Main info

Identificatie:

HOVON 49 MM

Sponsor:

HOVON

Included patients:

344

Active sites:

0

(of 53)

Title:

Randomized phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone.

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Patients with a confirmed diagnosis of multiple myeloma stage Ib, II or III according to the Salmon & Durie criteria (Appendix A)
• Age > 65 years
• WHO performance status 0-3 (see appendix D)
• Measurable tumorparameter (M-protein or Bence Jones prote﮵ria)
• Written informed consent.

Exclusion Criteria:

• Known intolerance to Thalidomide
• Systemic AL amyloidosis
• Polyneuropathy
• Severe cardiac dysfunction (NYHA classification II-IV, appendix E)
• Severe pulmonary dysfunction
• Significant hepatic dysfunction (total bilirubin >= 30 umol/l or transaminases >= 2.5 times normal level), unless related to myeloma
• Renal failure with dependency on dialysis
• Patients with active, uncontrolled infections
• Pre-treatment with cytostatic drug or alpha interferon
• Patients known to be HIV-positive
• History of active malignancy during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma