Multiple Myeloma
Conditions
Keywords
Hematopoietic stem cell transplantation, Tumour cell mobilization
Brief summary
The primary objective of this study is 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). Second objectives are to evaluate survival and disease status of G-CSF alone compared with GCSF plus plerixafor, and the efficacy and safety of G-CSF plus plerixafor when used to mobilize stem cells for autologous transplantation.
Interventions
DRUGPlerixafor
240mcg/kg, solution, subcutaneous injection
10 mcg/kg, solution, subcutaneous injection
Sponsors
Genzyme, a Sanofi Company
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of MM in partial response or complete response, who are undergo an autologous hematopoietic stem cell transplantation and could be considered potentially poor mobilizers.
Exclusion criteria
* Does not have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Has a history of any acute or chronic leukemia (including myelodysplastic syndrome). * Had prior allogeneic or autologous transplantation. * Less than 3 to 6 weeks since last anti-cancer therapy. * Chemotherapy for mobilization is not allowed. * Has bone marrow involvement \>10% assessed based on the most recent bone marrow aspirate or biopsy performed prior to first dose of G-CSF. * Was treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilization. * Has previously received plerixafor. * Is known to be HIV positive. * Has active hepatitis B or hepatitis C. * Has an acute infection within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of G-CSF. * Has hypercalcaemia as evidenced by \>1 mg/dL above upper limit of normal (ULN). * Previously received investigational therapy within 4 weeks of screening in this protocol or currently enrolled in another investigational protocol during the mobilization phase. * Has central nervous system involvement including brain metastases or leptomeningeal disease. * Has an electrocardiogram (ECG) or study result indicative of cardiac ischemia or a history of clinically significant rhythm disturbance(arrhythmias), or other conduction abnormality. * Has co-morbid condition(s), which may render the patient at high risk from treatment complications or impairs his/her ability to comply with the study treatment and protocol. * Has a white blood cell (WBC) count \<2.5 x 10\^9/L. * Has an absolute neutrophil count (ANC) \<1.5 x 10\^9/L. * Has a platelet count \<100 x 10\^9/L. * Has an estimated creatine clearance ≤50 mL/min. * Has aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), and total bilirubin ≥2.5 x ULN. * Does not have adequate cardiac, and pulmonary function sufficient to undergo apheresis and transplantation. * Pregnant or breastfeeding women. * Does not agree to use a highly effective method of contraception while on study treatment and for at least 3 months following study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients who mobilize at least 4.5x10^5 myeloma tumor cells/kg body weight as measured in each apheresis product | Day 5 to Day 8 of the apheresis/treatment period | Apheresis product parameters |
| The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/G-CSF cumulative dose/kg body weight | Day 5 to Day 8 of the apheresis/treatment period | Peripheral blood parameters |
| The change in tumor cell mobilization(TCM) in the peripheral blood | Day 4 pre-G-CSF to Day 5 pre-G-CSF | Peripheral blood parameters |
| The number of myeloma tumor cells per patient at each apheresis | Day 1 to Day 8 of the apheresis/treatment period | Apheresis product parameters |
| The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/CD34+ cells | Day 1 to Day 8 of the apheresis/treatment period | Peripheral blood parameters |
| The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/plerixafor cumulative dose/kg body weights | Day 5 to Day 8 of the apheresis/treatment period | Peripheral blood parameters |
Secondary
| Measure | Time frame |
|---|---|
| The number of patients that proceed to transplantation | Up to 2 months after final apheresis |
| Overall survival | Day 100 post transplant and up to 2 years post first-G-CSF dose |
| CD34+ stem cell yield in the apheresis product | Day 1 to Day 8 of the apheresis/treatment period |
Countries
Belgium, Estonia, Lithuania, Sweden
Outcome results
None listed