Clinical trial · Interventional
Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection
Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization
- 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 this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor. The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Plerixafor + Chemo and G-CSF
- description
- Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
- interventionNames
- Drug: Plerixafor
Primary outcomes (2)
- measure
- Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis
- timeFrame
- Within the first 4 days following the first dose of Plerixafor
- measure
- Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg
- timeFrame
- Within the first 4 days following the first dose of Plerixafor
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-70 years 2. Multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) patients in first or second complete or partial remission 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Up to 3 prior treatment regimens 5. Meet all eligibility requirements for autologous transplant 6. Adequate marrow function defined as white blood cells (WBC) \>3,000; ANC \>1,500/mm3; platelets \>75,000/mm3 7. Adequate renal function defined as creatinine clearance \> 30 mL/min by Cockcroft-Gault 8. Adequate liver function defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin \< 2 times upper limit of normal 9. Able to provide informed consent 10. Women not pregnant and agree to use contraception Exclusion Criteria: 1. High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease) 2. Brain metastases or carcinomatous meningitis 3. Previous treatment with high dose chemotherapy and autologous transplant 4. Previous attempt to collect B-hematopoietic progenitor cells (HPCs) following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors 5. Acute infection or unexplained fever \>38°C 6. Weight \> 175% of ideal body weight as defined by the Devine equation 7. Experimental therapy within 4 weeks 8. Cytokine administration in the previous 14 days
References
Publications (16)
- BACKGROUNDLazarus HM, Loberiza FR Jr, Zhang MJ, Armitage JO, Ballen KK, Bashey A, Bolwell BJ, Burns LJ, Freytes CO, Gale RP, Gibson J, Herzig RH, LeMaistre CF, Marks D, Mason J, Miller AM, Milone GA, Pavlovsky S, Reece DE, Rizzo JD, van Besien K, Vose JM, Horowitz MM. Autotransplants for Hodgkin's disease in first relapse or second remission: a report from the autologous blood and marrow transplant registry (ABMTR). Bone Marrow Transplant. 2001 Feb;27(4):387-96. doi: 10.1038/sj.bmt.1702796. PMID 11313668
- BACKGROUNDLemoli RM, Martinelli G, Zamagni E, Motta MR, Rizzi S, Terragna C, Rondelli R, Ronconi S, Curti A, Bonifazi F, Tura S, Cavo M. Engraftment, clinical, and molecular follow-up of patients with multiple myeloma who were reinfused with highly purified CD34+ cells to support single or tandem high-dose chemotherapy. Blood. 2000 Apr 1;95(7):2234-9. PMID 10733490
- BACKGROUNDSmith TJ, Khatcheressian J, Lyman GH, Ozer H, Armitage JO, Balducci L, Bennett CL, Cantor SB, Crawford J, Cross SJ, Demetri G, Desch CE, Pizzo PA, Schiffer CA, Schwartzberg L, Somerfield MR, Somlo G, Wade JC, Wade JL, Winn RJ, Wozniak AJ, Wolff AC. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol. 2006 Jul 1;24(19):3187-205. doi: 10.1200/JCO.2006.06.4451. Epub 2006 May 8. PMID 16682719
- BACKGROUNDSiena S, Bregni M, Brando B, Ravagnani F, Bonadonna G, Gianni AM. Circulation of CD34+ hematopoietic stem cells in the peripheral blood of high-dose cyclophosphamide-treated patients: enhancement by intravenous recombinant human granulocyte-macrophage colony-stimulating factor. Blood. 1989 Nov 1;74(6):1905-14. PMID 2478216
- BACKGROUNDCassens U, Momkvist PH, Zuehlsdorf M, Mohr M, Kienast J, Berdel WE, Sibrowski W. Kinetics of standardized large volume leukapheresis (LVL) in patients do not show a recruitment phenomenon of peripheral blood progenitor cells (PBPC). Bone Marrow Transplant. 2001 Jul;28(1):13-20. doi: 10.1038/sj.bmt.1703082. PMID 11498739