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Trial record 59 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00633542
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : March 12, 2008
Information provided by:
Università Politecnica delle Marche

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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: thalidomide Drug: interferon alpha Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
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
Study Start Date : June 2003
Actual Primary Completion Date : September 2007
Actual Study Completion Date : October 2007

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. progression free survival [ Time Frame: 3 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00633542

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

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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
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: March 12, 2008
Last Verified: March 2008

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

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