Clinical trial NCT01186224: Plerixafor Harvesting And No Chemotherapy for Transplantation of Autologous STem Cells In Cancer (PHANTASTIC)
Official title: A Comparison of Plerixafor/G-CSF With Chemotherapy/G-CSF for Stem Cell Mobilisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Plasma Cell Dyscrasia
Lymphoma
Lymphoproliferative Disorders
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2010-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 3 weeks following initiation of mobilisation
Secondary outcomes:
measure: Serial neutrophil and platelet counts during mobilisation
timeFrame: 1 Day
measure: Total stem cell yield in 1-2 aphereses
timeFrame: 1 day
measure: The usage of plerixafor and the number and timing of apheresis collections
timeFrame: 1 day
measure: The time to neutrophil engraftment after subsequent transplantation
timeFrame: First of 2 consecutive days on which the neutrophil count equals or exceeds 0.5 x 109/litre
measure: The time to platelet engraftment after subsequent transplantation
timeFrame: First of two consecutive days on which the platelet count equals or exceeds 50 x 109/litre, having been free of platelet transfusion for at least 48 hours
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Dept of Haematology, University of Liverpool
state: Merseyside
Study officials:
References: