An Exploratory Safety Study to Investigate the Extent of Tumor Cell Mobilization (TCM) After Use of G-CSF Alone or G-CSF Plus Plerixafor in Multiple Myeloma (MM) Patients Who May be Poor Mobilizers of Stem Cells
Phase 2
Completed
- Conditions
- Multiple Myeloma
- Interventions
- Drug: Granulocyte-colony stimulating factor (G-CSF)
- Registration Number
- NCT01753453
- Lead Sponsor
- Sanofi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description G-CSF plus plerixafor Granulocyte-colony stimulating factor (G-CSF) Patients will receive G-CSF for 4 consecutive days, then receive plerixafor before the 5th dose of G-CSF G-CSF alone Granulocyte-colony stimulating factor (G-CSF) Patients will receive G-CSF for 5 consecutive days G-CSF plus plerixafor Plerixafor Patients will receive G-CSF for 4 consecutive days, then receive plerixafor before the 5th dose of G-CSF
- Primary Outcome Measures
Name Time Method 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
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 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
- Secondary Outcome Measures
Name Time Method CD34+ stem cell yield in the apheresis product Day 1 to Day 8 of the apheresis/treatment period 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
Trial Locations
- Locations (5)
Investigational Site Number 056002
🇧🇪Brugge, Belgium
Investigational Site Number 440001
🇱🇹Vilnius, Lithuania
Investigational Site Number 233001
🇪🇪Tallinn, Estonia
Investigational Site Number 752001
🇸🇪Stockholm, Sweden
Investigational Site Number 752002
🇸🇪Umeå, Sweden