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

NCT ID: NCT00633542

Last Updated: 2008-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2007-10-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TD

thalidomide-dexamethasone

Group Type: EXPERIMENTAL

thalidomide

Intervention Type: DRUG

100 mg/day orally until progression or severe toxicity

ID

Interferon-dexamethasone

Group Type: ACTIVE_COMPARATOR

interferon alpha

Intervention Type: DRUG

3 MU 3 times a week until progression or severe toxicity

Interventions

thalidomide

100 mg/day orally until progression or severe toxicity

Intervention Type: DRUG

interferon alpha

3 MU 3 times a week until progression or severe toxicity

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università Politecnica delle Marche

OTHER

Sponsor Role: lead

Responsible Party

Clinica di Ematologia Università Politecnica delle Marche

Principal Investigators

Offidani Massimo, MD

Role: PRINCIPAL_INVESTIGATOR

clinica di ematologia ospedali riuniti ancona università politecnica delle marche

Pietro Leoni, MD, PhD

Role: STUDY_CHAIR

clinica di ematologia università politecnica delle marche

Locations

Clinica di ematologia ospedali riuniti ancona università politecnica delle marche

Ancona, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 16763209 (View on PubMed)

Other Identifiers

AIL 2002

Identifier Type: -

Identifier Source: secondary_id

MO 02/02 MM

Identifier Type: -

Identifier Source: org_study_id