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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT00005834
Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage I, II, or III multiple myeloma with protein criteria present Quantifiable M-components of IgG, IgA, IgD, IgE AND/OR Urinary kappa or lambda light chain excretion No IgM peaks Quantifiable monoclonal proteins Received at least 1, but no more than 4 prior treatment regimens, including the following: Chemotherapy Bone marrow transplantation Biologic therapy Radiotherapy Interferon therapy or steroid pulsing given as maintenance therapy after transplantation or chemotherapy is not considered a separate treatment regimen Progressive disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 (3-4 allowed if due solely to bone pain) Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,000/mm3 Platelet count at least 50,000/mm3 (at least 50% plasma cells in bone marrow) Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 methods of effective contraception for 4 weeks before, during, and for 4 weeks after study No other prior or concurrent malignancies within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or II cancer in complete remission No grade 2 or greater preexisting peripheral neuropathy
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior thalidomide allowed if received less than 3 months of therapy Recovered from prior biologic therapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal therapy Radiotherapy: See Disease Characteristics At least 3 weeks since prior extensive or limited radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00005834
Study Brief:
Protocol Section:
NCT00005834