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Completed

NCT Number: NCT01186224

Plerixafor Harvesting And No Chemotherapy for Transplantation of Autologous STem Cells In Cancer (PHANTASTIC)

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Plasma Cell Dyscrasia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Haematology, University of Liverpool

Liverpool, Merseyside, L7 8XP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plerixafor and G-CSF

Drug

G-CSF will be given daily from day 1, which will usually be timed to fall toward the end of the working week. Plerixafor will commence on day 4 at as near to 10 PM as practicable, and also on day 5 and subsequent days (maximum of 4 total days) at a similar time of day if insufficient CD34+ cells have been collected. Stem cell harvesting will be carried out on day 5 and if necessary on days 6, 7 and 8, until the target yield of 4 x 106 CD34+ cells /kg recipient weight have been achieved.

The daily dose of G-CSF is 300 ug for patients up to and including 60kg in weight; 480 ug for patients over 60 kg but under 96 kg, and 600 ug for patients weighing 96 kg or more. This equates to a dose of at least 5 ug/kg (maximum 8 mg/kg) for all patients up to 120 kg. The daily dose of plerixafor is 240 ug/kg if the creatinine clearance is equal to or greater than 50mls/minute; if less than this then the dose is 160 ug/kg daily.

Primary outcomes

  1. 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.

    Time frame: 3 weeks following initiation of mobilisation

Secondary outcomes

  1. Serial neutrophil and platelet counts during mobilisation

    Time frame: 1 Day

  2. Total stem cell yield in 1-2 aphereses

    Time frame: 1 day

  3. The usage of plerixafor and the number and timing of apheresis collections

    Time frame: 1 day

  4. The time to neutrophil engraftment after subsequent transplantation

    Time frame: First of 2 consecutive days on which the neutrophil count equals or exceeds 0.5 x 109/litre

  5. The time to platelet engraftment after subsequent transplantation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Liverpool

Other

Collaborators

  • Genzyme, a Sanofi Company

Registry information

Official study title

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

Acronym: PHANTASTIC

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 23, 2010
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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