Clinical trial NCT00633542: Maintenance Therapy After Thalidomide-Dexamethasone(ThaDD) for Multiple Myeloma(MM)
Official title: Thalidomide-Dexamethasone vs Alpha-Interferon-Dexamethasone as Maintenance Therapy After Thalidomide, Dexamethasone and Pegylated Liposomal Doxorubicin Combination for
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: thalidomide
maintenance
interferon
dexamethasone
newly diagnosed multiple myeloma
relapsed refractory multiple myeloma
Lead sponsor: Università Politecnica delle Marche
Sponsor class: OTHER
First posted: 2008-03-12
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: progression free survival
timeFrame: 3 years
Secondary outcomes:
measure: overall survival safety
timeFrame: 3 years
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Clinica di ematologia ospedali riuniti ancona università politecnica delle marche
Study officials:
affiliation: clinica di ematologia ospedali riuniti ancona università politecnica delle marche
name: Offidani Massimo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: clinica di ematologia università politecnica delle marche
name: Pietro Leoni, MD, PhD
role: STUDY_CHAIR
References:
citation: Offidani M, Corvatta L, Piersantelli MN, Visani G, Alesiani F, Brunori M, Galieni P, Catarini M, Burattini M, Centurioni R, Ferranti M, Rupoli S, Scortechini AR, Giuliodori L, Candela M, Capelli D, Montanari M, Olivieri A, Poloni A, Polloni C, Marconi M, Leoni P. Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma. Blood. 2006 Oct 1;108(7):2159-64. doi: 10.1182/blood-2006-03-013086. Epub 2006 Jun 8.