- Confirmed diagnosis of multiple myeloma.
- Patients must have a minimum serum M-protein level >=10g/L on serum protein
electrophoresis or for patients with light chain only disease, a minimum Bence-Jones
protein of 1g/24 hr.
- Patients must have received prior treatment for multiple myeloma: patients may have
received 1 or 2 prior regimens of oral alkylating based chemotherapy and must have
relapsed following treatment (>= 3 months) OR patients may have relapsed following
high dose chemotherapy and SCT as first line treatment provided they have not had any
- Lab at inclusion of AGC >= 1.0 x10_9/L and platelets >= 50 x10_9/L Bilirubin, AST
and/or ALT <= 1.5 x UNL; creatinine < 2 x UNL, Potassium >= 4.0 mmol/L; calcium and
magnesium within normal limits·
- Patients may not have had > 2 prior regimens of chemotherapy and/or prior thalidomide
- Patients may not have had any non-alkylating based chemotherapy.
- Patients with a history of other malignancies, except: adequately treated
non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other
solid tumours curatively treated with no evidence of disease for >= 5 years.
- Pregnant or lactating women. Women of childbearing potential must have a negative
pregnancy test within 7 days prior to registration and must be using effective
contraception throughout the study.
- Patients who have relapsed during treatment with oral alkylating chemotherapy.
- Patients who have received more than 2 prior regimens of chemotherapy.
- Patients who have received excluded medication or have excluded medical conditions.
- Patients who have received any non-alkylating based chemotherapy regimens as initial
therapy, or as therapy for recurrent disease.