Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide and Planning to Undergo Autologous Stem Cell Transplant

Phase 2

Completed

• Conditions: Stage II Multiple Myeloma; Stage III Multiple Myeloma; Multiple Myeloma; Stage I Multiple Myeloma; Refractory Multiple Myeloma
• Interventions: Drug: plerixafor; Drug: filgrastim

• Registration Number: NCT00998049
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study First Submitted: 2009-10-19
• Study First Submitted QC: 2009-10-19
• Study First Posted: 2009-10-20
• Study Start: 2009-12
• Primary Completion: 2011-11
• Results First Submitted: 2012-06-26
• Results First Submitted QC: 2012-06-26
• Results First Posted: 2012-07-30
• Status Verified: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-24
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Plerixafor	plerixafor	Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Plerixafor	filgrastim	Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.

Primary Outcome Measures

Name	Time	Method
Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis	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 Outcome Measures

Name	Time	Method
CD34 Yield on Day 1	Day 1	Number of CD34 cells/kg collected on day 1.
CD34 Yield Day 2	Day 2	Number of CD34 cells/kg collected on 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)	Number (median and 95% confidence interval) of days to reach 6 million CD34 cells/kg was estimated using the Kaplan Meier method. Participants were lower than 6 million CD34 cells/kg at time of last follow-up will be censored at that date.
Rate of Failure to Mobilize	Duration of apheresis (up to 7 days)	The rate of failure to mobilize will be estimated by dividing the number of patients that fail to mobilize by the total number of evaluable patients. A patient is considered a failure if they never achieve 2.5 million CD34 cells/kg.

Trial Locations

Locations (2)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States