Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT00038233
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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00038233
Study Brief:
Protocol Section:
NCT00038233