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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT00378105
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with multiple myeloma based on standard diagnostic criteria or by the new International Myeloma Foundation 2003 Diagnostic Criteria
* Must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma
* Negative serum or urine pregnancy test
* Age 18 years or older
* Karnofsky performance status of greater or equal to 60
Exclusion Criteria:
* Greater or equal to Grade 2 peripheral neuropathy on clinical examination within 14 days before enrollment
* Renal insufficiency (serum creatinine \>2.5 mg/dL)
* Evidence of mucosal or internal bleeding and/or platelet refractory
* ANC (absolute neutrophil count)\< 1000 cells/mm3
* Hemoglobin \< 8.0 g/dL
* AST (aspartate aminotransferase) or ALT (alanine aminotransferase) greater than or equal to 2 x ULN (upper limit of normal)
* Concomitant therapy medications that include corticosteroids
* Myocardial infarction within 6 months prior to enrollment according to NYHA (New York Heart Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* Clinically relevant active infection or serious co-morbid medical conditions
* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer
* Pregnant or breast-feeding
* Serious medical or psychiatric illness likely to interfere with participation in study
* Uncontrolled diabetes mellitus
* Hypersensitivity to acyclovir or similar anti-viral drug
* POEMS syndrome
* Known HIV infection
* Known active hepatitis B or C viral infection
* Known intolerance to steroid therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00378105
Study Brief:
Protocol Section:
NCT00378105