Plerixafor Harvesting and No Chemotherapy for Transplantation of Autologous STem Cells in Cancer (PHANTASTIC)

University of Liverpool

Status: Completed

Conditions: Plasma Cell Dyscrasia; Multiple Myeloma; Lymphoma; Lymphoproliferative Disorders

Treatments: Drug: Plerixafor and G-CSF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01186224

PHANTASTIC

2009-013798-16 (EudraCT Number)

Details and patient eligibility

About

To assess the efficacy and toxicity of plerixafor (AMD 3100) together with granulocyte-colony stimulating factor (G-CSF) for stem cell mobilisation, in patients with myeloma or lymphoma requiring high dose chemotherapy with stem cell rescue.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 study.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Plerixafor plus G-CSF for patients undergoing stem cell harvesting

Experimental group

Description:

Single arm comparison of plerixafor plus G-CSF for patients undergoing stem cell harvesting

Treatment:

Drug: Plerixafor and G-CSF