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 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT00003603
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma based on at least two of the following:
* Paraprotein in serum and/or urine
* Greater than 10% plasma cells in bone marrow
* Lytic bone lesions
* Measurable serum and/or urine paraprotein
* Progression from first or second stable plateau phase
* No non-secretory myeloma or plasma cell leukemia (greater than 2,000/mm\^3 circulating plasma cells)
* No primary refractory disease or second or later relapse
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* 0-3
Life expectancy:
* Not specified
Hematopoietic:
* Neutrophil count at least 1,000/mm\^3
* Platelet count at least 75,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT/AST no greater than 2.5 times ULN
Renal:
* Creatinine less than 3.4 mg/dL
Cardiovascular:
* No clinically significant cardiac insufficiency
* No uncontrolled hypertension
Other:
* No uncontrolled diabetes mellitus
* No recent history of peptic ulceration
* HIV-1 and HIV-2 negative
* Fertile patients must use effective contraception during and for 6 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior allogeneic peripheral blood stem cell or bone marrow transplantation
* No planned future autologous transplantation unless sufficient stored stem cells available
* Prior interferon allowed if administered as maintenance of stable plateau phase
* No concurrent epoetin alfa
Chemotherapy:
* At least 3 months since prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Concurrent radiotherapy for pain or to treat localized tumors allowed
Surgery:
* Not specified
Other:
* No prior participation in any clinical trial with an unlicensed product
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003603
Study Brief:
Protocol Section:
NCT00003603