Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy

November 21, 2013 updated by: Austrian Forum Against Cancer

International, Multi-center, Prospective, Double Randomized, Open Phase III Study Evaluating Thalidomide/Dexamethasone Versus Melphalan/Prednisone as Induction Therapy and Thalidomide/Interferon-alpha Versus Interferon-alpha as Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma

This is an international multi-center prospective, double randomized, open, controlled phase III study with a phase II entrance phase to compare the therapeutic efficacy of thalidomide plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 2
  • 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

  • Austria
      • Vienna, Austria, 1190
        • Wilhelminenspital, 1st Medical Department-center for oncology and hematology

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Multiple Myeloma of IgG, IgA, IgD, IgE, IgM lambda or kappa light chain, low secretory or non-secretory disease
  • WHO performance status 0,1,2,or 3
  • No prior treatment of multiple myeloma
  • Clear requirement of treatment (usually Durie/Salmon stage II or III)
  • Anticipated life expectancy of at least 3 months
  • Adequate organ function
  • Minimum recovery period of 2 weeks following any major surgical procedure before entry into this study
  • Women, who are sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal
  • Age of at least 19 years, there is no upper age limit patients must have been informed and must have signed an informed consent

Exclusion Criteria:

  • Extramedullary plasmocytoma or solitary plasmocytoma without evidence of dissemination of disease
  • Benign monoclonal gammopathy
  • Multiple myeloma of IgM without osteolytic bone lesions
  • Smouldering myeloma
  • More than 3 irradiation fields
  • Irreversible performance status of WHO4
  • Prior treatment of myeloma with any of the following: chemotherapeutic or immunomodulatory agents, corticosteroids, antiangiogenic agents or other investigational drugs
  • Women of childbearing potential
  • Preexisting peripheral polyneuropathy
  • Congestive heart failure NYHA III, IV
  • Acute infection requiring systemic antibiotics at study entry until resolved
  • Any uncontrolled underlying medical condition (eg diabetes, glaucoma)
  • Second primary malignancy (with the exception of cervical carcinoma in situ and non-myeloma skin malignancies) unless patient has been disease-free for at least three years

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to progression
Response rate

Secondary Outcome Measures

Outcome Measure
Toxicity
Quality of life
Survival
Time to response

Collaborators and Investigators

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

Sponsor

Austrian Forum Against Cancer

Investigators

  • Principal Investigator: Heinz Ludwig, MD,Univ.Prof, Wilhelminenspital 1st medical dep.-center for oncology and hematology

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

August 1, 2001

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-002-0601

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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