Status:
COMPLETED
Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy
Lead Sponsor:
Austrian Forum Against Cancer
Conditions:
Multiple Myeloma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
PHASE3
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 dexamethas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00205751
Start Date
August 1 2001
End Date
October 1 2009
Last Update
November 25 2013
Active Locations (1)
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1
Wilhelminenspital, 1st Medical Department-center for oncology and hematology
Vienna, Austria, 1190