A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) With Melphalan and Prednisolone in Relapsed Multiple Myeloma
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) With Melphalan and Prednisolone in Relapsed Multiple Myeloma
OBJECTIVES:
- 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
thereafter.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study within 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma based on at least two of the following:
- Paraprotein in serum and/or urine
- Greater than 10% plasma cells in bone marrow
- Lytic bone lesions
- Measurable serum and/or urine paraprotein
- Progression from first or second stable plateau phase
- No non-secretory myeloma or plasma cell leukemia (greater than 2,000/mm^3 circulating
plasma cells)
- No primary refractory disease or second or later relapse
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- 0-3
Life expectancy:
- Not specified
Hematopoietic:
- Neutrophil count at least 1,000/mm^3
- Platelet count at least 75,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT/AST no greater than 2.5 times ULN
Renal:
- Creatinine less than 3.4 mg/dL
Cardiovascular:
- No clinically significant cardiac insufficiency
- No uncontrolled hypertension
Other:
- No uncontrolled diabetes mellitus
- No recent history of peptic ulceration
- HIV-1 and HIV-2 negative
- Fertile patients must use effective contraception during and for 6 months after study
participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior allogeneic peripheral blood stem cell or bone marrow transplantation
- No planned future autologous transplantation unless sufficient stored stem cells
available
- Prior interferon allowed if administered as maintenance of stable plateau phase
- No concurrent epoetin alfa
Chemotherapy:
- At least 3 months since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Concurrent radiotherapy for pain or to treat localized tumors allowed
Surgery:
- Not specified
Other:
- No prior participation in any clinical trial with an unlicensed product
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Diana Samson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hammersmith Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000066676
NCT ID:
NCT00003603
Start Date:
March 1998
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- refractory multiple myeloma
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
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