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

This study has been completed.
Sponsor:
Information provided by:
Università Politecnica delle Marche
ClinicalTrials.gov Identifier:
NCT00633542
First received: January 2, 2008
Last updated: March 4, 2008
Last verified: March 2008
  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 3

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


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
Experimental: TD
thalidomide-dexamethasone
Drug: thalidomide
100 mg/day orally until progression or severe toxicity
Active Comparator: ID
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Offidani Massimo, Clinica di Ematologia Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT00633542     History of Changes
Other Study ID Numbers: MO 02/02 MM, AIL 2002
Study First Received: January 2, 2008
Last Updated: March 4, 2008
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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons
Thalidomide
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on July 22, 2014