	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TD thalidomide-dexamethasone	Drug: thalidomide 100 mg/day orally until progression or severe toxicity
Active Comparator: ID Interferon-dexamethasone	Drug: interferon alpha 3 MU 3 times a week until progression or severe toxicity

Arm

Intervention/Treatment

Experimental: TD

thalidomide-dexamethasone

Drug: thalidomide

100 mg/day orally until progression or severe toxicity

Active Comparator: ID

Interferon-dexamethasone

Drug: interferon alpha

3 MU 3 times a week until progression or severe toxicity

Outcome Measures

Primary Outcome Measures

progression free survival [3 years]

Secondary Outcome Measures

overall survival safety [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica di ematologia ospedali riuniti ancona università politecnica delle marche	Ancona		Italy	60020

Sponsors and Collaborators

Università Politecnica delle Marche

Investigators

Principal Investigator: Offidani Massimo, MD, clinica di ematologia ospedali riuniti ancona università politecnica delle marche
Study Chair: Pietro Leoni, MD, PhD, clinica di ematologia università politecnica delle marche