Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Multiple Myeloma Patients.
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|ClinicalTrials.gov Identifier: NCT01908621|
Recruitment Status : Unknown
Verified July 2013 by Maria Sklodowska-Curie Institute - Oncology Center.
Recruitment status was: Recruiting
First Posted : July 25, 2013
Last Update Posted : July 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: G-CSF (filgrastim) Drug: Cytosine arabinoside + G-CSF (filgrastim)||Phase 3|
Autologous hematopoietic stem cell transplantation (autoHSCT) is a standard treatment of eligible patients suffering from multiple myeloma (MM). Tandem autoHSCT allows to further improve results of the therapy. Nowadays, 99% of the procedures are performed using peripheral blood as a source of stem cells. Hence, the crucial point is to harvest adequate number of stem cells allowing hematopoietic recovery. The number of 5 × 10^6 CD34+ cells/kg is considered the optimal level, as far as double autoHSCT is concerned. There are two main mobilization strategies being used: based on G-CSF alone or in combination with chemotherapy (cyclophosphamide (CY) at dose range 1.5-7 g/m2 is mainly used in MM setting). However, a proportion of patients (5-40%) fail to collect the minimum number of cells required. Novel agents, like plerixafor, CXCR4 inhibitor, may enable effective CD34+ cell harvest in "poor mobilizers". Nevertheless, the optimal first-line and cost-effective protocol for mobilization of hematopoietic stem cells has not been determined so far.
Randomized trials comparing chemomobilization with use of CY + G-CSF to G-CSF alone, which had been conducted so far, did not demonstrate clear advantage of addition of CY to growth factor. Intermediate-dose cytosine arabinoside (AraC), 1.6 g/m2 plus filgrastim, has been shown to produce very high efficacy as a first or second-line mobilization regimen in patients with lymphoid malignancies, including MM. In a retrospective comparison, this strategy was significantly more effective than CY + filgrastim. This suggest that the type of chemotherapy agent added to G-CSF may play role in mobilization efficacy and that the combination of AraC and G-CSF may be more effective than G-CSF used alone. The goal of current study is to verify this hypothesis in randomized controlled trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Stem Cell Mobilization Using G-CSF (Filgrastim) Alone Compared to Intermediate-dose Cytosine Arabinoside Plus G-CSF in Multiple Myeloma Patients.|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||December 2013|
Active Comparator: 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.
Drug: G-CSF (filgrastim)
Active Comparator: Cytosine arabinoside + G-CSF (filgrastim)
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.
Drug: Cytosine arabinoside + G-CSF (filgrastim)
- The proportion of patients with stem cell yield at least 5 × 10^6 CD34+ cells/kg in each treatment arm. [ Time Frame: After up to three leukaphereses (7-20 days after starting mobilization regimen). ]
- Peak level of CD34+ cells in peripheral blood (/μl). [ Time Frame: 7-20 days after starting mobilization regimen. ]
- Total number of harvested CD34+cells/kg. [ Time Frame: Ater up to three leukaphereses (7-20 days after starting mobilization regimen). ]
- Number of leukaphereses needed to harvest target amount of stem cells. [ Time Frame: 7-20 days after starting mobilization regimen. ]
- The proportion of hematologic and non-hematologic complications. [ Time Frame: 1 month ]
- Duration of neutropenia < 0.5 x10^9/L and thrombocytopenia <50 x10^9/L. [ Time Frame: 1 month ]
- Number of blood transfusions needed and number of days of antibiotics therapy. [ Time Frame: 1 month ]
- Duration of hospital stay. [ Time Frame: 1 month ]
- Time of neutrophil and platelet engraftment after autologous stem cel transplantation. [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908621
|Contact: Tomasz Czerw, MDemail@example.com|
|Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch||Recruiting|
|Gliwice, Poland, 44-101|
|Contact: Sebastian Giebel, Assoc. prof. +48322788523 firstname.lastname@example.org|
|Principal Investigator: Tomasz Czerw, MD|