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


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.

Full Title of Study: “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”

Study Type

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


  • Drug: Thalidomide/Dexamethasone vs Melphalan/Prednisone

Clinical Trial Outcome Measures

Primary Measures

  • Time to progression
  • Response rate

Secondary Measures

  • Survival
  • Time to response
  • Toxicity
  • Quality of life

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Austrian Forum Against Cancer
  • Overall Official(s)
    • Heinz Ludwig, MD,Univ.Prof, Principal Investigator, Wilhelminenspital 1st medical dep.-center for oncology and hematology

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