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:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT00008268
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma
* Must have received induction therapy within the past 3 months
* Chemoresponsive disease
* Greater than 50% reduction of monoclonal paraprotein with reduction in marrow plasma cell infiltrate or greater than 50% reduction in marrow plasma cell infiltrate if disease is non-secretory
* No symptomatic pleural effusions
* Eligible for stem cell transplantation
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-3 (ECOG 3 allowed only if due to bone disease or neuropathy)
Life expectancy:
* Not specified
Hematopoietic:
* Platelet count at least 150,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.5 mg/dL
Renal:
* Creatinine no greater than 2.5 mg/dL OR
* Creatinine clearance greater than 51 mL/min
Cardiovascular:
* No symptomatic cardiomyopathy
* No medically documented symptomatic cardiac arrhythmias within the past 60 days
* No New York Heart Association class III congestive heart failure
* No myocardial infarction within the past 6 months
Other:
* No other concurrent medical conditions that would preclude study
* No uncontrolled infections
* No other active malignancy within the past 5 years except for non-melanoma skin cancer
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior stem cell mobilization or transplantation
Chemotherapy:
* See Disease Characteristics
* No more than 200 mg prior oral melphalan
Endocrine therapy:
* Not specified
Radiotherapy:
* No more than 3000 cGy of prior radiotherapy for myeloma
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00008268
Study Brief:
Protocol Section:
NCT00008268