Mobilisation of peripheral blood stem cells prior to autologous stem cell transplantation in patients with Non-Hodgkin’s Lymphoma (NHL), Hodgkin’s Disease (HD) or Multiple Myeloma (MM). MedDRA version: 9.1 Level: LLT Classification code 10029547 Term: Non-Hodgkin's lymphoma MedDRA version: 9.1 Level: LLT Classification code 10020206 Term: Hodgkin's disease MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Product Name: plerixafor
Product Code: AMD3100
Pharmaceutical Form: Solution for injection
INN or Proposed INN: plerixafor
CAS Number: 110078-46-1
Current Sponsor code: AMD3100
Concentration unit: mg/
Sponsors
Genzyme Europe BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria to be enrolled in the study: 1. Diagnosis of MM, NHL, or HD in partial response (PR) or complete response (CR) 2. Eligible and planned for an autologous haematopoietic stem cell transplantation 3. Written informed consent 4. At least 18 years of age (inclusive) 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 6. White blood cell (WBC) count =2.5 x 10E9/L 7. Absolute neutrophil count (ANC) =1.5 x 10E9/L 8. Platelet count =100 x 10E9/L 9. Serum creatinine equal or less than 2.2 mg/dL 10. AST/SGOT, ALT/SGPT, and total bilirubin less than 2.5 x upper limit of normal (ULN) 11. Adequate cardiac, renal, and pulmonary function sufficient to undergo apheresis and transplantation, i.e., eligible by institutional standards for autologous stem cell transplant 12. All patients must agree to use a highly effective method of contraception whilst on study treatment and for at least 3 months following plerixafor treatment (including both female patients of child-bearing potential and male patients with partners of child-bearing potential). Effective birth control includes: a) birth control pills, depot progesterone, or an intrauterine device (IUD) plus one barrier method, or b) two barrier methods. Effective barrier methods are: male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). For patients using a hormonal contraceptive method, information about any interaction of plerixafor with hormonal contraceptives is not known. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1. History of any acute or chronic leukaemia (including myelodysplastic syndrome) 2. Prior allogeneic transplantation or more than one prior autologous transplantation 3. Failed previous CD34+ cell collection attempts (either due to insufficient yield in apheresis product, or ineligible for apheresis because of inadequate mobilisation of CD34+ cells into peripheral blood) 4. Less than 4 weeks since last anti-cancer therapy (including chemotherapy, biologic/immunologic, radiation) or less than 6 weeks if prior therapy with nitrosourea or mitomycin (for therapies with long-acting agents, a treatment-free interval of at least 2 half-lives should be considered) with the exception of - Treatment with thalidomide, dexamethasone, lenalidomide (Revlimid R), and/or bortezomib (Velcade R) which is allowed up to 7 days prior to the first dose of G-CSF. 5. Bone marrow involvement >20% assessed based on the most recent bone marrow aspirate or biopsy 6. Treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilisation 7. Known to be HIV positive 8. Active hepatitis B or hepatitis C 9. Acute infection (febrile, i.e., temperature >38°C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of G-CSF 10. Hypercalcaemia as evidenced by >1 mg/dL above ULN 11. Previously received investigational therapy within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilisation phase 12. Central nervous system involvement including brain metastases or leptomeningeal disease 13. Pregnant or nursing women 14. Electrocardiogram (ECG) or study result (exercise study, scan) indicative of cardiac ischaemia or a history of clinically significant rhythm disturbance (arrhythmias), or other conduction abnormality in the last year that in the opinion of the Investigator warrants exclusion of the subject from the trial. 15. Co-morbid condition(s), which in the opinion of the Investigator, renders the patient at high risk from treatment complications or impairs their ability to comply with the study treatment and protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Confirm the safety profile of plerixafor to mobilise stem cells when used in patients with lymphoma or multiple myeloma who are eligible to undergo treatment with an autologous haematopoietic stem cell transplant;Secondary Objective: - Assess the efficacy of plerixafor and G-CSF as a mobilisation regimen as measured by the number of CD34+ cells collected in each apheresis session - Assess the clinical effectiveness of plerixafor and G-CSF mobilised stem cells by examining haematopoietic cell engraftment and graft status - Examine the influence of CD34+ cell dose infused on time to engraftment, engraftment and graft status ;Primary end point(s): Efficacy will be based on the quantity of CD34+ cells harvested and the subsequent engraftment and graft status: • Number of days to neutrophil engraftment and platelet engraftment • Increase in number of circulating CD34+ cells from time 0 to 10-11 hours after the first dose of plerixafor • Total number of CD34+ cells collected by disease type • Total number of CD34+ cells collected per apheresis day • Graft status (as measured by trilineage counts and supportive treatment, e.g., transfusion, G-CSF) at 100 days, 6 months, and 12 months following transplant | — |
Countries
Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed