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Plerixafor and G−CSF for the Mobilisation of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients With Non−Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) − Safety Study in a General Autologous Transplant Population

Phase 3
18 Years
Not Enrolling
Lymphoma (Non-Hodgkin's Lymphoma), Hodgkin's Disease or Multiple Myeloma, Front Line Mobilization, Transplantation

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Trial Information

Plerixafor and G−CSF for the Mobilisation of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients With Non−Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) − Safety Study in a General Autologous Transplant Population

Patients with advanced or treatment-refractory Multiple Myeloma (MM), Hodgkin's Disease (HD)
and Non-Hodgkin's Lymphoma (NHL) may be successfully treated with high dose chemotherapy
followed by autologous transplantation of peripheral blood stem cells (PBSCs). Successful
engraftment of peripheral blood stem cells (PBSCs) is well correlated with the number of
CD34+ cells infused.

Stem cell collection with plerixafor could have a major benefit by increasing the
circulating number of PBSCs and decreasing the number of apheresis sessions required to
collect a sufficient number of PBSCs for transplant.

This is a multi-centre, open label, single-arm study intended to further investigate the
safety and efficacy of plerixafor in patients with NHL, HD, or MM. Patients who have
previously failed stem cell mobilisation attempts or who have previously received more than
one autologous or any allogeneic stem cell transplant are not eligible.

Screening for eligibility will take place up to 30 days before the first dose of G-CSF.
Patients will receive a stem cell mobilisation regimen consisting of plerixafor and G-CSF.
Patients will be given G-CSF for 4 consecutive days in the morning. Starting on the evening
of Day 4, plerixafor will be administered subcutaneously (SC). The plerixafor dose will be
timed to allow for a 10- to 11-hour interval between the plerixafor dosing and the
initiation of apheresis. Patients may continue to receive the evening dose of plerixafor
then G-CSF the next morning followed by apheresis for up to a total of 5 apheresis
procedures until a minimum of at least 5 x 106 CD34+ cells/kg for NHL/HD or 6 x 106 CD34+
cells/kg for MM are collected. More cells may be collected if done within the 5 apheresis
procedures. Stem cell collection will take place using standard procedures.

Following the last apheresis, patients will undergo pre-transplant myeloablative
chemotherapy followed by transplantation of the collected autologous stem cells, using the
established protocols and procedures at each site.

Peripheral blood samples will be collected for determining the number of CD34+ cells in the
peripheral blood. In addition, a sample will be obtained from each apheresis product to
determine the quantity of CD34+ cells collected after each procedure.

Safety data will be reported according to guidelines provided in the protocol. Adverse
event (AE) guidance is summarised in the protocol. Investigators will grade AEs using the
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE),
version 3.0.

Efficacy will be based on the quantity of CD34+ cells harvested and the subsequent
engraftment and graft status. Patients who undergo haematopoietic stem cell transplantation
will be monitored for graft status at 100 days, 6 months, and 12 months.

Inclusion Criteria:

- Diagnosis of MM, NHL, or HD in partial response (PR) or complete response (CR)

- Eligible and planned for an autologous haematopoietic stem cell transplantation

- Written informed consent

- At least 18 years of age (inclusive)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- White blood cell (WBC) count ≥2.5 x 10^9/L

- Absolute neutrophil count (ANC) ≥1.5 x 10^9 /L

- Platelet count ≥100 x 10^9/L

- Serum creatinine ≤2.2 mg/dL

- Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT),
alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), and total
bilirubin <2.5 x upper limit of normal (ULN)

- Adequate cardiac, renal, and pulmonary function sufficient to undergo apheresis and
transplantation, i.e., eligible by institutional standards for autologous stem cell

- All patients must agree to use a highly effective method of contraception whilst on
study treatment and for at least 3 months following plerixafor treatment (including
both female patients of child-bearing potential and male patients with partners of
child-bearing potential). Effective birth control includes: a) birth control pills,
depot progesterone, or an intrauterine device plus one barrier method, or b) two
barrier methods. Effective barrier methods are: male and female condoms, diaphragms,
and spermicides (creams or gels that contain a chemical to kill sperm). For patients
using a hormonal contraceptive method, information about any interaction of
plerixafor with hormonal contraceptives is not known.

Exclusion Criteria:

- History of any acute or chronic leukaemia (including myelodysplastic syndrome)

- Prior allogeneic transplantation or more than one prior autologous transplantation

- Failed previous CD34+ cell collection attempts (either due to insufficient yield in
apheresis product, or ineligible for apheresis because of inadequate mobilisation of
CD34+ cells into peripheral blood)

- Less than 4 weeks since last anti-cancer therapy (including chemotherapy,
biologic/immunologic, radiation) or less than 6 weeks if prior therapy with
nitrosourea or mitomycin (for therapies with long-acting agents, a treatment-free
interval of at least 2 half-lives should be considered) with the exception of ;
Treatment with thalidomide, dexamethasone, lenalidomide (Revlimid®), and/or
bortezomib (Velcade®) which is allowed up to 7 days prior to the first dose of G-CSF.

- Bone marrow involvement >20% assessed based on the most recent bone marrow aspirate
or biopsy

- Treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF
for mobilisation

- Known to be human immunodeficiency virus (HIV) positive

- Active hepatitis B or hepatitis C

- Acute infection (febrile, i.e., temperature >38°C) within 24 hours prior to dosing or
antibiotic therapy within 7 days prior to the first dose of G-CSF

- Hypercalcaemia as evidenced by >1 mg/dL above ULN

- Previously received investigational therapy within 4 weeks of enrolling in this
protocol or currently enrolled in another investigational protocol during the
mobilisation phase

- Central nervous system involvement including brain metastases or leptomeningeal

- Pregnant or nursing women

- Electrocardiogram (ECG) or study result (exercise study, scan) indicative of cardiac
ischaemia or a history of clinically significant rhythm disturbance (arrhythmias), or
other conduction abnormality in the last year that in the opinion of the Investigator
warrants exclusion of the subject from the trial.

- Co-morbid condition(s), which in the opinion of the Investigator, renders the patient
at high risk from treatment complications or impairs their ability to comply with the
study treatment and protocol

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To confirm the safety profile of plerixafor to mobilise stem cells when used in patients with lymphoma or MM who are eligible to undergo treatment with an autologous haematopoietic stem cell transplant

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme Europe, B.V.


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

September 2008

Completion Date:

November 2010

Related Keywords:

  • Lymphoma (Non-Hodgkin's Lymphoma)
  • Hodgkin's Disease or Multiple Myeloma
  • Front Line Mobilization
  • Transplantation
  • Mobilisation stem cells
  • G-CSF Mobilisation Regimen
  • Lymphoma
  • Multiple Myeloma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell