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 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT00006466
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven myeloma
* Multiple myeloma
* Indolent myeloma with slowly progressive bone pathology
* Smoldering myeloma with no bone pathology but a progressive increase in M-protein
* Solitary myeloma OR
* Diagnosis of evolving monoclonal gammopathy of undetermined significance with increasing M-protein or decreasing hemoglobin level
* Measurable M-protein or Bence Jones protein
* Indolent disease not requiring therapy allowed
* No clinical signs or evidence of active brain involvement or leptomeningeal disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 50-100%
Life expectancy:
* At least 4 months
Hematopoietic:
* See Disease Characteristics
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* Bilirubin less than 2.0 mg/dL
* Transaminases no greater than 2.5 times upper limit of normal
Renal:
* Creatinine no greater than 2.0 mg/dL
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No acute changes on electrocardiogram
* No uncontrolled angina, heart failure, or arrhythmia
Other:
* Adequate nutritional status (total protein at least 60.0 g/L, albumin at least 35 g/L)
* HIV negative
* No AIDS
* No active bacterial infection (e.g., abscess) or with fistula
* No history of alcoholism, drug addiction, or psychotic disorders that would preclude study
* No other nonmalignant disease that would preclude study
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy or cytokines
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high-dose carboplatin)
Endocrine therapy:
* No concurrent corticosteroids
Radiotherapy:
* No prior radiotherapy to greater than 25% of bone marrow
Surgery:
* Recovered from any prior surgery
* No prior solid organ transplantation
Other:
* No other concurrent investigational agent
* No concurrent immunosuppressive agents
* No concurrent anti-inflammatory agents, including aspirin or over-the-counter or prescription nonsteroidal anti-inflammatory drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006466
Study Brief:
Protocol Section:
NCT00006466