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

Sponsored by:	Università Politecnica delle Marche
Information provided by:	Università Politecnica delle Marche
ClinicalTrials.gov Identifier:	NCT00633542

Purpose

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

Condition	Intervention	Phase
Multiple Myeloma	Drug: thalidomide Drug: interferon alpha	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Thalidomide-Dexamethasone vs Alpha-Interferon-Dexamethasone as Maintenance Therapy After Thalidomide, Dexamethasone and Pegylated Liposomal Doxorubicin Combination for

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Dexamethasone Thalidomide Dexamethasone acetate Doxiproct plus Interferon alfa-2a Interferon alfa-n1 Dexamethasone Sodium Phosphate Interferons

U.S. FDA Resources

Further study details as provided by Università Politecnica delle Marche:

Primary Outcome Measures:

progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

overall survival safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment:	103
Study Start Date:	June 2003
Study Completion Date:	October 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
TD: Experimental thalidomide-dexamethasone	Drug: thalidomide 100 mg/day orally until progression or severe toxicity
ID: Active Comparator Interferon-dexamethasone	Drug: interferon alpha 3 MU 3 times a week until progression or severe toxicity

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633542

Locations

Italy
Clinica di ematologia ospedali riuniti ancona università politecnica delle marche
Ancona, Italy, 60020

Sponsors and Collaborators

Università Politecnica delle Marche

Investigators

Principal Investigator:	Offidani Massimo, MD	clinica di ematologia ospedali riuniti ancona università politecnica delle marche
Study Chair:	Pietro Leoni, MD, PhD	clinica di ematologia università politecnica delle marche

More Information

Publications:

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.

Responsible Party:	Clinica di Ematologia Università Politecnica delle Marche ( Offidani Massimo )
Study ID Numbers:	MO 02/02 MM, AIL 2002
Study First Received:	January 2, 2008
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00633542 History of Changes
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Università Politecnica delle Marche:

thalidomide
maintenance
interferon

dexamethasone
newly diagnosed multiple myeloma
relapsed refractory multiple myeloma

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Thalidomide
Immunologic Factors
Blood Protein Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Anti-Bacterial Agents
Hemorrhagic Disorders
Dexamethasone acetate

Interferon-alpha
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Hematologic Diseases
Blood Coagulation Disorders
Interferons
Vascular Diseases
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors
Glucocorticoids
Doxorubicin
Multiple Myeloma
Peripheral Nervous System Agents
Interferon Alfa-2a

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Thalidomide
Immunologic Factors
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Anti-Bacterial Agents
Hemorrhagic Disorders

Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Dexamethasone acetate
Interferon-alpha
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Growth Substances
Interferons
Gastrointestinal Agents
Vascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009