Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

Multiple Myeloma Clinical Trial

Official title:

Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339572
• Other study ID #: Plerixafor-UF01
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2011
• Last updated: July 27, 2017
• Start date: April 2011
• Est. completion date: November 2015

Study information

• Verified date: July 2017
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Non-Hodgkin's Lymphoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Shands Cancer Hospital at the University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers	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.	Day 2 of apheresis
Secondary	Economic impact	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.	Day 2 of mobilization and Day +100 after transplantation
Secondary	Kinetics of CD34+ mobilization with early introduction of plerixafor	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.	On Day 1 and Day 2 of apheresis
Secondary	Graft composition	Graft composition will be analyzed on each day of successful apheresis. Cell populations to be quantitated include total CD3+ lymphocytes, CD4+ lymphocytes, CD8+ lymphocytes.	On Day 1 and Day 2 of apheresis