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 @ 4:40 AM
Ignite Modification Date:
2025-12-25 @ 4:40 AM
NCT ID:
NCT00478218
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma
* Newly diagnosed disease
* Symptomatic disease
* Measurable or evaluable disease, defined by ≥ 1 of the following criteria:
* Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
* Monoclonal protein \> 200 mg by 24-hour urine electrophoresis
* Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
* Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
* Measurable soft tissue plasmacytoma not previously irradiated
* No monoclonal gammopathy of undetermined significance or smoldering myeloma
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-2 (ECOG PS 3 allowed if secondary to pain)
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Hemoglobin ≥ 8.0 g/dL
* Creatinine ≤ 2.5 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for 1 month before, during, and for 4 weeks after completion of study therapy
* No uncontrolled infection
* No other active malignancy
* No other malignancies within the past 5 years except for currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
* No NYHA class III-IV congestive heart failure
* No untreated active deep vein thrombosis
PRIOR CONCURRENT THERAPY:
* At least 3 weeks since prior radiotherapy for solitary plasmacytoma
* Prior clarithromycin, therapeutic dehydroepiandrosterone (DHEA), anakinra, pamidronate disodium, or zoledronic acid allowed
* No prior cytotoxic chemotherapy
* No prior corticosteroids (except for treatment of a nonmalignant disorder)
* Concurrent corticosteroids (prednisone ≤ 20 mg/per day) allowed
* No concurrent radiotherapy except palliative radiotherapy for a single painful bone lesion or fracture
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00478218
Study Brief:
Protocol Section:
NCT00478218