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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT00432458
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma (MM)
* Previously untreated asymptomatic disease
* No requirement for immediate chemotherapy for active MM, such as hypercalcemia from myeloma or painful bone lesions
* No solitary plasmacytoma
* Measurable or evaluable disease as defined by one of the following:
* Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
* More than 200 mg of monoclonal protein in the urine by 24-hour electrophoresis
* Measurable soft tissue plasmacytoma by physical exam with ruler or by MRI or positron emission tomography/CT scan
* If the only measurable lesion is the plasmacytoma, it must be ≥ 1.5 cm in 1 dimension
* Must have ≥ 10% plasma cells as measured on the bone marrow aspirate, bone marrow biopsy, or labeling index
* No amyloidosis
PATIENT CHARACTERISTICS:
* Performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 8.0 g/dL
* Creatinine ≤ 2.0 mg/dL (elevation above normal range should not be felt to be related to myeloma)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 4 weeks after completion of study treatment
* No uncontrolled infection
* No other active malignancy
* No New York Heart Association class III or IV heart disease
* No pre-existing neuropathy ≥ grade 2
* No concurrent major dental work
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Prior corticosteroids (for nonmalignant disorders) allowed
* Prior therapy with experimental agents not shown to have significant activity in MM, such as clarithromycin, dehydroepiandrosterone, and anakinra allowed
* No prior thalidomide or corticosteroids for MM
* No more than 3 doses of IV zoledronate or pamidronate within the past 12 months
* At least 3 months since prior radiotherapy, including radiotherapy for solitary plasmacytoma
* No concurrent oral bisphosphonate therapy for osteoporosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00432458
Study Brief:
Protocol Section:
NCT00432458