©2024 Stanford Medicine
Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
Not Recruiting
Trial ID: NCT00033332
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow
to the tumor. Combining dexamethasone and thalidomide may kill more cancer cells. It is not
yet known whether dexamethasone is more effective with or without thalidomide in treating
multiple myeloma.
PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or
without thalidomide in treating patients who have multiple myeloma.
Official Title
A Randomized Phase III Trial Of Thalidomide (NSC # 66847) Plus Dexamethasone Versus Dexamethasone In Newly Diagnosed Multiple Myeloma
Stanford Investigator(s)
Anand Veeravagu
Associate Professor of Neurosurgery and, by courtesy, of Orthopaedic Surgery
Eligibility
DISEASE CHARACTERISTICS:
- Newly diagnosed symptomatic multiple myeloma confirmed by the following:
- Bone marrow plasmacytosis with at least 10% plasma cells or sheets of plasma
cells or biopsy-proven plasmacytosis
- Monoclonal protein (M protein) at least 1.0 g/dL on serum protein electrophoresis
or at least 200 mg of monoclonal light chain on a 24-hour urine protein
electrophoresis
- No smoldering myeloma or monoclonal gammopathy of undetermined significance
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 50,000/mm^3
- Hemoglobin greater than 7 g/dL
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- ALT and AST no greater than 2.5 times upper limit of normal
Renal:
- Creatinine less than 3 mg/dL
Cardiovascular:
- No prior or concurrent deep venous thrombosis
Other:
- Prior malignancy allowed provided the following criteria are met:
- Received prior treatment with curative intent
- Free of disease for the time period appropriate for cure of the specific cancer
- No grade 2 or greater peripheral neuropathy due to other medical conditions
- No active infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 1 highly effective method and 1 additional method of
contraception for 1 month before, during, and for 4 weeks after study for women and
effective barrier contraception for men during and for 4 weeks after study
participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy for multiple myeloma
- No other concurrent biologic therapy for multiple myeloma
Chemotherapy:
- No prior chemotherapy for multiple myeloma
- No other concurrent chemotherapy for multiple myeloma
Endocrine therapy:
- More than 6 months since prior systemic dexamethasone or glucocorticoids
- No concurrent corticosteroids
Radiotherapy:
- At least 4 weeks since prior palliative, localized radiotherapy
- Concurrent palliative, localized radiotherapy allowed at the physician's discretion
Surgery:
- Not specified
Other:
- No prior systemic therapy for multiple myeloma, except bisphosphonates
- No concurrent anticoagulant therapy for deep vein thrombosis
- No concurrent barbiturates or alcohol (thalidomide arm)
Intervention(s):
drug: dexamethasone
drug: pamidronate disodium
drug: thalidomide
drug: zoledronic acid
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305