Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Multiple Myeloma Patients.
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, mobilization, G-CSF, filgrastim, cytosine arabinoside, autologous stem cell transplantation
Eligibility Criteria
Inclusion Criteria:
- Multiple myeloma patients considered eligible for tandem autologous stm cell transplantation procedure.
- Must have received at least one line of therapy including six or more cycles containing components like thalidomide, bortezomib, lenalidomide or melphalan.
- Must have achieved a partial remission (PR) or better response as assessed by International Myeloma Working Group guidelines.
- Must be 18-65 years of age.
- Must have World Health Organization performance status 0-1.
- Time form discontinuation of administration of any chemotherapy agent must be at least four weeks and immunomodulatory drug at least seven days.
- Hemoglobin level > 8 g/dl, Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count >100 x 109/L.
- Serum creatinine < 1.5 x upper limit of normal (ULN), serum bilirubin < 1.5 ULN, serum aspartate transaminase (AST/SGOT) < 2.5 x ULN, serum alanine transaminase (ALT/SGPT) < 2.5 x ULN.
- Negative human immunodeficiency virus (HIV) infection test.
- Negative pregnancy test.
- Must understand and voluntarily sign informed consent form.
Exclusion Criteria:
- Failure of prior, first-line mobilization regimen.
- Bone marrow plasma cell infiltration of above 20%.
- Administration of growth-factor other than G-CSF within 4 weeks before starting study treatment.
- Administration of G-CSF within 14 days before starting study treatment.
- Ongoing or active infection.
- Coexisting neoplasm, other than multiple myeloma.
- Pregnant or lactating females.
- Patients treated with use of autologous or allogenic stem cell transplantation in the past.
- Positive human immunodeficiency virus (HIV) infection test.
Sites / Locations
- Department of Bone Marrow Transplantation and Oncohematology, Maria Sklodowska-Curie Institute, Oncology Center, Gliwice Branch
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
G-CSF (filgrastim)
Cytosine arabinoside + G-CSF (filgrastim)
Patients will receive G-CSF(filgrastim) at 10 μg/kg per day (divided into two doses every 12 hours) subcutaneously for up to 7 days. On day 5, circulating CD34+ level will be determined. Leukapheresis will be started when the CD34+ blood level will reach at least 10/µl. If the level will be not achieved, G-CSF administration will be continued until CD34+ level will decrease compared to the preceding day. Leukaphereses will be performed using Spectra-Optia Apheresis System (TherumoBCT Inc, Lakewood, CO, USA) according to the manufacturers protocols for mononuclear cell harvesting, processing 2 total blood volumes. In case of failing to harvest targeted number of stem cells (5 × 10^6 CD34+ cells/kg), next leukapheresis can be performed on following two days (maximum 3 leukaphereses) if circulating CD34+ cell level will remain as described above.
Cytosine arabinoside will be administered as a 2-hour i.v. infusion at a dose of 0.4 g/m2 twice daily on days 1 and 2 (total dose 1.6 g/m2). G-CSF (filgrastim) 5-10 ug/kg will be started on day 5 and continued until last leukapheresis. The number of circulating CD34+ cells will be first evaluated after neutrophil recovery from nadir. Leukapheresis will be started when the CD34+ blood level will reach at least 10/µl. If the level will be not achieved, G-CSF administration will be continued until CD34+ level will decrease. Leukaphereses will be performed using Spectra-Optia Apheresis System (TherumoBCT Inc, Lakewood, CO, USA) according to the manufacturers protocols for mononuclear cell harvesting, processing 2 total blood volumes. In case of failing to harvest targeted number of stem cells (5 × 10^6 CD34+ cells/kg), next leukapheresis can be performed on following two days (maximum 3 leukaphereses) if circulating CD34+ cell level will remain as described above.