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
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