Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg
Study Overview
Brief Summary
The purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor.
The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-70 years
- •Multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) patients in first or second complete or partial remission
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Up to 3 prior treatment regimens
- •Meet all eligibility requirements for autologous transplant
- •Adequate marrow function defined as white blood cells (WBC) >3,000; ANC >1,500/mm3; platelets >75,000/mm3
- •Adequate renal function defined as creatinine clearance > 30 mL/min by Cockcroft-Gault
- •Adequate liver function defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin < 2 times upper limit of normal
- •Able to provide informed consent
- •Women not pregnant and agree to use contraception
Exclusion Criteria
- •High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
- •Brain metastases or carcinomatous meningitis
- •Previous treatment with high dose chemotherapy and autologous transplant
- •Previous attempt to collect B-hematopoietic progenitor cells (HPCs) following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors
- •Acute infection or unexplained fever >38°C
- •Weight > 175% of ideal body weight as defined by the Devine equation
- •Experimental therapy within 4 weeks
- •Cytokine administration in the previous 14 days
Arms & Interventions
Plerixafor + Chemo and G-CSF
Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
Intervention: Plerixafor (Drug)
Outcomes
Primary Outcomes
Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg
Time Frame: Within the first 4 days following the first dose of Plerixafor
Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis
Time Frame: Within the first 4 days following the first dose of Plerixafor
Secondary Outcomes
- Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500)(Within the first 4 days following the first dose of Plerixafor)
Investigators
Edmund Waller
MD
Emory University