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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633542
• Other study ID #: MO 02/02 MM
• Secondary ID: AIL 2002
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2008
• Last updated: March 4, 2008
• Start date: June 2003
• Est. completion date: October 2007

Study information

• Verified date: March 2008
• Source: Università Politecnica delle Marche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• thalidomide
100 mg/day orally until progression or severe toxicity
• interferon alpha
3 MU 3 times a week until progression or severe toxicity

Locations

Country	Name	City	State
Italy	Clinica di ematologia ospedali riuniti ancona università politecnica delle marche	Ancona

Sponsors (1)

Lead Sponsor	Collaborator
Università Politecnica delle Marche

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. Epub 2006 Jun 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		3 years	No
Secondary	overall survival safety		3 years	Yes