Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma and Plasma Cell Neoplasm
Intervention: cyclophosphamide (Drug); dexamethasone (Drug); idarubicin (Drug); lomustine (Drug); melphalan (Drug); prednisolone (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Riverside Haematology Group
Official(s) and/or principal investigator(s):
Diana Samson, MD, Study Chair, Affiliation: Hammersmith Hospital
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells.
Steroids, such as dexamethasone or prednisolone, may help relieve some of the side effects of
chemotherapy. It is not yet known which regimen of chemotherapy plus steroid therapy is more
effective in treating patients with multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of
chemotherapy plus steroid therapy in treating patients with multiple myeloma that has
recurred for the first time.
Official title: A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) With Melphalan and Prednisolone in Relapsed Multiple Myeloma
Study design: Treatment, Randomized, Active Control
- 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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- No primary refractory disease or second or later relapse
- 18 and over
- Not specified
- Neutrophil count at least 1,000/mm^3
- Platelet count at least 75,000/mm^3
- Bilirubin no greater than 1. 5 times upper limit of normal (ULN)
- ALT/AST no greater than 2. 5 times ULN
- Creatinine less than 3. 4 mg/dL
- No clinically significant cardiac insufficiency
- No uncontrolled hypertension
- 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
PRIOR CONCURRENT THERAPY:
- No prior allogeneic peripheral blood stem cell or bone marrow transplantation
- No planned future autologous transplantation unless sufficient stored stem cells
- Prior interferon allowed if administered as maintenance of stable plateau phase
- No concurrent epoetin alfa
- At least 3 months since prior chemotherapy
- Not specified
- Concurrent radiotherapy for pain or to treat localized tumors allowed
- Not specified
- No prior participation in any clinical trial with an unlicensed product
Locations and Contacts
Hammersmith Hospital, London, England W12 ONN, United Kingdom
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 1998
Last updated: May 23, 2008