NCT00998049

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma
• Refractory Multiple Myeloma
• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma

Interventions

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

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-11-01
• Completion: 2015-04-01
• First posted: 2009-10-20
• Last updated: 2015-05-14
• Results posted: 2012-07-30

Locations

2 sites across 1 country: United States