A Multi-centre, Open Label, Single-arm Study Intended to Further Investigate the Safety and Efficacy of Plerixafor as a Front-line Mobilisation Agent in Combination With G-CSF in Patients With Lymphoma or MM (Multiple Myeloma). (PREDICT)

This is an interventional treatment trial for Lymphoma (Non-Hodgkin's Lymphoma) focused on measuring Mobilisation stem cells, G-CSF Mobilisation Regimen, Lymphoma, Multiple Myeloma Read More

Inclusion Criteria:

• Diagnosis of MM, NHL, or HD in partial response (PR) or complete response (CR)
• Eligible and planned for an autologous haematopoietic stem cell transplantation
• Written informed consent
• At least 18 years of age (inclusive)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• White blood cell (WBC) count ≥2.5 x 10^9/L
• Absolute neutrophil count (ANC) ≥1.5 x 10^9 /L
• Platelet count ≥100 x 10^9/L
• Serum creatinine ≤2.2 mg/dL
• Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), and total bilirubin <2.5 x upper limit of normal (ULN)
• Adequate cardiac, renal, and pulmonary function sufficient to undergo apheresis and transplantation, i.e., eligible by institutional standards for autologous stem cell transplant
• 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 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.

Exclusion Criteria:

• History of any acute or chronic leukaemia (including myelodysplastic syndrome)
• Prior allogeneic transplantation or more than one prior autologous transplantation
• 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)
• 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®), and/or bortezomib (Velcade®) which is allowed up to 7 days prior to the first dose of G-CSF.
• Bone marrow involvement >20% assessed based on the most recent bone marrow aspirate or biopsy
• Treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilisation
• Known to be human immunodeficiency virus (HIV) positive
• Active hepatitis B or hepatitis C
• 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
• Hypercalcaemia as evidenced by >1 mg/dL above ULN
• Previously received investigational therapy within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilisation phase
• Central nervous system involvement including brain metastases or leptomeningeal disease
• Pregnant or nursing women
• 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.
• 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