Phase II Trial of Intravenously Administered AMD3100 (Plerixafor) for Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation Following a Lenalidomide Based Initial Therapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis
Study Overview
Brief Summary
Rationale: Giving colony-stimulating factors, such as G-CSF and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Purpose: This phase II trial is studying how well plerixafor works in patients with multiple myeloma previously treated with lenalidomide and planning to undergo autologous stem cell transplant.
Detailed Description
Primary Objective: I. To determine the proportion of patients reaching a stem cell yield of 3 million CD34 cells/kg by second day of apheresis with intravenously administered AMD3100 among patients receiving primary therapy for myeloma with lenalidomide. Secondary Objectives: I. Safety and tolerability of intravenously administered AMD3100. II. Rate of failure to mobilize. Outline: Patients receive plerixafor IV on days 5-8 and filgrastim subcutaneously on days 1-8 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Plerixafor
Plerixafor 160mg/kg/dose by IV on days 5-8
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Intervention: plerixafor (Drug)
Plerixafor
Plerixafor 160mg/kg/dose by IV on days 5-8
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Intervention: filgrastim (Drug)
Outcomes
Primary Outcomes
Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis
Time Frame: After 2 days of apheresis
Number of CD34 cells/kg collected on days 1-2. Apheresis is the process when blood is taken out through a catheter in a vein in one arm, blood is sent through a machine that takes out the stem cells and the rest of the blood is then returned through a vein in your other arm.
Secondary Outcomes
- CD34 Yield on Day 1(Day 1)
- CD34 Yield Day 2(Day 2)
- Median Number of Days of Apheresis(Duration of apheresis (up to 7 days))
- Time to Reach 6 Million CD34 Cells(Duration of apheresis (up to 7 days))
- Rate of Failure to Mobilize(Duration of apheresis (up to 7 days))