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

Study Overview
=================
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.

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

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: thalidomide
* Drug: interferon alpha


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival safety |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thalidomide, maintenance, interferon, dexamethasone, newly diagnosed multiple myeloma, relapsed refractory multiple myeloma