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Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma, Multiple Myeloma

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Trial Information

Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers

Outcome Description:

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.

Outcome Time Frame:

Day 2 of apheresis

Safety Issue:

No

Principal Investigator

Jack W Hsu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida

Authority:

United States: Institutional Review Board

Study ID:

Plerixafor-UF01

NCT ID:

NCT01339572

Start Date:

April 2011

Completion Date:

April 2015

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Multiple Myeloma
  • autologous transplantation
  • peripheral stem cell mobilization
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Shands Cancer Hospital at the University of Florida Gainesville, Florida  32608