Thalidomide for Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring myeloma
Eligibility Criteria
Previously untreated patients with multiple myeloma and without serious or imminent complications (e.g. impending pathologic fracture, hypercalcemia, renal insufficiency). All asymptomatic patients with low or intermediate tumor mass will qualify. Patients with high tumor mass, symptomatic or impending fractures, hypercalcemia (corrected calcium >11.5 mg%), anemia (Hgb <8.5 gm/dl), renal failure (creatinine >2.0 mg/dl), high serum lactate dehydrogenase (>300 U/L) or plasma cell leukemia (>1000/ul) are ineligible. Overt infections or unexplained fever should be resolved before treatment. Adequate liver function (including SGPT, bilirubin and LDH) is required. Patients must have Zubrod performance of 1 or less. Patients must provide written informed consent indicating that they are aware of the investigational nature of this study. Life expectancy should exceed 1 year. Patients with idiopathic monoclonal gammopathy and non-secretory multiple myeloma are ineligible. Patients whose only prior therapy has been with local radiotherapy, alpha-IFN, or ATRA are eligible. Patients exposed to prior high-dose glucocorticoid or alkylating agent are not eligible.
Sites / Locations
- University of Texas M. D. Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Thalidomide
200 mg at bedtime daily for 14 days (days 1-14), followed by an increase to 400 mg daily for 14 days (days 15-28), 600 mg daily for 14 days (days 29-42), up to a maximum 800 mg (days 43-completion)