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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00633542

Enrollment

103

Registered

2008-03-12

Start date

2003-06-30

Completion date

2007-10-31

Last updated

2008-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

thalidomide, maintenance, interferon, dexamethasone, newly diagnosed multiple myeloma, relapsed refractory multiple myeloma

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.

Interventions

DRUGthalidomide

100 mg/day orally until progression or severe toxicity

DRUGinterferon alpha

3 MU 3 times a week until progression or severe toxicity

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
progression free survival	3 years

Secondary

Measure	Time frame
overall survival safety	3 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026