Multiple Myeloma MedDRA version: 14.1 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Mozobil 20 mg/ml solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Plerixafor
CAS Number: 110078-46-1
Current Sponsor code: GZ316455
Other descriptive
Sponsors
Sanofi aventis recherche et développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a diagnosis of MM in partial or complete response, who are to undergo an autologous HSCT and could be considered potentially poor mobilizers. A potentially poor mobilizer is defined as a person who, in the judgment of the investigator prior to study entry, may not mobilize successfully for reasons such as prior lenalidomide use. 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 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: The patient does not have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. The patient has a history of any acute or chronic leukemia (including myelodysplastic syndrome). The patient had prior allogeneic or autologous transplantation. The patient is less than 3 to 6 weeks since last anti-cancer therapy. Chemotherapy for mobilization is not allowed. Note: Treatment with thalidomide, dexamethasone, lenalidomide (Revlimid®), and/or bortezomib (Velcade®) is allowed up to 7 days prior to the first dose of G-CSF. The patient has bone marrow involvement >10% assessed based on the most recent bone marrow aspirate or biopsy performed prior to first dose of G-CSF. The patient was treated with G-CSF or other cytokine within 14 days prior to the first dose of GCSF for mobilization. The patient has previously received plerixafor. The patient is known to be HIV positive. The patient has active hepatitis B or hepatitis C. The patient has an acute infection (febrile, ie, temperature >38°C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of G-CSF. The patient has hypercalcaemia as evidenced by >1 mg/dL above ULN. The patient previously received investigational therapy within 4 weeks of screening in this protocol or currently enrolled in another investigational protocol during the mobilization phase. The patient has central nervous system involvement including brain metastases or leptomeningeal disease. The patient has an electrocardiogram (ECG) or study result (exercise study, scan) indicative of cardiac ischemia 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. The patient has co-morbid condition(s), which in the opinion of the investigator, renders the patient at high risk from treatment complications or impairs his/her ability to comply with the study treatment and protocol. The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study The patient has a white blood cell (WBC) count <2.5 x _109/L. The patient has an absolute neutrophil count (ANC) <1.5 x _109/L. The patient has a platelet count <100 x 109/L. The patient has an estimated creatine clearance =50 mL/min. The patient has 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). The patient does not have adequate cardiac, and pulmonary function sufficient to undergo apheresis and transplantation, ie, eligible by institutional standards for autologous stem cell transplant. Pregnant or breastfeeding women The patient does not agree to use a highly effective method of contraception while on study treatment and for at least 3 months following study treatment (including both female patients of childbearing 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 interactio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).;Secondary Objective: To evaluate survival and disease status of G-CSF alone compared with GCSF plus plerixafor. To evaluate the efficacy and safety of G-CSF plus plerixafor when used to mobilize stem cells for autologous transplantation.;Primary end point(s): Peripheral blood parameters: 1. The percentage of myeloma tumor cells/CD34+ cells 2. The percentage of myeloma tumor cells/plerixafor cumulative dose/kg body weights 3. The percentage of myeloma tumor cells/G-CSF cumulative dose/kg body weight 4.The change in TCM in the peripheral blood Apheresis product parameters: 5. The number/volume of myeloma tumor cells per patient at each apheresis 6. The proportion of patients who mobilize at least 4.5x105 myeloma tumor cells/kg body weight as measured in each apheresis product;Timepoint(s) of evaluation of this end point: Peripheral blood parameters: Variable Day 1 to Day 8 of the Apheresis/Treatment Period : 1. The percentage of myeloma tumor cells/CD34+ cells 5. The number/volume of myeloma tumor cells per patient at each apheresis Variable Day 5 to Day 8 of the Apheresis/Treatment Period : 2. The percentage of myeloma tumor cells/plerixafor cumulative dose/kg body weights 3. The percentage of myeloma tumor cells/G-CSF cumulative dose/kg body weight 6. The proportion of patients who mobilize at least 4.5x105 myeloma tumor cells/kg body weight as measured in each apheresis product Up to Day 5 pre-G-CSF Apheresis product parameters: 4.The change in TCM in the peripheral blood | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - CD34+ stem cell yield in the apheresis product - The proportion of patients that proceed to transplantation - Overall survival;Timepoint(s) of evaluation of this end point: - CD34+ stem cell yield in the apheresis product : Variable Day 1 to Day 8 of the Apheresis/Treatment Period - The proportion of patients that proceed to transplantation : Up to two months after final apheresis - Overall survival : At day 100 post transplant and up to 2 years post first G-CSF dose | — |
Countries
Belgium, Estonia, Lithuania, Sweden
Contacts
Public ContactJean Van Rampelbergh
sanofi-aventis Belgium
Outcome results
None listed