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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT00060203
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Confirmed diagnosis of multiple myeloma based on prior or current demonstration of the following criteria\*:
* Major criteria:
* Plasmacytoma on tissue biopsy
* Bone marrow plasmacytosis with at least 30% plasma cells
* Monoclonal globulin spike on serum electrophoresis exceeding 3.5 g/dL for IgG peaks or 2.0 g/dL for IgA peaks; greater than 1,000 mg/24hr of kappa or gamma light chain excretion on urine electrophoresis in the absence of amyloidosis
* Minor criteria:
* Bone marrow plasmacytosis with 10% to 30% plasma cells
* Monoclonal globulin spike present but less than levels in major criterion III above
* Lytic bone lesions
* Residual normal immunoglobulin M (IgM) no greater than 0.5 g/dL, IgA no greater than 0.1 g/dL, or IgG no greater than 0.6 g/dL NOTE: \*Diagnosis of multiple myeloma requires a minimum of 1 major and 1 minor criterion (I and a together is not sufficient; must be I and b, I and c, I and d; II and b, II and c, II and d; III and a, III and c, III and d) or 3 minor criteria that must include a and b (a, b, and c; a, b, and d)
* Measurable disease defined by 1 of the following values:
* Serum myeloma (M) protein (IgG or IgA) level greater than 1.0 g/dL
* Urine M protein (light chain disease) at least 300 mg/24hr
* Soft tissue plasmacytoma with bidimensional measurement at least 20 x 20 mm (10 x 10 mm if spiral CT scan is used)
* Must have progressed during or within 12 months of discontinuing prior myelosuppressive chemotherapy (e.g., vincristine, doxorubicin, and dexamethasone (VAD) or melphalan) OR not responded after 2 courses of prior myelosuppressive chemotherapy
* No indolent or smoldering myeloma or localized plasmacytoma
* No known brain or leptomeningeal disease unless such lesions were previously irradiated, are currently not being treated with corticosteroids, and are associated with no clinical symptoms
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3 (at least 1,000/mm\^3 if neutropenia due to replacement of the normal bone marrow cells by myeloma cells)
* Platelet count at least 100,000/mm\^3 (at least 50,000/mm\^3 if thrombocytopenia due to replacement of the normal bone marrow cells by myeloma cells)
* Hemoglobin at least 8.0 g/dL (no transfusion allowed)
* No hyperviscosity syndrome
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
Renal
* Creatinine no greater than 3.0 times ULN
* Calcium no greater than 12 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and sampling for study analysis
* HIV negative
* No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
* No AIDS-related illness
* No active infectious process or other severe concurrent disease that would make the patient inappropriate for study entry
* No mental incapacity or psychiatric illness that would preclude giving informed consent or completing follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Chemotherapy
* No concurrent anticancer biological response modifiers
* No concurrent immunotherapy
* No concurrent sargramostim (GM-CSF)
Chemotherapy
* See Disease Characteristics
* More than 2 years since prior high-dose chemotherapy with autologous bone marrow transplantation or stem cell support
* More than 4 weeks since prior myelosuppressive chemotherapy
* No other concurrent anticancer chemotherapy
Endocrine therapy
* See Disease Characteristics
* No concurrent anticancer hormonal therapy
* No concurrent chronic steroids
* Acute pulse dosing required for treatment of a concurrent medical condition is allowed, provided treatment duration is no greater than 2 weeks
* No concurrent corticosteroids (e.g., dexamethasone)
Radiotherapy
* More than 14 days since prior radiotherapy
* No prior radiotherapy to more than 25% of bone marrow
* No plans for radiotherapy within the next 6 months
* Concurrent palliative radiotherapy for skeletal pain allowed
Surgery
* More than 14 days since prior surgery
* No plans for surgery within the next 6 months
Other
* Acute toxic effects of prior therapy (except for alopecia and neurotoxicity) must have resolved to grade 0, 1, or the patient's baseline
* Treatment-related neurotoxicity must have resolved to the patient's baseline, not to exceed grade 2
* Chronic bisphosphonates for bone pain allowed only for maintenance doses
* More than 2 weeks since prior nonmyelosuppressive antimyeloma therapy
* More than 2 weeks since prior macrolide antibiotics
* No other concurrent investigational agents
* No concurrent macrolide antibiotics
* No concurrent participation in another treatment clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00060203
Study Brief:
Protocol Section:
NCT00060203