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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT00616720
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma
* Plateau phase multiple myeloma (status post chemotherapy or status post-peripheral blood cell transplantation), meeting the following criteria:
* Serum and urine monoclonal (M) protein values must be stable (\< 20% variation) or must have disappeared
* Serum M protein \< 1 g/dL, and 1 of the following:
* Quantifiable serum M protein
* Adequate serum sample stored in Transfusion Medicine under IRB protocol #698-98
* Urine M protein \< 200 mg/24 hours by electrophoresis on 2 separate occasions for a period of ≥ 4 weeks
* Serum M protein spike ≤ 2.0 g/dL
* No progressive disease after prior autologous stem cell transplantation or chemotherapy
* No non-secretory or light chain myeloma
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 6 months
* WBC ≥ 1,500/μL
* Platelet count ≥ 50,000/μL
* Total bilirubin ≤ 5 times upper limit of normal
* Creatinine ≤ 5.0 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must have adequate venous access for apheresis
* No uncontrolled cardiac disease
* No uncontrolled infection
* No illness or condition which, in the opinion of the investigator, may affect safety of treatment or evaluation of any of the study's endpoints
PRIOR CONCURRENT THERAPY:
* Recovered from all prior therapy
* More than 4 weeks since prior standard-dose chemotherapy, radiotherapy, or immunotherapy
* More than 3 months since prior high-dose chemotherapy with stem cell transplantation
* No concurrent corticosteroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00616720
Study Brief:
Protocol Section:
NCT00616720