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Journal Articles

Trial in Progress: Phase 2 Study of Subcutaneous Isatuximab, Administered By an on-Body Delivery System, in Combination with Weekly Carfilzomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (SubQSA)

Tondre T. Buck, Clark Cutrer, Nashat Y. Gabrail, George F. Geils, Jr., Alexander Philipovskiy, Hayman S. Salib, Yvonne Barnes, Pamela Brill, Taro Fukao, Florence Leroy-Carita, Jesús G Berdeja

Blood (2024) 144 (Supplement 1): 4757.2.

https://doi.org/10.1182/blood-2024-203880

Published: 2024

Journal Articles

Reclassification of Ascertain (ASTX727-02) Myelodysplastic Syndrome (MDS) Patients: Outcomes Including Clinical Response, Overall Survival (OS), and Leukemia Free Survival (LFS) Based on IPSS-R and IPSS-M Scoring Systems

Blood (2023) 142 (Supplement 1): 4619.

https://doi.org/10.1182/blood-2023-188258

Published: 2023

Journal Articles

Prolonged Survival in Bi-Allelic TP53 -Mutated ( TP53 mut) MDS Subjects Treated with Oral Decitabine/Cedazuridine in the Ascertain Trial (ASTX727-02)

Blood (2022) 140 (Supplement 1): 2066–2069.

https://doi.org/10.1182/blood-2022-163841

Published: 2022

Journal Articles

Oral Decitabine/Cedazuridine in Patients with Lower Risk Myelodysplastic Syndrome: A Longer-Term Follow-up of from the Ascertain Study

Blood (2021) 138 (Supplement 1): 66.

https://doi.org/10.1182/blood-2021-144648

Published: 2021

Journal Articles

Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine

Blood (2019) 134 (Supplement_1): 846.

https://doi.org/10.1182/blood-2019-122980

Published: 2019

Journal Articles

A Phase 1-2 Dose-Escalation and Cohort- Expansion Study of eFT508, a Selective, Orally Bioavailable Inhibitor of MNK1 and MNK2, in Patients with Hematological Malignancies

Ajay K. Gopal, MD, Rod Ramchandren, MD, Nashat Y. Gabrail, Manish R Patel, MD, Ding Wang, MDPhD, Langdon L Miller, MD, Vikas Goel, PhD, Gary G Chiang, PhD, Kevin R Webster, PhD, Sam Sperry, PhD, Debra T Vallner, PhDMBA, Cara Casseday, BSc MBA, Jeremy Barton, MBBS

Blood (2017) 130 (Supplement 1): 4624.

https://doi.org/10.1182/blood.V130.Suppl_1.4624.4624

Published: 2017

Journal Articles

Comparison of Proteasome Inhibition Activity between Carfilzomib and Bortezomib in the Phase 3 Endeavor Study

Heinz Ludwig, MD, Andrew Spencer, MD, Tibor Kovacsovics, Nashat Y. Gabrail, Leonard Minuk, Amy S. Kimball, Robert J. Pelham, Ying C. Ou, Robert Z. Orlowski, MD PhD

Blood (2017) 130 (Supplement 1): 3125.

https://doi.org/10.1182/blood.V130.Suppl_1.3125.3125

Published: 2017

Journal Articles

Selective HDAC6 Inhibitor ACY-241, an Oral Tablet, Combined with Pomalidomide and Dexamethasone: Safety and Efficacy of Escalation and Expansion Cohorts in Patients with Relapsed or Relapsed-and-Refractory Multiple Myeloma (ACE-MM-200 Study)

Blood (2016) 128 (22): 3307.

https://doi.org/10.1182/blood.V128.22.3307.3307

Published: 2016

Journal Articles

An Open-Label, Phase 1 Study Evaluating the Safety and Pharmacokinetics of Pralatrexate in Relapsed/Refractory Advanced Solid Tumors or Advanced Lymphoma/Myeloma Patients with Mild, Moderate, and Severe Renal Impairment

Kevin R. Kelly, MD PhD, Nashat Y. Gabrail, MD, William J Edenfield, MD, A Craig Lockhart, Anthony J. Olszanski, MDPhD, Guru Reddy

Blood (2015) 126 (23): 3966.

https://doi.org/10.1182/blood.V126.23.3966.3966

Published: 2015

Journal Articles

Safety, Efficacy, and Determination of the Recommended Phase 2 Dose for the Oral Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330)

Blood (2015) 126 (23): 258.

https://doi.org/10.1182/blood.V126.23.258.258

Published: 2015

Journal Articles

ACY-241, a Novel, HDAC6 Selective Inhibitor: Synergy with Immunomodulatory (IMiD®) Drugs in Multiple Myeloma (MM) Cells and Early Clinical Results (ACE-MM-200 Study)

Ruben Niesvizky, MD, Paul G. Richardson, MD, Nashat Y. Gabrail, MD, Sumit Madan, MD, Andrew J. Yee, MD, Steven N Quayle, PhD, Ingrid Almeciga-Pinto, PhD, Simon S Jones, PhD, Lee Houston, Denise Hayes, John Van Duzer, PhD, Catherine Wheeler, MD, Nikolaus S. Trede, MD PhD, Noopur S. Raje, MD

Blood (2015) 126 (23): 3040.

https://doi.org/10.1182/blood.V126.23.3040.3040

Published: 2015

Journal Articles

Long-Term Follow Up Of a Randomized Phase II Study Of The JAK2-Selective Inhibitor Fedratinib (SAR302503) In Patients With Myelofibrosis (MF)

Animesh Pardanani, MBBS, PhD, Ayalew Tefferi, MD, Catriona HM Jamieson, MD, PhD, Nashat Y Gabrail, MD MRCP, Claudia Lebedinsky, MD, Guozhi Gao, PhD, Moshe Talpaz, MD

Blood (2013) 122 (21): 4047.

https://doi.org/10.1182/blood.V122.21.4047.4047

Published: 2013

Journal Articles

Preliminary Evidence Of Anti Tumor Activity Of Selinexor (KPT-330) In a Phase I Trial Ofa First-In-Class Oral Selective Inhibitor Of Nuclear Export (SINE) In Patients (pts) With Relapsed / Refractory Non Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

Blood (2013) 122 (21): 90.

https://doi.org/10.1182/blood.V122.21.90.90

Published: 2013

Journal Articles

A Phase II Randomized Dose-Ranging Study of the JAK2-Selective Inhibitor SAR302503 in Patients with Intermediate-2 or High-Risk Primary Myelofibrosis (MF), Post-Polycythemia Vera (PV) MF, or Post-Essential Thrombocythemia (ET) MF.

Moshe Talpaz, MD, Catriona Jamieson, MD, PhD, Nashat Y Gabrail, MD, Claudia Lebedinsky, MD, Guozhi Gao, PhD, Feng Liu, PhD, Ayalew Tefferi, MD, Animesh Pardanani, MBBS, PhD

Blood (2012) 120 (21): 2837.

https://doi.org/10.1182/blood.V120.21.2837.2837

Published: 2012

Journal Articles

An open-label, single-arm, phase 2 (PX-171-004) study of single-agent carfilzomib in bortezomib-naive patients with relapsed and/or refractory multiple myeloma

Blood (2012) 119 (24): 5661–5670.

https://doi.org/10.1182/blood-2012-03-414359

Published: 2012

Journal Articles

Randomized Open-Label Phase II Study of Decitabine in Patients with Low- or Intermediate-1 Risk Myelodysplastic Syndromes,

Guillermo Garcia-Manero, Elias Jabbour, Gautam Borthakur, Stefan Faderl, MD, Zeev Estrov, Lucy Godley, MD, PhD, Nashat Y. Gabrail, MD, Jesus G. Berdeja, MD, Ahmed Nadeem, MD, Karen Stein, MD, MPH, Yvonne Noble, RN, BS, Laurent Kassalow, MS, Hagop M. Kantarjian, MD

Blood (2011) 118 (21): 3812.

https://doi.org/10.1182/blood.V118.21.3812.3812

Published: 2011

Journal Articles

A 2-Part Phase I Study in Patients with Solid or Hematologic Malignancies: Dose Proportionality of Subcutaneous (SC) Azacitidine (AZA) and Pharmacokinetics of SC AZA in Patients with Severe Renal Impairment,

Eric Laille, MS, Alain C. Mita, MD, Sanjay Goel, MD, MS, Nashat Y. Gabrail, MD, Joseph Schwarz, MBA, CL Beach, PharmD

Blood (2011) 118 (21): 3480.

https://doi.org/10.1182/blood.V118.21.3480.3480

Published: 2011

Journal Articles

Final Results From the Bortezomib-naïve Group of PX-171-004, a Phase 2 Study of Single-Agent Carfilzomib in Patients with Relapsed and/or Refractory MM

Blood (2011) 118 (21): 813.

https://doi.org/10.1182/blood.V118.21.813.813

Published: 2011

Journal Articles

Patient-Reported Quality of Life In Elderly, Newly Diagnosed Multiple Myeloma Patients Treated with Bortezomib-Based Regimens: Results From the Phase 3b UPFRONT Study

Ruben Niesvizky, MD, Ian W. Flinn, MD, PhD, Robert M. Rifkin, MD, Nashat Y Gabrail, MD, Veena Charu, MD, Billy Clowney, MD, James Essell, MD, Yousuf A Gaffar, MD, Thomas A. Warr, MD, Rachel Neuwirth, MS, Deyanira Corzo, MD, James A Reeves, MD

Blood (2010) 116 (21): 3026.

https://doi.org/10.1182/blood.V116.21.3026.3026

Published: 2010

Journal Articles

Carfilzomib: High Single Agent Response Rate with Minimal Neuropathy Even In High-Risk Patients

Ravi Vij, MBBS, MD, Jonathan L. Kaufman, MD, Andrzej J Jakubowiak, MD, PhD, A. Keith Stewart, MBChB, Sundar Jagannath, MD, Vishal Kukreti, MD, FRCPC, Kevin T. McDonagh, MD, Melissa Alsina, MD, Nizar J Bahlis, MD, Andrew Belch, MD, Frederic J. Reu, MD, Nashat Y Gabrail, MD, Jeffrey Matous, MD, David H. Vesole, MD, PhD, Robert Z. Orlowski, MD, PhD, Mai H. Le, MD, Peter Lee, MD, PhD, Michael Wang, MD, The MMRC

Blood (2010) 116 (21): 1938.

https://doi.org/10.1182/blood.V116.21.1938.1938

Published: 2010

NARROW

Trial in Progress: Phase 2 Study of Subcutaneous Isatuximab, Administered By an on-Body Delivery System, in Combination with Weekly Carfilzomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (SubQSA)

Reclassification of Ascertain (ASTX727-02) Myelodysplastic Syndrome (MDS) Patients: Outcomes Including Clinical Response, Overall Survival (OS), and Leukemia Free Survival (LFS) Based on IPSS-R and IPSS-M Scoring Systems

Prolonged Survival in Bi-Allelic TP53 -Mutated ( TP53 mut) MDS Subjects Treated with Oral Decitabine/Cedazuridine in the Ascertain Trial (ASTX727-02)

Oral Decitabine/Cedazuridine in Patients with Lower Risk Myelodysplastic Syndrome: A Longer-Term Follow-up of from the Ascertain Study

Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine

A Phase 1-2 Dose-Escalation and Cohort- Expansion Study of eFT508, a Selective, Orally Bioavailable Inhibitor of MNK1 and MNK2, in Patients with Hematological Malignancies

Comparison of Proteasome Inhibition Activity between Carfilzomib and Bortezomib in the Phase 3 Endeavor Study

Selective HDAC6 Inhibitor ACY-241, an Oral Tablet, Combined with Pomalidomide and Dexamethasone: Safety and Efficacy of Escalation and Expansion Cohorts in Patients with Relapsed or Relapsed-and-Refractory Multiple Myeloma (ACE-MM-200 Study)

An Open-Label, Phase 1 Study Evaluating the Safety and Pharmacokinetics of Pralatrexate in Relapsed/Refractory Advanced Solid Tumors or Advanced Lymphoma/Myeloma Patients with Mild, Moderate, and Severe Renal Impairment

Safety, Efficacy, and Determination of the Recommended Phase 2 Dose for the Oral Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330)

ACY-241, a Novel, HDAC6 Selective Inhibitor: Synergy with Immunomodulatory (IMiD®) Drugs in Multiple Myeloma (MM) Cells and Early Clinical Results (ACE-MM-200 Study)

Long-Term Follow Up Of a Randomized Phase II Study Of The JAK2-Selective Inhibitor Fedratinib (SAR302503) In Patients With Myelofibrosis (MF)

Preliminary Evidence Of Anti Tumor Activity Of Selinexor (KPT-330) In a Phase I Trial Ofa First-In-Class Oral Selective Inhibitor Of Nuclear Export (SINE) In Patients (pts) With Relapsed / Refractory Non Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

A Phase II Randomized Dose-Ranging Study of the JAK2-Selective Inhibitor SAR302503 in Patients with Intermediate-2 or High-Risk Primary Myelofibrosis (MF), Post-Polycythemia Vera (PV) MF, or Post-Essential Thrombocythemia (ET) MF.

An open-label, single-arm, phase 2 (PX-171-004) study of single-agent carfilzomib in bortezomib-naive patients with relapsed and/or refractory multiple myeloma

Randomized Open-Label Phase II Study of Decitabine in Patients with Low- or Intermediate-1 Risk Myelodysplastic Syndromes,

A 2-Part Phase I Study in Patients with Solid or Hematologic Malignancies: Dose Proportionality of Subcutaneous (SC) Azacitidine (AZA) and Pharmacokinetics of SC AZA in Patients with Severe Renal Impairment,

Final Results From the Bortezomib-naïve Group of PX-171-004, a Phase 2 Study of Single-Agent Carfilzomib in Patients with Relapsed and/or Refractory MM

Patient-Reported Quality of Life In Elderly, Newly Diagnosed Multiple Myeloma Patients Treated with Bortezomib-Based Regimens: Results From the Phase 3b UPFRONT Study

Carfilzomib: High Single Agent Response Rate with Minimal Neuropathy Even In High-Risk Patients

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American Society of Hematology

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