Clinical trial · Interventional
Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Multiple Myeloma Patients.
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.
NCT01908621CI-TRIAL-00034614completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to compare safety and efficacy of stem cell mobilization using G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in multiple myeloma patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytosine arabinoside + G-CSF (filgrastim) | Drug | — | UNRESOLVED |
| G-CSF (filgrastim) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- G-CSF (filgrastim)
- description
- 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.
- interventionNames
- Drug: G-CSF (filgrastim)
- type
- ACTIVE_COMPARATOR
- label
- Cytosine arabinoside + G-CSF (filgrastim)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Multiple myeloma patients considered eligible for tandem autologous stm cell transplantation procedure. 2. Must have received at least one line of therapy including six or more cycles containing components like thalidomide, bortezomib, lenalidomide or melphalan. 3. Must have achieved a partial remission (PR) or better response as assessed by International Myeloma Working Group guidelines. 4. Must be 18-65 years of age. 5. Must have World Health Organization performance status 0-1. 6. Time form discontinuation of administration of any chemotherapy agent must be at least four weeks and immunomodulatory drug at least seven days. 7. Hemoglobin level \> 8 g/dl, Absolute neutrophil count (ANC) \> 1.5 x 109/L, Platelet count \>100 x 109/L. 8. 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. 9. Negative human immunodeficiency virus (HIV) infection test. 10. Negative pregnancy test. 11. Must understand and voluntarily sign informed consent form. Exclusion Criteria: 1. Failure of prior, first-line mobilization regimen. 2. Bone marrow plasma cell infiltration of above 20%. 3. Administration of growth-factor other than G-CSF within 4 weeks before starting study treatment. 4. Administration of G-CSF within 14 days before starting study treatment. 5. Ongoing or active infection. 6. Coexisting neoplasm, other than multiple myeloma. 7. Pregnant or lactating females. 8. Patients treated with use of autologous or allogenic stem cell transplantation in the past. 9. Positive human immunodeficiency virus (HIV) infection test.
References
Publications (5)
- BACKGROUNDNarayanasami U, Kanteti R, Morelli J, Klekar A, Al-Olama A, Keating C, O'Connor C, Berkman E, Erban JK, Sprague KA, Miller KB, Schenkein DP. Randomized trial of filgrastim versus chemotherapy and filgrastim mobilization of hematopoietic progenitor cells for rescue in autologous transplantation. Blood. 2001 Oct 1;98(7):2059-64. doi: 10.1182/blood.v98.7.2059. PMID 11567990
- BACKGROUNDKaranth M, Chakrabarti S, Lovell RA, Harvey C, Holder K, McConkey CC, McDonald D, Fegan CD, Milligan DW. A randomised study comparing peripheral blood progenitor mobilisation using intermediate-dose cyclophosphamide plus lenograstim with lenograstim alone. Bone Marrow Transplant. 2004 Sep;34(5):399-403. doi: 10.1038/sj.bmt.1704598. PMID 15273706
- BACKGROUNDSheppard D, Bredeson C, Allan D, Tay J. Systematic review of randomized controlled trials of hematopoietic stem cell mobilization strategies for autologous transplantation for hematologic malignancies. Biol Blood Marrow Transplant. 2012 Aug;18(8):1191-203. doi: 10.1016/j.bbmt.2012.01.008. Epub 2012 Jan 16. PMID 22261379
- BACKGROUNDKruzel T, Sadus-Wojciechowska M, Najda J, Czerw T, Glowala-Kosinska M, Holowiecki J, Giebel S. Very high efficacy of intermediate-dose cytarabine in combination with G-CSF as a second-line mobilization of hematopoietic stem cells. Int J Hematol. 2012 Aug;96(2):287-9. doi: 10.1007/s12185-012-1135-5. Epub 2012 Jul 14. No abstract available. PMID 22797877
- BACKGROUNDGiebel S, Kruzel T, Czerw T, Sadus-Wojciechowska M, Najda J, Chmielowska E, Grosicki S, Jurczyszyn A, Pasiarski M, Nowara E, Glowala-Kosinka M, Chwieduk A, Mitrus I, Smagur A, Holowiecki J. Intermediate-dose Ara-C plus G-CSF for stem cell mobilization in patients with lymphoid malignancies, including predicted poor mobilizers. Bone Marrow Transplant. 2013 Jul;48(7):915-21. doi: 10.1038/bmt.2012.269. Epub 2013 Jan 7. PMID 23292239