Plerixafor Harvesting And No Chemotherapy for Transplantation of Autologous STem Cells In Cancer (PHANTASTIC)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- Serial neutrophil and platelet counts during mobilisation [1 Day]
- 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]
- 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]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dept of Haematology, University of Liverpool | Liverpool | Merseyside | United Kingdom | L7 8XP |
Sponsors and Collaborators
- University of Liverpool
- Genzyme, a Sanofi Company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PHANTASTIC
- 2009-013798-16