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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT01095757
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-70 years
2. Multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) patients in first or second complete or partial remission
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Up to 3 prior treatment regimens
5. Meet all eligibility requirements for autologous transplant
6. Adequate marrow function defined as white blood cells (WBC) \>3,000; ANC \>1,500/mm3; platelets \>75,000/mm3
7. Adequate renal function defined as creatinine clearance \> 30 mL/min by Cockcroft-Gault
8. Adequate liver function defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin \< 2 times upper limit of normal
9. Able to provide informed consent
10. Women not pregnant and agree to use contraception
Exclusion Criteria:
1. High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
2. Brain metastases or carcinomatous meningitis
3. Previous treatment with high dose chemotherapy and autologous transplant
4. Previous attempt to collect B-hematopoietic progenitor cells (HPCs) following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors
5. Acute infection or unexplained fever \>38°C
6. Weight \> 175% of ideal body weight as defined by the Devine equation
7. Experimental therapy within 4 weeks
8. Cytokine administration in the previous 14 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01095757
Study Brief:
Protocol Section:
NCT01095757