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 @ 12:29 AM
Ignite Modification Date:
2025-12-25 @ 12:29 AM
NCT ID:
NCT00395967
Eligibility Criteria:
Inclusion Criteria (Abbreviated List):
* Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM)
* Eligible for autologous transplantation
* \<=3 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
* \>4 weeks since last cycle of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
* Total dose of melphalan ≦200 mg
* Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
* White blood cell (WBC) count \>3.0\*10\^9/L prior to first dose of G-CSF
* Absolute polymorphonuclear leukocyte (PMN) count \>1.5\*10\^9/L prior to first dose of G-CSF
* Platelet (PLT) count \>100\*10\^9/L prior to first dose of granulocyte colony-stimulating factor (G-CSF)
* Serum creatinine ≥2.2 mg/dL
* SGOT, SGPT and total bilirubin \<2 times upper limit of normal (ULN)
* Negative for HIV
* CD34+ cell count between 5 and 19 CD34+ cells/ml after 5 days of mobilization with G-CSF alone
Exclusion Criteria (Abbreviated List):
* A co-morbid condition which, in the view of the investigator, renders the patient at high risk from treatment complications
* Failed previous stem cell collection or collection attempts
* A residual acute medical condition resulting from prior chemotherapy
* Active brain metastases or carcinomatous meningitis
* Active infection requiring antibiotic treatment
* Received prior radio-immunotherapy with Zevalin or Bexxar
* Received bone-seeking radionuclides (e.g., holmium)
* Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first dose of G-CSF
* History of ventricular arrhythmias, including electrocardiogram (ECG)-documented premature ventricular contractions (PVCs), during the last 3 years
* Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase
* Had an apheresis yield \>1.3\*10\^6 CD34+ cells/kg on Day 5 (Applicable only to patients who, after 5 days of G-CSF mobilization, have peripheral blood (PB) CD34+ count of 8-19 cells/µl inclusive).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00395967
Study Brief:
Protocol Section:
NCT00395967