Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

University of Florida

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma; Non-Hodgkin's Lymphoma

Treatments: Drug: Plerixafor; Drug: Filgrastim

Study type: Interventional

Funder types: Other

Identifiers

NCT01339572

Plerixafor-UF01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Plerixafor

Experimental group

Description:

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.

Treatment:

Drug: Plerixafor

Drug: Filgrastim

Observation

Active Comparator group

Description:

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.

Treatment:

Drug: Filgrastim