Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Austrian Forum Against Cancer
ClinicalTrials.gov Identifier:
NCT00205751
First received: September 12, 2005
Last updated: July 22, 2010
Last verified: July 2010
History of Changes

September 12, 2005
July 22, 2010
August 2001
Not Provided
  • Time to progression
  • Response rate
Same as current
Complete list of historical versions of study NCT00205751 on ClinicalTrials.gov Archive Site
  • Survival
  • Time to response
  • Toxicity
  • Quality of life
Same as current
Not Provided
Not Provided
 
Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: Thalidomide/Dexamethasone vs Melphalan/Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
October 2009
Not Provided

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00205751
01-002-0601
Not Provided
Not Provided
Austrian Forum Against Cancer
Not Provided
Principal Investigator: Heinz Ludwig, MD,Univ.Prof Wilhelminenspital 1st medical dep.-center for oncology and hematology
Austrian Forum Against Cancer
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP