Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

NCT ID: NCT01339572

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2015-11-30

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.

Conditions

Non-Hodgkin's Lymphoma; Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Plerixafor

Intervention Type: DRUG

240 mcg/kg/day based on ideal body weight will be given for the following conditions:

1. Pre-apheresis peripheral blood CD34+ count <20 cells/μL on day 5.

2. Estimated CD34+ cell collection is < 25% of target cell dose after 1 day of apheresis.

3. Estimated CD34+ cell collection is < 50% of target cell dose after 2 days of apheresis.

Filgrastim

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Filgrastim

Intervention Type: DRUG

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.

Interventions

Plerixafor

240 mcg/kg/day based on ideal body weight will be given for the following conditions:

1. Pre-apheresis peripheral blood CD34+ count <20 cells/μL on day 5.

2. Estimated CD34+ cell collection is < 25% of target cell dose after 1 day of apheresis.

3. Estimated CD34+ cell collection is < 50% of target cell dose after 2 days of apheresis.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

AMD3100; G-CSF

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jack W Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Shands Cancer Hospital at the University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

Plerixafor-UF01

Identifier Type: -

Identifier Source: org_study_id