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

This study has been completed.
Information provided by:
Università Politecnica delle Marche Identifier:
First received: January 2, 2008
Last updated: March 4, 2008
Last verified: March 2008
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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • overall survival safety [ Time Frame: 3 years ]

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
Drug: thalidomide
100 mg/day orally until progression or severe toxicity
Active Comparator: ID
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00633542

Clinica di ematologia ospedali riuniti ancona università politecnica delle marche
Ancona, Italy, 60020
Sponsors and Collaborators
Università Politecnica delle Marche
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

Responsible Party: Offidani Massimo, Clinica di Ematologia Università Politecnica delle Marche 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

Keywords provided by Università Politecnica delle Marche:
newly diagnosed multiple myeloma
relapsed refractory multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Liposomal doxorubicin
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 20, 2017