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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT01279694
Eligibility Criteria:
Inclusion Criteria:
* Karnofsky performance status (KPS) of at least 60%
* Life expectancy of more than 3 months.
* Must understand and voluntarily sign an informed consent form
* Age \>65 years at the time of signing consent
* Previously untreated, symptomatic multiple myeloma as defined by the 2 criteria below:○ MM diagnostic criteria (all 3 required):· Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma· Monoclonal protein present in the serum and/or urine· Myeloma-related organ dysfunction (at least 1 of the following) \[C\] Calcium elevation in the blood (serum calcium \>10.5 mg/L or upper limit of normal)\[R\] Renal insufficiency (serum creatinine \> 2 mg/dL)\[A\] Anemia (hemoglobin \<10 g/dL or 2 g \< normal)\[B\] Lytic bone lesions or osteoporosisAND have measurable disease by protein electrophoresis analyses as defined by one or more of the following:· IgG multiple myeloma: Serum monoclonal paraprotein (M protein) level by SPEP ³ 0.5 g/dL or urine M-protein level ³ 200 mg/24 hours· IgA multiple myeloma: Serum M-protein level ³ 0.5 mg/dL or urine M-protein level ³ 200 mg/24 hours· IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dL or urine M-protein level ≥ 200 mg/24 hours· IgD multiple myeloma: Serum M-protein level ³ 0.05 g/dL or urine M-protein level ³ 200 mg/24 hours Light chain multiple myeloma: Patients with serum free light chain disease in whom the involved light chain measures ≥ 10 mg/dL
* ECOG performance status of 0, 1, or 2
* Able to adhere to the study visit schedule and other protocol requirements
* Affiliation number to National Health Care System
Exclusion Criteria:
* Patients are ineligible if they meet any of the following criteria: 1 Previous treatment with antimyeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid \[i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 28 days (4 weeks) of consent\]).
* Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study.
* Female of childbearing potential
* Any of the following laboratory abnormalities:· Absolute neutrophil count (ANC) \< 1,000 cells/mL (1.0 × 109/L) · Platelet count \< 50,000 cells/mL (50 × 109/L) for patients in whom \< 50% of bone marrow nucleated cells are plasma cells; but platelet count \<30,000 cells/mL for patients in whom ³ 50% of bone marrow nucleated cells are plasma cells · Serum SGPT/ALT \> 3.0 × upper limit of normal (ULN); Bilirubin \>2 × ULN \[ALT more specific to liver\]· Creatinine clearance ≤ 30 mL/min (Cockcroft-Gault calculation)5 Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ³ 3 years. Exceptions include the following:o Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Carcinoma in situ of the cervix Carcinoma in situ of the breast6 Incidental histological finding of prostate cancer (TNM stage of T1a or T1b) Peripheral neuropathy of \> grade 2 severity.
* Known HIV positivity or active infectious hepatitis, type A, B, or C.
* Myocardial infarction within 3 months of enrollment, unstable angina within 2 months or New York Heart Association class III or IV heart failure.
* Oral or IV fluid hydration contraindicated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01279694
Study Brief:
Protocol Section:
NCT01279694