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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT00033332
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Newly diagnosed symptomatic multiple myeloma confirmed by the following:
* Bone marrow plasmacytosis with at least 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytosis
* Monoclonal protein (M protein) at least 1.0 g/dL on serum protein electrophoresis or at least 200 mg of monoclonal light chain on a 24-hour urine protein electrophoresis
* No smoldering myeloma or monoclonal gammopathy of undetermined significance
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 50,000/mm\^3
* Hemoglobin greater than 7 g/dL
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* ALT and AST no greater than 2.5 times upper limit of normal
Renal:
* Creatinine less than 3 mg/dL
Cardiovascular:
* No prior or concurrent deep venous thrombosis
Other:
* Prior malignancy allowed provided the following criteria are met:
* Received prior treatment with curative intent
* Free of disease for the time period appropriate for cure of the specific cancer
* No grade 2 or greater peripheral neuropathy due to other medical conditions
* No active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 1 highly effective method and 1 additional method of contraception for 1 month before, during, and for 4 weeks after study for women and effective barrier contraception for men during and for 4 weeks after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic therapy for multiple myeloma
* No other concurrent biologic therapy for multiple myeloma
Chemotherapy:
* No prior chemotherapy for multiple myeloma
* No other concurrent chemotherapy for multiple myeloma
Endocrine therapy:
* More than 6 months since prior systemic dexamethasone or glucocorticoids
* No concurrent corticosteroids
Radiotherapy:
* At least 4 weeks since prior palliative, localized radiotherapy
* Concurrent palliative, localized radiotherapy allowed at the physician's discretion
Surgery:
* Not specified
Other:
* No prior systemic therapy for multiple myeloma, except bisphosphonates
* No concurrent anticoagulant therapy for deep vein thrombosis
* No concurrent barbiturates or alcohol (thalidomide arm)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00033332
Study Brief:
Protocol Section:
NCT00033332