A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) With Melphalan and Prednisolone in Relapsed Multiple Myeloma
- Compare the response rate, response duration, and survival of patients with relapsed
multiple myeloma after treatment with lomustine, idarubicin, and dexamethasone vs
melphalan and prednisolone.
OUTLINE: This is a randomized study. Patients are stratified according to prior autologous
transplant (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral lomustine on day 1, oral idarubicin once daily on days
1-3, and oral dexamethasone twice a day on days 1-4. Treatment is repeated every 28
days for 6-9 courses in the absence of unacceptable toxicity or disease progression.
- Arm II: Patients receive oral melphalan once daily on days 1-4 and oral prednisolone
twice a day on days 1-4. Treatment is repeated every 28 days for 6-9 courses in the
absence of unacceptable toxicity or disease progression.
Some patients may receive oral cyclophosphamide every 7 days and oral prednisolone on
alternate days for 6 weeks concurrently with chemotherapy in either treatment arm.
Quality of life is assessed at baseline, at 3, 6, 9, and 12 months, and then every 6 months
Patients are followed until death.
PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study within 5 years.
Allocation: Randomized, Primary Purpose: Treatment
Diana Samson, MD
United States: Federal Government