We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00633542
First Posted: March 12, 2008
Last Update Posted: March 12, 2008
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.
Information provided by:
Università Politecnica delle Marche
  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
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
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 2, 2008
First Posted: March 12, 2008
Last Update Posted: March 12, 2008
Last Verified: March 2008

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
Dexamethasone acetate
Dexamethasone
Liposomal doxorubicin
Interferons
Thalidomide
BB 1101
Interferon-alpha
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists