Phase II study of novel CXCR2 agonist and Plerixafor for rapid stem cell mobilization in patients with multiple myeloma

被引:1
作者
Sidana, Surbhi [1 ]
Bankova, Andriyana K. [1 ,2 ]
Hosoya, Hitomi [1 ]
Kumar, Shaji K. [3 ]
Holmes, Tyson H. [4 ]
Tamaresis, John [5 ]
Le, Anne [1 ,6 ]
Muffly, Lori S. [1 ]
Maysel-Auslender, Sofia [4 ]
Johnston, Laura [1 ]
Arai, Sally [1 ]
Lowsky, Robert [1 ]
Meyer, Everett [1 ]
Rezvani, Andrew [1 ]
Weng, Wen-Kai [1 ]
Frank, Matthew J. [1 ]
Shiraz, Parveen [1 ]
Maecker, Holden T. [4 ]
Lu, Ying [5 ]
Miklos, David B. [1 ]
Shizuru, Judith A. [1 ]
机构
[1] Stanford Univ, Sch Med, Dept Med, Div BMT & Cell Therapy, Stanford, CA 94305 USA
[2] Natl Specialized Hosp Hematol Dis, Sofia, Bulgaria
[3] Mayo Clin, Div Hematol, Rochester, MN USA
[4] Stanford Univ, Sch Med, Inst Immun Transplantat & Infect, Stanford, CA USA
[5] Stanford Univ, Sch Med, Dept Biostat, Stanford, CA USA
[6] Jasper Therapeut, Stanford, CA USA
关键词
PLUS G-CSF; BLOOD; TRANSPLANTATION; SURVIVAL; LENALIDOMIDE; CYCLOPHOSPHAMIDE; ENGRAFTMENT; COLLECTION; GUIDELINES; TRIAL;
D O I
10.1038/s41408-024-01152-1
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
MGTA-145 or GRO beta T, a CXCR2 agonist, has shown promising activity for hematopoietic stem cell (HSC) mobilization with plerixafor in pre-clinical studies and healthy volunteers. Twenty-five patients with multiple myeloma enrolled in a phase 2 trial evaluating MGTA-145 and plerixafor for HSC mobilization (NCT04552743). Plerixafor was given subcutaneously followed 2 h later by MGTA-145 (0.03 mg/kg) intravenously with same day apheresis. Mobilization/apheresis could be repeated for a second day in patients who collected <6 x10(6) CD34+ cells/kg. Lenalidomide and anti-CD38 antibody were part of induction therapy in 92% (n = 23) and 24% (n = 6) of patients, respectively. Median total HSC cell yield (CD34+ cells/kg x 10(6)) was 5.0 (range: 1.1-16.2) and day 1 yield was 3.4 (range: 0.3-16.2). 88% (n = 22) of patients met the primary endpoint of collecting 2 x10(6) CD34+ cells/kg in <= two days, 68% (n = 17) in one day. Secondary endpoints of collecting 4 and 6 x 10(6) CD34+ cells/kg in <= two days were met in 68% (n = 17) and 40% (n = 10) patients. Grade 1 or 2 adverse events (AE) were seen in 60% of patients, the most common AE being grade 1 pain, usually self-limited. All 19 patients who underwent transplant with MGTA-145 and plerixafor mobilized HSCs engrafted successfully, with durable engraftment at day 100. 74% (17 of 23) of grafts with this regimen were minimal residual disease negative by next generation flow cytometry. Graft composition for HSCs and immune cells were similar to a contemporaneous cohort mobilized with G-CSF and plerixafor.
引用
收藏
页数:10
相关论文
共 42 条
[1]   Upfront plerixafor plus G-CSF versus cyclophosphamide plus G-CSF for stem cell mobilization in multiple myeloma: efficacy and cost analysis study [J].
Afifi, S. ;
Adel, N. G. ;
Devlin, S. ;
Duck, E. ;
Vanak, J. ;
Landau, H. ;
Chung, D. J. ;
Lendvai, N. ;
Lesokhin, A. ;
Korde, N. ;
Reich, L. ;
Landgren, O. ;
Giralt, S. ;
Hassoun, H. .
BONE MARROW TRANSPLANTATION, 2016, 51 (04) :546-552
[2]  
Anaka M, 2021, TRANSPL CELL THER, V27, pS374, DOI [10.1016/s2666-6367(21)00483-8, 10.1016/S2666-6367(21)00483-8, DOI 10.1016/S2666-6367(21)00483-8]
[3]   G-CSF plus preemptive plerixafor vs hyperfractionated CY plus G-CSF for autologous stem cell mobilization in multiple myeloma: effectiveness, safety and cost analysis [J].
Antar, A. ;
Otrock, Z. K. ;
Kharfan-Dabaja, M. A. ;
Ghaddara, H. A. ;
Kreidieh, N. ;
Mahfouz, R. ;
Bazarbachi, A. .
BONE MARROW TRANSPLANTATION, 2015, 50 (06) :813-817
[4]   Using Confirmatory Factor Analysis to Evaluate Construct Validity of the Brief Pain Inventory (BPI) [J].
Atkinson, Thomas M. ;
Rosenfeld, Barry D. ;
Sit, Laura ;
Mendoza, Tito R. ;
Fruscione, Mike ;
Lavene, Dawn ;
Shaw, Mary ;
Li, Yuelin ;
Hay, Jennifer ;
Cleeland, Charles S. ;
Scher, Howard I. ;
Breitbart, William S. ;
Basch, Ethan .
JOURNAL OF PAIN AND SYMPTOM MANAGEMENT, 2011, 41 (03) :558-565
[5]   The Brief Pain Inventory and Its "Pain At Its Worst in the Last 24 Hours" Item: Clinical Trial Endpoint Considerations [J].
Atkinson, Thomas M. ;
Mendoza, Tito R. ;
Sit, Laura ;
Passik, Steven ;
Scher, Howard I. ;
Cleeland, Charles ;
Basch, Ethan .
PAIN MEDICINE, 2010, 11 (03) :337-346
[6]   Lenalidomide, Bortezomib, and Dexamethasone with Transplantation for Myeloma [J].
Attal, Michel ;
Lauwers-Cances, Valerie ;
Hulin, Cyrille ;
Leleu, Xavier ;
Caillot, Denis ;
Escoffre, Martine ;
Arnulf, Bertrand ;
Macro, Margaret ;
Belhadj, Karim ;
Garderet, Laurent ;
Roussel, Murielle ;
Payen, Catherine ;
Mathiot, Claire ;
Fermand, Jean P. ;
Meuleman, Nathalie ;
Rollet, Sandrine ;
Maglio, Michelle E. ;
Zeytoonjian, Andrea A. ;
Weller, Edie A. ;
Munshi, Nikhil ;
Anderson, Kenneth C. ;
Richardson, Paul G. ;
Facon, Thierry ;
Avet-Loiseau, Herve ;
Harousseau, Jean-Luc ;
Moreau, Philippe .
NEW ENGLAND JOURNAL OF MEDICINE, 2017, 376 (14) :1311-1320
[7]   Stem Cell Mobilization and Autograft Minimal Residual Disease Negativity with Novel Induction Regimens in Multiple Myeloma [J].
Bal, Susan ;
Landau, Heather J. ;
Shah, Gunjan L. ;
Scordo, Michael ;
Dahi, Parastoo ;
Lahoud, Oscar B. ;
Hassoun, Hani ;
Hultcrantz, Malin ;
Korde, Neha ;
Lendvai, Nikoletta ;
Lesokhin, Alexander M. ;
Mailankody, Sham ;
Shah, Urvi A. ;
Smith, Eric ;
Devlin, Sean M. ;
Avecilla, Scott ;
Dogan, Ahmet ;
Roshal, Mikhail ;
Landgren, Ola ;
Giralt, Sergio A. ;
Chung, David J. .
BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION, 2020, 26 (08) :1394-1401
[8]   FACTORS THAT INFLUENCE COLLECTION AND ENGRAFTMENT OF AUTOLOGOUS PERIPHERAL-BLOOD STEM-CELLS [J].
BENSINGER, W ;
APPELBAUM, F ;
ROWLEY, S ;
STORB, R ;
SANDERS, J ;
LILLEBY, K ;
GOOLEY, T ;
DEMIRER, T ;
SCHIFFMAN, K ;
WEAVER, C ;
CLIFT, R ;
CHAUNCEY, T ;
KLARNET, J ;
MONTGOMERY, P ;
PETERSDORF, S ;
WEIDEN, P ;
WITHERSPOON, R ;
BUCKNER, CD .
JOURNAL OF CLINICAL ONCOLOGY, 1995, 13 (10) :2547-2555
[9]   Stem Cell Mobilization Yields with Daratumumab- and Lenalidomide-Containing Quadruplet Induction Therapy in Newly Diagnosed Multiple Myeloma: Findings from the MASTER and GRIFFIN Trials [J].
Chhabra, Saurabh ;
Callander, Natalie ;
Watts, Nicole L. ;
Costa, Luciano J. ;
Thapa, Bicky ;
Kaufman, Jonathan L. ;
Laubach, Jacob ;
Sborov, Douglas W. ;
Reeves, Brandi ;
Rodriguez, Cesar ;
Chari, Ajai ;
Silbermann, Rebecca ;
Anderson, Larry D., Jr. ;
Bal, Susan ;
Dhakal, Binod ;
Nathwani, Nitya ;
Shah, Nina ;
Medvedova, Eva ;
Bumma, Naresh ;
Holstein, Sarah A. ;
Costello, Caitlin ;
Jakubowiak, Andrzej ;
Wildes, Tanya M. ;
Schmidt, Timothy ;
Orlowski, Robert Z. ;
Shain, Kenneth H. ;
Cowan, Andrew J. ;
Dholaria, Bhagirathbhai ;
Cornell, R. Frank ;
Jerkins, James H. ;
Pei, Huiling ;
Cortoos, Annelore ;
Patel, Sharmila ;
Lin, Thomas S. ;
Usmani, Saad Z. ;
Richardson, Paul G. ;
Voorhees, Peter M. .
TRANSPLANTATION AND CELLULAR THERAPY, 2023, 29 (03) :174e1-174e10
[10]   Functional regulatory T cells are collected in stem cell autografts by mobilization with high-dose cyclophosphamide and granulocyte colony-stimulating factor [J].
Condomines, Maud ;
Quittet, Philippe ;
Lu, Zhao-Yang ;
Nadal, Laure ;
Latry, Pascal ;
Lopez, Ernesto ;
Baudard, Marion ;
Requirand, Guilhem ;
Duperray, Christophe ;
Schved, Jean-Francois ;
Rossi, Jean-Francois ;
Tarte, Karin ;
Klein, Bernard .
JOURNAL OF IMMUNOLOGY, 2006, 176 (11) :6631-6639