Economic Evaluation of the Use of Plerixafor for Autologous HSC Transplantation for Multiple Myeloma (PLERIXAFOR)

Institut Paoli-Calmettes

Status: Completed

Conditions: Multiple Myeloma

Treatments: Other: Economic evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT02861287

PLERIXAFOR-IPC 2013-002

Details and patient eligibility

About

This study aims to realize an economic evaluation of the introduction of Plerixafor in addition to G-CSF and alternative options, in patients with multiple myeloma (MM) who failed or insufficiently mobilize peripheral blood stem and progenitor cells in response to G-CSF alone.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients diagnosed with Multiple Myeloma who were eligible for high-dose melphalan supported with autologous hematopoietic stem cell transplantation (HSCT) as part of their treatment plan
• First mobilization attempt
• "rhG-CSF alone" mobilization regimen
• Failed mobilization as documented by an increase in CD34+ cell mobilization deemed insufficient to initiate apheresis (below 15/µL), after the 4 first injections of rhG-CSF that are administered in the evening

Exclusion criteria

• Age < 18 years;
• Primary diagnosis other than MM
• 2nd or subsequent mobilization attempt
• Patients who previously received HDCT + autologous HSCT
• Chemotherapy-based mobilization regimen
• Efficient mobilization, allowing for apheresis and collection of the target cell number (5x106 CD34+ cells/kg for every planned autologous transplantation as per institutional SOPs).

Trial design

60 participants in 2 patient groups

Study cohort

Description:

patients with Multiple Myeloma who underwent PBSC mobilization since December 2009 and who received plerixafor in line with inclusion criteria

Treatment:

Other: Economic evaluation

Historical cohort

Description:

patients with Multiple Myeloma who underwent PBSC mobilization immediately prior to marketing authorization and clinical utilization of Plerixafor which is before December 2009 (over the 2007-2009 period)

Treatment:

Other: Economic evaluation