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 @ 1:13 PM
Ignite Modification Date:
2025-12-24 @ 1:13 PM
NCT ID:
NCT00482495
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of relapsed or refractory multiple myeloma
* Measurable or evaluable disease as defined by ≥ 1 of the following:
* 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)
* No concurrent amyloidosis
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0 or 1
* ECOG PS 2 based on immobility from myeloma bone disease alone allowed at the discretion of treating physician
* Creatinine ≤ 2.0 mg/dL
* ANC ≥ 1,000/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin ≥ 8.0 g/dL
* Proteinuria ≤ 1 g/dL by 24-hour urine collection (excluding monoclonal protein)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
* No bleeding diathesis
* No hypertension (defined as BP \> 150/100 mm Hg)
* No active bleeding, healing or nonhealing wound, ulcer, or bone fracture (excluding fractures secondary to myeloma)
* No active ulcerative disease including, but not limited to, any of the following:
* Peptic ulcer disease
* Ulcerative esophagitis
* Ulcerative colitis
* Crohn's disease
* LVEF ≥ 50% by 2-dimensional ECHO or MUGA scan
* No NYHA class III or IV heart disease
* No other active malignancy except for nonmelanoma skin cancer or in situ cervical or breast cancer
* No active infection
* No other comorbidity that would interfere with study compliance
* No transient ischemic attack, cerebrovascular accident, or myocardial infarction within the past year
* No abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within the past 6 months
* No significant traumatic injury within the past 28 days
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No more than 2 prior antimyeloma treatment courses, except for bisphosphonates
* No standard or experimental drug therapy, other than ongoing bisphosphonate treatment and/or epoetin alfa, within the past 28 days
* No experimental non-drug therapy within the past 28 days
* Palliative radiation therapy within the past 28 days allowed provided ≤ 3 sites of bone disease was irradiated
* No prior bevacizumab or other experimental antiangiogenic agents other than thalidomide or lenalidomide
* No minor surgical procedures, fine-needle aspiration, or core biopsies within the past 7 days
* No major surgical procedure or open biopsy within the past 28 days
* No concurrent corticosteroids
* Chronic steroids ≤ 20 mg/day (prednisone equivalent) for disorders other than myeloma (i.e., adrenal insufficiency, rheumatoid arthritis) allowed
* No other concurrent investigational therapy
* No other concurrent systemic antineoplastic therapy including, but not limited to, the following:
* Cytotoxic chemotherapy
* Immunotherapy
* Hormonal therapy
* Monoclonal antibody therapy
* Concurrent bisphosphonates allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00482495
Study Brief:
Protocol Section:
NCT00482495