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

Università Politecnica delle Marche

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: thalidomide; Drug: interferon alpha

Study type: Interventional

Funder types: Other

Identifiers

NCT00633542

AIL 2002

MO 02/02 MM

Details and patient eligibility

About

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

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

TD

Experimental group

Description:

thalidomide-dexamethasone

Treatment:

Drug: thalidomide

ID

Active Comparator group

Description:

Interferon-dexamethasone

Treatment:

Drug: interferon alpha