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

March 4, 2008 updated by: Università Politecnica delle Marche

Thalidomide-Dexamethasone vs Alpha-Interferon-Dexamethasone as Maintenance Therapy After Thalidomide, Dexamethasone and Pegylated Liposomal Doxorubicin Combination for

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival safety
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

January 2, 2008

First Submitted That Met QC Criteria

March 4, 2008

First Posted (Estimate)

March 12, 2008

Study Record Updates

Last Update Posted (Estimate)

March 12, 2008

Last Update Submitted That Met QC Criteria

March 4, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO 02/02 MM
  • AIL 2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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