Patients with lymphoma or myeloma, who require high dose chemotherapy with autologous stem cell rescue (known colloquially as an autograft). Plerixafor is used to mobilise the autologous stem cells for routine harvesting, a few weeks before the transplant. MedDRA version: 14.0 Level: LLT Classification code 10053946 Term: Stem cell mobilization System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Plerixafor
Pharmaceutical Form: Solution for injection
Sponsors
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All referrals to the transplant programme at our hospital are invariably seen by one of the investigators. All eligible patients will be offered entry into the trial at that initial visit. 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. Dose reduction of plerixafor is required where the creatinine clearance is between 30-50 mls/min. Negative pregnancy test in women of childbearing age. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Exclusion criteria are ANY of the following: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Using plerixafor plus granulocyte-colony stimulating factor (G-CSF), is the yield of stem (CD34+) cells at least as good as can be obtained with conventional chemotherapy plus G-CSF?, and can this be accomplished in the same or fewer stem cell collections (known as aphereses)? Stated more formally, the primary study endpoint is a composite of BOTH an adequate stem cell harvest (at least 4 x 10 E6 CD34+ cells per kg body weight in no more than 2 aphereses) AND a neutrophil count that never falls below 1.0 x 10 E9 / Litre in the 3 weeks following initiation of mobilisation. ; Secondary Objective: Secondary endpoints include the total stem cell yield in 1-2 aphereses, serial neutrophil and platelet counts in the blood during mobilisation, the time to neutrophil and platelet engraftment after subsequent stem cell transplantation (SCT), the usage of plerixafor and the number and timing of apheresis collections. These data will be compared to those in an immediately preceding consecutive cohort of 120 myeloma and lymphoma patients mobilised with chemotherapy plus G-CSF. This comparator population is suitable, as the case mix and induction therapies are unlikely to change significantly from that of the control group during the period of the study. ; Primary end point(s): The primary study endpoint is a composite of BOTH an adequate stem cell harvest (at least 4 x 10 E6 CD34+ cells per kg body weight in no more than 2 aphereses) AND a neutrophil count that never falls below 1.0 x 10 E9 / Litre in the 3 weeks following initiation of mobilisation. | — |
Countries
United Kingdom
Outcome results
None listed