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 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT00007995
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed multiple myeloma OR
* Primary systemic amyloidosis resulting in significant organ dysfunction and decreased quality of life
* Complete or partial response after standard chemotherapy
* Primary refractory or relapsed multiple myeloma after first-line treatment with standard chemotherapy
* Ineligible for higher priority national or institutional clinical studies
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin less than 2 times normal
Renal:
* Creatinine less than 2.5 mg/dL or on stable hemodialysis
Cardiovascular:
* LVEF at least 45%
Pulmonary:
* DLCO at least 60% of predicted OR
* Approval by pulmonologist
Other:
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Concurrent participation in gene therapy trials allowed
Chemotherapy:
* See Disease Characteristics
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent steroids as antiemetics during chemotherapy
* No concurrent anticancer hormonal therapy
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No concurrent barbiturates or acetaminophen during chemotherapy
* Concurrent participation in supportive care trials allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00007995
Study Brief:
Protocol Section:
NCT00007995