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

Not Applicable

Completed

• Conditions: Multiple Myeloma; Plasma Cell Dyscrasia; Lymphoma; Lymphoproliferative Disorders
• Interventions: Drug: Plerixafor and G-CSF

• Registration Number: NCT01186224
• Lead Sponsor: University of Liverpool

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-02
• Study Start: 2010-05
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Plerixafor plus G-CSF for patients undergoing stem cell harvesting	Plerixafor and G-CSF	Single arm comparison of plerixafor plus G-CSF for patients undergoing stem cell harvesting

Primary Outcome Measures

Name	Time	Method
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.	3 weeks following initiation of mobilisation

Secondary Outcome Measures

Name	Time	Method
Serial neutrophil and platelet counts during mobilisation	1 Day
The time to platelet engraftment after subsequent transplantation	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
Total stem cell yield in 1-2 aphereses	1 day
The usage of plerixafor and the number and timing of apheresis collections	1 day
The time to neutrophil engraftment after subsequent transplantation	First of 2 consecutive days on which the neutrophil count equals or exceeds 0.5 x 109/litre

Trial Locations

Locations (1)

Dept of Haematology, University of Liverpool; 🇬🇧 Liverpool, Merseyside, United Kingdom