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Article: CYP3A5

Seligson, Nathan D / Zhang, Xunjie / Zemanek, Mark C / Johnson, Jasmine A / VanGundy, Zachary / Wang, Danxin / Phelps, Mitch A / Roddy, Julianna / Hofmeister, Craig C / Li, Junan / Poi, Ming J

Frontiers in pharmacology

2024 Volume 14, Page(s) 1334440

Abstract: Introduction: ...

Abstract	Introduction:
Language	English
Publishing date	2024-01-08
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2023.1334440
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Article ; Online: How to Integrate Elotuzumab and Daratumumab Into Therapy for Multiple Myeloma.

Hofmeister, Craig C / Lonial, Sagar

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2016 Volume 34, Issue 36, Page(s) 4421–4430

Abstract: Purpose Treatment options and outcomes for patients with multiple myeloma have dramatically improved over the past decade with new agents and drug targets for patients at all stages of disease. Incorporation of newly approved monoclonal antibodies is a ... ...

Abstract	Purpose Treatment options and outcomes for patients with multiple myeloma have dramatically improved over the past decade with new agents and drug targets for patients at all stages of disease. Incorporation of newly approved monoclonal antibodies is a clinical challenge because the trials used to gain approval are relatively limited in scope and may be less helpful for patients treated in the United States. This article will review data on the use of elotuzumab and daratumumab and provide a foundation for their use in current clinical practice. Methods We performed a review of current published articles and abstract data from clinical trials as well as data on managing adverse events. Results Single-agent activity was seen when using daratumumab in refractory myeloma, and trials for both elotuzumab and daratumumab have demonstrated significant activity when combined with proteasome inhibitors and immunomodulatory agents. Unique antibody-related adverse events and challenges are reviewed and discussed. Conclusion These antibodies already have had and will continue to have a dramatic impact on myeloma treatment. Combination therapy likely represents the best approach for their use, and trials that evaluate optimal timing and duration of therapy are in progress as part of induction, salvage, and maintenance therapy.
MeSH term(s)	Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Clinical Trials, Phase I as Topic ; Clinical Trials, Phase II as Topic ; Disease-Free Survival ; Female ; Humans ; Male ; Multiple Myeloma/drug therapy ; Multiple Myeloma/mortality ; Multiple Myeloma/pathology ; Neoplasm Invasiveness/pathology ; Neoplasm Staging ; Prognosis ; Randomized Controlled Trials as Topic ; Risk Assessment ; Survival Analysis ; Treatment Outcome
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; elotuzumab (1351PE5UGS) ; daratumumab (4Z63YK6E0E)
Language	English
Publishing date	2016-10-31
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.2016.69.5908
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Article ; Online: Registering a CD38 antibody upfront for multiple myeloma.

Hofmeister, Craig C / Nooka, Ajay / Kaufman, Jonathan L / Lonial, Sagar

Lancet (London, England)

2019 Volume 394, Issue 10192, Page(s) 3–4

MeSH term(s)	Antibodies, Monoclonal ; Bortezomib ; Cell Transplantation ; Dexamethasone ; Humans ; Multiple Myeloma ; Thalidomide
Chemical Substances	Antibodies, Monoclonal ; daratumumab (4Z63YK6E0E) ; Thalidomide (4Z8R6ORS6L) ; Bortezomib (69G8BD63PP) ; Dexamethasone (7S5I7G3JQL)
Language	English
Publishing date	2019-06-03
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	3306-6
ISSN	1474-547X ; 0023-7507 ; 0140-6736
ISSN (online)	1474-547X
ISSN	0023-7507 ; 0140-6736
DOI	10.1016/S0140-6736(19)31250-4
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Article ; Online: Eliminating the monitoring period with subcutaneous daratumumab: a single-center experience.

Maples, Kathryn T / Hall, Kevin H / Joseph, Nisha S / Hofmeister, Craig C / Gupta, Vikas / Dhodapkar, Madhav V / Kaufman, Jonathan L / Nooka, Ajay K / Lonial, Sagar

Blood cancer journal

2023 Volume 13, Issue 1, Page(s) 29

MeSH term(s)	Humans ; Multiple Myeloma ; Antibodies, Monoclonal/therapeutic use
Chemical Substances	daratumumab (4Z63YK6E0E) ; Antibodies, Monoclonal
Language	English
Publishing date	2023-02-20
Publishing country	United States
Document type	Letter
ZDB-ID	2600560-8
ISSN	2044-5385 ; 2044-5385
ISSN (online)	2044-5385
ISSN	2044-5385
DOI	10.1038/s41408-023-00801-1
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Article ; Online: Impact of Black Race on Peripheral Neuropathy in Patients With Newly Diagnosed Multiple Myeloma Receiving Bortezomib Induction.

Sun, Laura F / Maples, Kathryn T / Hall, Kevin H / Liu, Yuan / Cao, Yichun / Joseph, Nisha S / Hofmeister, Craig C / Kaufman, Jonathan L / Dhodapkar, Madhav / Nooka, Ajay K / Lonial, Sagar / Harvey, R Donald

JCO oncology practice

2023 Volume 19, Issue 9, Page(s) 793–798

Abstract: Purpose: The incidence of multiple myeloma (MM) is two to three times higher in Black patients compared with other races, making it the most common hematologic malignancy in this patient population. Current treatment guidelines recommend the combination ...

Abstract	Purpose: The incidence of multiple myeloma (MM) is two to three times higher in Black patients compared with other races, making it the most common hematologic malignancy in this patient population. Current treatment guidelines recommend the combination of a proteasome inhibitor, an immunomodulatory agent, and a corticosteroid as preferred induction therapy. Bortezomib use comes with the risk of peripheral neuropathy (PN) and potential need for dose reduction, therapy interruption, and additional supportive medications. Known risk factors for bortezomib-induced peripheral neuropathy (BIPN) include diabetes mellitus, previous thalidomide, advanced age, and obesity. We aimed to determine the potential association between Black race and incidence of BIPN. Patients and methods: We identified a cohort of 748 patients with newly diagnosed MM who received induction with bortezomib, lenalidomide, and dexamethasone from 2007 to 2016. One hundred forty Black patients were matched with 140 non-Black patients on age, sex, BMI, and route of bortezomib administration. Incidence of BIPN was a binary event defined as new use of a neuropathy medication, bortezomib dose reduction, dose omission, or discontinuation because of PN. Results: The incidence of BIPN was higher in Black patients (46%) compared with non-Black patients (34%; Conclusion: These data indicate that Black race is an independent risk factor for the development of BIPN. Additional prevention strategies, close monitoring, and appropriate supportive care measures are warranted for these patients.
MeSH term(s)	Humans ; Bortezomib/adverse effects ; Lenalidomide/adverse effects ; Multiple Myeloma/complications ; Multiple Myeloma/drug therapy ; Multiple Myeloma/ethnology ; Peripheral Nervous System Diseases/chemically induced ; Peripheral Nervous System Diseases/ethnology ; Thalidomide/adverse effects ; Black or African American
Chemical Substances	Bortezomib (69G8BD63PP) ; Lenalidomide (F0P408N6V4) ; Thalidomide (4Z8R6ORS6L)
Language	English
Publishing date	2023-07-07
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	3028198-2
ISSN	2688-1535 ; 2688-1527
ISSN (online)	2688-1535
ISSN	2688-1527
DOI	10.1200/OP.22.00781
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Article ; Online: Prophylactic tocilizumab to prevent cytokine release syndrome (CRS) with teclistamab: A single-center experience.

Scott, Sara A / Marin, Ellen M / Maples, Kathryn T / Joseph, Nisha S / Hofmeister, Craig C / Gupta, Vikas A / Dhodapkar, Madhav V / Kaufman, Jonathan L / Lonial, Sagar / Nooka, Ajay K

Blood cancer journal

2023 Volume 13, Issue 1, Page(s) 191

MeSH term(s)	Humans ; Cytokine Release Syndrome ; Cytokines ; Antibodies, Monoclonal, Humanized/therapeutic use
Chemical Substances	tocilizumab (I031V2H011) ; Cytokines ; Antibodies, Monoclonal, Humanized
Language	English
Publishing date	2023-12-20
Publishing country	United States
Document type	Letter
ZDB-ID	2600560-8
ISSN	2044-5385 ; 2044-5385
ISSN (online)	2044-5385
ISSN	2044-5385
DOI	10.1038/s41408-023-00963-y
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Article ; Online: PARP1

Thomas, Melissa / Li, Junan / King, Kevan / Persaud, Avinash K / Duah, Ernest / Vangundy, Zachary / Hofmeister, Craig C / Lamba, Jatinder K / Tan, Aik Choon / Fridley, Brooke L / Poi, Ming J / Seligson, Nathan D

Haematologica

2023 Volume 108, Issue 8, Page(s) 2155–2166

Abstract: Multiple Myeloma (MM) is an incurable plasma cell malignancy often treated by autologous stem cell transplant (ASCT). Clinical response to ASCT has been associated with DNA repair efficiency. Here we interrogated the role of the base excision DNA repair ( ...

Abstract	Multiple Myeloma (MM) is an incurable plasma cell malignancy often treated by autologous stem cell transplant (ASCT). Clinical response to ASCT has been associated with DNA repair efficiency. Here we interrogated the role of the base excision DNA repair (BER) pathway in MM response to ASCT. Across 450 clinical samples and six disease stages, expression levels of genes in the BER pathway were found to be highly upregulated during the development of MM. In a separate cohort of 559 patients with MM treated with ASCT, expression of BER pathway members MPG and PARP3 was positively associated with overall survival (OS) while expression of PARP1, POLD1, and POLD2 was negatively associated with OS. In a validation cohort of 356 patients with MM treated with ASCT, PARP1 and POLD2 findings were replicated. In patients with MM who never received ASCT (n=319), PARP1 and POLD2 were not associated with OS, suggesting that the prognostic effect of these genes may be treatment-dependent. In preclinical models of MM, synergy was observed in anti-tumor activity when poly (ADPribose) polymerase (PARP) inhibitors (olaparib, talazoparib) were used in combination with melphalan. The negative prognosis associated with PARP1 and POLD2 expression along with the apparent melphalan-sensitizing effect of PARP inhibition may suggest this pathway as a potential biomarker in patients with MM in the setting of ASCT. Further understanding of the role of the BER pathway in MM is vital to improve therapeutic strategies related to ASCT.
MeSH term(s)	Humans ; Multiple Myeloma/diagnosis ; Multiple Myeloma/genetics ; Multiple Myeloma/therapy ; Melphalan/therapeutic use ; Prognosis ; Poly(ADP-ribose) Polymerase Inhibitors/therapeutic use ; Transplantation, Autologous ; Stem Cell Transplantation ; Hematopoietic Stem Cell Transplantation ; Retrospective Studies ; Poly (ADP-Ribose) Polymerase-1/genetics ; Poly (ADP-Ribose) Polymerase-1/therapeutic use ; DNA Polymerase III
Chemical Substances	Melphalan (Q41OR9510P) ; Poly(ADP-ribose) Polymerase Inhibitors ; PARP1 protein, human (EC 2.4.2.30) ; Poly (ADP-Ribose) Polymerase-1 (EC 2.4.2.30) ; POLD2 protein, human (EC 2.7.7.-) ; DNA Polymerase III (EC 2.7.7.7)
Language	English
Publishing date	2023-08-01
Publishing country	Italy
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2022.282399
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Article ; Online: A Single Nucleotide Polymorphism (SNP) in the

Li, Junan / Persaud, Avinash K / Johnson, Jasmine A / Sborov, Dougkas W / Phelps, Mitch A / Hofmeister, Craig C / Poi, Ming J

Anticancer research

2021 Volume 42, Issue 1, Page(s) 385–395

Abstract: Background: It has been reported that expression of OCT3 enhanced the sensitivity to melphalan in cells, indicative of potential roles of OCT3 in melphalan transport. Herein we investigated the association of select single nucleotide polymorphisms in ... ...

Abstract	Background: It has been reported that expression of OCT3 enhanced the sensitivity to melphalan in cells, indicative of potential roles of OCT3 in melphalan transport. Herein we investigated the association of select single nucleotide polymorphisms in SLC22A3 (gene encoding OCT3) with clinical outcomes in multiple myeloma (MM) patients with hematopoietic autologous stem cell transplants followed by high-dose melphalan therapy. Materials and methods: Melphlan concentrations in blood samples from 108 MM patients were measured using liquid chromatography-tandem mass spectrometry (LC-MS/ΜS); genotypes of rs2048327, rs1810126, and rs3088442 in these patients were determined using quatitive RT-PCR assays. Results: Rs3088442 A variant-carriers had a significantly increased risk of severe oral mucositis in comparison with homozygous rs3088442 G-carriers with adjusted odds ratio of 4.00 (95% CI=1.25-14.7; p=0.027). Rs3088442 A carriers tended to have lower creatinine clearance (p=0.10) and higher maximum plasma concentration of melphalan (p=0.07). Conclusion: OCT3 might be involved in melphalan transport in MM patients.
MeSH term(s)	Adult ; Aged ; Genetic Association Studies ; Genetic Predisposition to Disease ; Genotype ; Humans ; Male ; Melphalan/adverse effects ; Melphalan/therapeutic use ; Middle Aged ; Multiple Myeloma/complications ; Multiple Myeloma/genetics ; Multiple Myeloma/pathology ; Multiple Myeloma/therapy ; Organic Cation Transport Proteins/genetics ; Polymorphism, Single Nucleotide/genetics ; Stem Cell Transplantation/adverse effects ; Stomatitis/epidemiology ; Stomatitis/genetics ; Stomatitis/pathology ; Transplantation, Autologous/adverse effects
Chemical Substances	Organic Cation Transport Proteins ; solute carrier family 22 (organic cation transporter), member 3 ; Melphalan (Q41OR9510P)
Language	English
Publishing date	2021-12-27
Publishing country	Greece
Document type	Journal Article
ZDB-ID	604549-2
ISSN	1791-7530 ; 0250-7005
ISSN (online)	1791-7530
ISSN	0250-7005
DOI	10.21873/anticanres.15497
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Article ; Online: Population Pharmacokinetic Analysis from First-in-Human Data for HDAC Inhibitor, REC-2282 (AR-42), in Patients with Solid Tumors and Hematologic Malignancies: A Case Study for Evaluating Flat vs. Body Size Normalized Dosing.

Liva, Sophia / Chen, Min / Mortazavi, Amir / Walker, Alison / Wang, Jiang / Dittmar, Kristin / Hofmeister, Craig / Coss, Christopher C / Phelps, Mitch A

European journal of drug metabolism and pharmacokinetics

2021 Volume 46, Issue 6, Page(s) 807–816

Abstract: Background and objectives: REC-2282 is a novel histone deacetylase inhibitor that has shown antitumor activity in in vitro and in vivo models of malignancy. The aims of this study were to characterize the population pharmacokinetics of REC-2282 (AR-42) ...

Abstract	Background and objectives: REC-2282 is a novel histone deacetylase inhibitor that has shown antitumor activity in in vitro and in vivo models of malignancy. The aims of this study were to characterize the population pharmacokinetics of REC-2282 (AR-42) from the first-in-human (NCT01129193) and phase I acute myeloid leukemia trials (NCT01798901) and to evaluate potential sources of variability. Additionally, we sought to understand alternate body size descriptors as sources of inter-individual variability (IIV), which was significant for dose-normalized maximum observed concentration and area under the concentration-time curve (AUC). Methods: Datasets from two clinical trials were combined, and population pharmacokinetic analysis was performed using NONMEM and R softwares; patient demographics were tested as covariates. Results: A successful population pharmacokinetic model was constructed. The pharmacokinetics of REC-2282 were best described by a two-compartment model with one transit compartment for absorption, first-order elimination and a proportional error model. Fat-free mass (FFM) was retained as a single covariate on clearance (CL), though it explained < 3% of the observed variability on CL. Tumor type and formulation were retained as covariates on lag time, and a majority of variability, attributed to absorption, remained unexplained. Computed tomography (CT)-derived lean body weight estimates were lower than estimated lean body weight and fat-free mass measures in most patients. Analysis of dose-normalized AUC vs. body size descriptors suggests flat dosing is most appropriate for REC-2282. Conclusions: FFM was identified as a significant covariate on CL; however, it explained only a very small portion of the IIV; major factors contributing significantly to REC-2282 pharmacokinetic variability remain unidentified.
MeSH term(s)	Adult ; Aged ; Body Size ; Female ; Hematologic Neoplasms/drug therapy ; Hematologic Neoplasms/metabolism ; Histone Deacetylase Inhibitors/pharmacokinetics ; Histone Deacetylase Inhibitors/therapeutic use ; Humans ; Male ; Middle Aged
Chemical Substances	Histone Deacetylase Inhibitors
Language	English
Publishing date	2021-10-07
Publishing country	France
Document type	Journal Article
ZDB-ID	196729-0
ISSN	2107-0180 ; 0398-7639 ; 0378-7966
ISSN (online)	2107-0180
ISSN	0398-7639 ; 0378-7966
DOI	10.1007/s13318-021-00722-z
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Article ; Online: Correction: HDAC inhibitor AR-42 decreases CD44 expression and sensitizes myeloma cells to lenalidomide.

Canella, Alessandro / Nieves, Hector Cordero / Sborov, Douglas W / Cascione, Luciano / Radomska, Hanna S / Smith, Emily / Stiff, Andrew / Consiglio, Jessica / Caserta, Enrico / Rizzotto, Lara / Zanesi, Nicola / Stefano, Volinia / Kaur, Balveen / Mo, Xiaokui / Byrd, John C / Efebera, Yvonne A / Hofmeister, Craig C / Pichiorri, Flavia

Oncotarget

2023 Volume 14, Page(s) 837–838

Language	English
Publishing date	2023-09-25
Publishing country	United States
Document type	Published Erratum
ZDB-ID	2560162-3
ISSN	1949-2553 ; 1949-2553
ISSN (online)	1949-2553
ISSN	1949-2553
DOI	10.18632/oncotarget.28515
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