Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

Sponsor

University of Florida (Other)

Overall Status

Completed

CT.gov ID

NCT01339572

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma Multiple Myeloma	Drug: Plerixafor Drug: Filgrastim	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Plerixafor 240 mcg/kg/day based on ideal body weight will be given for the following conditions: Pre-apheresis peripheral blood CD34+ count <20 cells/μL on day 5. Estimated CD34+ cell collection is < 25% of target cell dose after 1 day of apheresis. Estimated CD34+ cell collection is < 50% of target cell dose after 2 days of apheresis. Other Names: AMD3100 Drug: Filgrastim All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient: Standard risk: 5 μg/kg SQ BID. High risk: 10 μg/kg SQ BID. Other Names: G-CSF
Active Comparator: Observation 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.	Drug: Filgrastim All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient: Standard risk: 5 μg/kg SQ BID. High risk: 10 μg/kg SQ BID. Other Names: G-CSF

Arm

Intervention/Treatment

Experimental: 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.

Drug: Plerixafor

240 mcg/kg/day based on ideal body weight will be given for the following conditions: Pre-apheresis peripheral blood CD34+ count <20 cells/μL on day 5. Estimated CD34+ cell collection is < 25% of target cell dose after 1 day of apheresis. Estimated CD34+ cell collection is < 50% of target cell dose after 2 days of apheresis.

Other Names:

AMD3100

Drug: Filgrastim

All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient: Standard risk: 5 μg/kg SQ BID. High risk: 10 μg/kg SQ BID.

Other Names:

G-CSF

Active Comparator: Observation

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.

Drug: Filgrastim

Other Names:

G-CSF

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shands Cancer Hospital at the University of Florida	Gainesville	Florida	United States	32608

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Jack W Hsu, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT01339572

Other Study ID Numbers:

Plerixafor-UF01

First Posted:

Apr 20, 2011

Last Update Posted:

Aug 1, 2017

Last Verified:

Jul 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Florida

autologous transplantation

peripheral stem cell mobilization

Additional relevant MeSH terms:

Multiple Myeloma

Plerixafor

Study Results

No Results Posted as of Aug 1, 2017