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A Comparison of Plerixafor/G-CSF With Chemotherapy/G-CSF for Stem Cell Mobilisation

18 Years
Open (Enrolling)
Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoma, Lymphoproliferative Disorders

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Trial Information

A Comparison of Plerixafor/G-CSF With Chemotherapy/G-CSF for Stem Cell Mobilisation

Inclusion Criteria:

- All of the following must be satisfied:

Aged 18 or over

Able to give informed written consent.

Diagnosis of EITHER multiple myeloma or related plasma cell dyscrasia, OR any form of
lymphoma or associated lymphoproliferative disease Autologous stem cell transplantation is
planned as the next course of treatment.

The patient has not previously undergone a mobilisation attempt for the current
transplant. Patients who have received previous autologous transplants at least 2 years
previously are eligible, as long as stem cell mobilisation has not been attempted for the
current transplant.

No serious concomitant illness (e.g. heart disease) that might preclude completion of the

Creatinine clearance of at least 30 mls/min. Note that a dose reduction of plerixafor is
required where the creatinine clearance is between 30-50 mls/min; see section 3.3/5.1/5.3.

Negative pregnancy test in women of childbearing age.

Exclusion Criteria:

- Unable to give informed written consent

Pregnancy or lactating

Creatinine clearance of less than 30 mls/min. Patients with clearances lower than this may
still be able to receive plerixafor at reduced dosage following discussion with the trial
co-ordinators, but are not eligible for entry into this trial.

Any previous attempt at mobilisation for the current transplant. Patients with any form of
leukaemia, INCLUDING PLASMA CELL LEUKAEMIA, are not eligible.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

A composite primary endpoint of BOTH an adequate stem cell harvest (≥4 x 106 CD34+/kg in no more than 2 aphereses); AND a neutrophil count that never falls below 1.0 x 109 / Litre in the 3 weeks following initiation of mobilisation.

Outcome Time Frame:

3 weeks following initiation of mobilisation

Safety Issue:



United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

May 2010

Completion Date:

May 2012

Related Keywords:

  • Multiple Myeloma
  • Plasma Cell Dyscrasia
  • Lymphoma
  • Lymphoproliferative Disorders
  • Lymphoma
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Paraproteinemias