Multiple myeloma.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: At entry: 1. Previously untreated multiple myeloma, stage 2 or 3 according to Salmon and Durie; 2. Age 50x10^9/l; 12. Absolute neutrophil count > 1x10^9/l; 13. Informed consent.
Exclusion criteria
Exclusion criteria: At entry: 1. Received more than 2 courses of melphalan, prednisone or VMCP; 2. Severe cardiac disease (= severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45% with presence of normal hemoglobin), severe pulmonary, neurologic or metabolic disease- Inadequate liver function, i.e. bilirubin >=2.5x upper normal value; 3. Prior malignancies except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma; 4. Prior extensive radiotherapy involving the myelum (precluding total body irradiation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Event-free survival; 2. Overall survival; 3. Quality of life; 4. Cost-benefit. | — |
Contacts
University Medical Center Utrecht (UMCU), Department of Hematology (B02.226), P.O. Box 85500