Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy
Phase 2
Completed
- Conditions
- Multiple Myeloma
- Registration Number
- NCT00205751
- Lead Sponsor
- Austrian Forum Against Cancer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to progression Response rate
- Secondary Outcome Measures
Name Time Method Toxicity Survival Time to response Quality of life
Trial Locations
- Locations (1)
Wilhelminenspital, 1st Medical Department-center for oncology and hematology
🇦🇹Vienna, Austria