ISRCTN90692740
Completed
Not Applicable
Randomised phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)0 sites420 target enrollmentDecember 20, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
- Enrollment
- 420
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with a confirmed diagnosis of multiple myeloma stage Ib, II or III according to the Salmon \& Durie criteria
- •2\. Age \>65 years
- •3\. WHO performance status 0\-3
- •4\. Measurable tumorparameter (M\-protein or Bence Jones proteïnuria)
- •5\. Written informed consent
Exclusion Criteria
- •1\. Known intolerance to Thalidomide
- •2\. Systemic AL amyloidosis
- •3\. Polyneuropathy
- •4\. Severe cardiac dysfunction (NYHA classification II\-IV)
- •5\. Severe pulmonary dysfunction
- •6\. Significant hepatic dysfunction (serum bilirubin \=30 mmol/l or transaminases \=25 times normal level), unless related to myeloma
- •7\. Renal failure with dependency on dialysis
- •8\. Patients with active, uncontrolled infections
- •9\. Pre\-treatment with cytostatic drug or alpha interferon
- •10\. Patients known to be HIV\-positive
Outcomes
Primary Outcomes
Not specified
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