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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT00526734
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of symptomatic stage I or stage II-III multiple myeloma
* Newly diagnosed disease
* No amyloidosis
PATIENT CHARACTERISTICS:
Inclusion criteria:
* ECOG performance status 0-2
* ANC ≥ 1.0 x 10\^9/L (without colony-stimulating factors)
* Platelet count ≥ 50 x 10\^9/L (without transfusion support within the past 7 days)
* Serum calcium \< 14 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times ULN
* Creatinine clearance ≥ 50 mL/min
* Fertile patients must use effective contraception
* Negative pregnancy test
* Willing and able to comply with protocol requirements
Exclusion criteria:
* Myocardial infarction within the past 6 months
* New York Heart Association class III or IV heart failure
* Uncontrolled angina
* Severe uncontrolled ventricular arrhythmia
* Acute ischemia or active conduction system abnormalities as evidenced by ECG
* Serious medical condition that could prolong hematological recovery or preclude completion of or tolerance to protocol therapy
* Seropositive for HIV antibody
* Known hepatitis B surface antigen positivity OR active hepatitis C infection
* Active systemic infection requiring treatment
* Pregnant or nursing
* Poor psychiatric condition
PRIOR CONCURRENT THERAPY:
* No plasmapheresis within the past 4 weeks
* No major surgery within the past 4 weeks
* No anticancer therapy within the past 5 years, except treatment for basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
* No other concurrent G-CSF growth factors
* No concurrent enrollment in another investigational clinical trial
* No concurrent investigational agent that would contraindicate the use of pegfilgrastim as either a mobilization agent or a hematological recovery agent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00526734
Study Brief:
Protocol Section:
NCT00526734