Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma - Article
Clinical Trial: Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma
This study is no longer recruiting patients.
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.
|Condition||Treatment or Intervention||Phase|
|refractory plasma cell neoplasm |
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
| Drug: cyclophosphamide |
Procedure: endocrine therapy
Procedure: hormone therapy
Procedure: steroid therapy
|Phase III |
MedlinePlus related topics: Immune System and Disorders; Lymphatic Diseases; Multiple Myeloma
Study Type: Interventional
Study Design: Treatment
- 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.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- 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
- 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 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
- At least 3 months since prior chemotherapy
- Not specified
- Not specified
- No prior participation in any clinical trial with an unlicensed product
United Kingdom, England
Hammersmith Hospital, London, England, W12 ONN, United Kingdom
Diana Samson, MD, Study Chair, Hammersmith Hospital
Record last reviewed: June 2003
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003603
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005