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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT00079456
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of multiple myeloma (MM)
* Salmon-Durie stage IIA or IIIA OR progressive stage IA disease
* Meets at least 1 major AND 1 minor criterion OR at least 3 minor criteria
* The following are considered major criteria:
* Plasmacytoma on tissue biopsy
* Bone marrow plasmacytosis with \>= 30% plasma cells
* Monoclonal globulin spike on serum protein electrophoresis exceeding 3.5 g/dL for immunoglobulin (Ig) G peaks or 2.0 g/dL for IgA peaks OR the presence of Bence-Jones protein of \>= 1 g/24 hour-urine collection
* The following are considered minor criteria:
* Bone marrow plasmacytosis 10-29%
* Monoclonal globulin spike present, but less than the levels defined for a major criterion
* Lytic bone lesion
* Decrease in normal IgM \< 50 mg/dL, IgA \< 100 mg/dL, or IgG \< 600 mg/dL
* No non-secretory MM (absent serum or urinary M-protein)
* Failed at least 1 prior systemic therapy\* (e.g., chemotherapy, high-dose corticosteroids, thalidomide, or bortezomib) for the treatment of MM
* No solitary plasmacytoma
* Performance status - ECOG 0-2
* More than 6 months
* Absolute neutrophil count \> 1,200/mm\^3
* Platelet count \> 75,000/mm\^3
* AST and ALT =\< 2.5 times upper limit of normal (ULN)
* Bilirubin =\< 1.5 times ULN
* Creatinine =\< 1.5 times ULN
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Fasting cholesterol =\< 350 mg/dL
* Triglycerides =\< 400 mg/dL
* No other concurrent uncontrolled illness
* No active or ongoing infection requiring oral or IV antibiotics
* No prior allergic reaction to compounds of similar chemical or biological composition to CCI-779
* No other prior or concurrent malignancy or myelodysplasia except for the following:
* Basal cell or squamous cell skin cancer
* Carcinoma in situ of the cervix
* Localized cancer treated with surgery only with no evidence of disease for \> 5 years
* No psychiatric illness or social situation that would preclude study compliance
* More than 4 weeks since prior thalidomide and recovered
* Prior high-dose chemotherapy and stem cell transplantation allowed
* More than 4 weeks since prior chemotherapy and recovered
* More than 4 weeks since prior high-dose corticosteroids and recovered
* More than 4 weeks since prior bortezomib and recovered
* More than 4 weeks since other prior anti-myeloma systemic therapy and recovered
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00079456
Study Brief:
Protocol Section:
NCT00079456