Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

Phase 2

Completed

• Conditions: Non-Hodgkin's Lymphoma; Multiple Myeloma
• Interventions: Drug: Plerixafor; Drug: Filgrastim

• Registration Number: NCT01339572
• Lead Sponsor: University of Florida

Brief Summary

This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.

Detailed Description

Peripheral blood stem cells are now considered the standard source of stem cells for autologous stem cell transplants. Unfortunately, there is still a 20-30% chance that inadequate numbers of stem cells will be collected, resulting in prolonged recovery of cell counts after transplantation and increased transfusion dependence. There is also a significant economic burden associated with remobilization and a risk that delays in collecting sufficient numbers of stem cells can result in an increased chance of disease recurrence prior to transplantation.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Patients with multiple myeloma or non-Hodgkin's lymphoma with a planned autologous transplant and who are eligible for peripheral stem cell mobilization.
• Karnofsky Performance Status ≥ 70.
• Age ≥ 18
• Less than 30% involvement of marrow with disease.

Exclusion Criteria

• > 30% marrow involvement with disease
• Age < 18.
• Pregnant women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plerixafor	Filgrastim	All subjects will receive filgrastim as part of their primary mobilization regimen. If a subject does not meet minimum peripheral blood CD34+ cell count levels or fails to adequately collect a threshold number of CD34+ cells, plerixafor will be added to the mobilization regimen.
Observation	Filgrastim	All subjects will receive filgrastim as part of their primary mobilization regimen. If the subject meets minimum peripheral blood CD34+ cell count levels or adequately collects a threshold number of CD34+ cells, plerixafor will not be added to the mobilization regimen.
Plerixafor	Plerixafor	All subjects will receive filgrastim as part of their primary mobilization regimen. If a subject does not meet minimum peripheral blood CD34+ cell count levels or fails to adequately collect a threshold number of CD34+ cells, plerixafor will be added to the mobilization regimen.

Primary Outcome Measures

Name	Time	Method
Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers	Day 2 of apheresis	The primary endpoint of the study will be the rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers based on peripheral blood CD34+ cell counts or CD34+ cell collection efficiency after 2 consecutive days of apheresis. Success will be defined as the ability to avoid a second mobilization attempt. Results will be compared to matched historical controls.

Secondary Outcome Measures

Name	Time	Method
Economic impact	Day 2 of mobilization and Day +100 after transplantation	The economic impact of plerixafor use will be divided into two phases, mobilization and transplantation. The comparator arm for the mobilization phase would be matched historical controls. The comparator arm for the transplant phase will be patients who did not require plerixafor for mobilization during the study period.
Kinetics of CD34+ mobilization with early introduction of plerixafor	On Day 1 and Day 2 of apheresis	The kinetics of CD34+ cell counts during mobilization in this setting is unknown. We will attempt to determine mobilization kinetics by following peripheral blood CD34+ counts daily starting from first day of plerixafor administration until completion of apheresis. Kinetics will be analyzed according to the following parameters: * Peripheral CD34 cell counts on each day of apheresis.; * Total CD34 cells collected on each day of apheresis; * Multiple myeloma vs. NHL.
Graft composition	On Day 1 and Day 2 of apheresis	Graft composition will be analyzed on each day of successful apheresis. Cell populations to be quantitated include total CD3+ lymphocytes, CD4+ lymphocytes, CD8+ lymphocytes.

Trial Locations

Locations (1)

Shands Cancer Hospital at the University of Florida; 🇺🇸 Gainesville, Florida, United States