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Journal Articles

TAK-981, a First-in-Class SUMO-Activating Enzyme Inhibitor, Combined with Rituximab in Adult Patients (Pts) with CD20-Positive Relapsed/Refractory (R/R) Non-Hodgkin Lymphoma (NHL): Phase 1 Data

Sarit Assouline, Amitkumar Mehta, Tycel Phillips, Lapo Alinari, Alexey V. Danilov, Stéphane Doucet, Steven I. Park, Deborah Berg, Alejandro Gomez-Pinillos, Alonzo Martinez, Bo Chao, Allison J Berger, John Gibbs, Sharon Friedlander, Christine K. Ward, Igor Proscurshim, Brenda W. Cooper, Paolo F Caimi

Blood (2021) 138 (Supplement 1): 2488.

https://doi.org/10.1182/blood-2021-152225

Published: 2021

Journal Articles

Phase 1b/2 Study of the First-in-Class SUMO-Activating Enzyme Inhibitor TAK-981 in Combination with Monoclonal Antibodies in Patients with Triple-Class Refractory Multiple Myeloma

Blood (2021) 138 (Supplement 1): 2742.

https://doi.org/10.1182/blood-2021-148385

Published: 2021

Journal Articles

Mezagitamab Induces Immunomodulatory Effect in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Michael Abadier, PhD, Jose Estevam, MSc, Deborah Berg, RN, MSN, Eric Robert Fedyk, PhD

Blood (2020) 136 (Supplement 1): 9.

https://doi.org/10.1182/blood-2020-140527

Published: 2020

Journal Articles

The Binding of CD38 Therapeutics to Red Blood Cells and Platelets Subverts Depletion of Target Cells

Eric Robert Fedyk, BSc, MSc, PhD, Neeraja Idamakanti, BVSc MSc DVM, Jia Chen, BSc, MSc, PhD, Jose Estevam, BSc MSc, Vivian Hernandez, BSc PhD, Matthew Wagoner, BSc PhD, Mary Carsillo, BSc DVM PhD, Deborah Berg, RN, MSN, Kristina Allikmets, MD PhD, Gezim Lahu, BSc MSc PhD, Antonio Palumbo, MD

Blood (2019) 134 (Supplement_1): 3136.

https://doi.org/10.1182/blood-2019-128238

Published: 2019

Journal Articles

Primary Results from the Phase 3 Tourmaline-AL1 Trial of Ixazomib-Dexamethasone Versus Physician's Choice of Therapy in Patients (Pts) with Relapsed/Refractory Primary Systemic AL Amyloidosis (RRAL)

Angela Dispenzieri, MD, Eftathios Kastritis, Ashutosh D Wechalekar, MB BS, MD FRCP, FRCPath, DM, Stefan O. Schönland, MD, Kihyun Kim, MD, Vaishali Sanchorawala, MD, Heather J Landau, MD, Fiona Kwok, FRACP,FRCPA,MBBS, Kenshi Suzuki, MD PhD, Raymond L Comenzo, MD, Deborah Berg, RN, MSN, Guohui Liu, PhD, Douglas V. Faller, MD PhD, Giampaolo Merlini, MD

Blood (2019) 134 (Supplement_1): 139.

https://doi.org/10.1182/blood-2019-124409

Published: 2019

Journal Articles

Preliminary Results from a Phase 1b Study of TAK-079, an Investigational Anti-CD38 Monoclonal Antibody (mAb) in Patients with Relapsed/ Refractory Multiple Myeloma (RRMM)

Amrita Y. Krishnan, MD, Krina K. Patel, MD MSc, Parameswaran Hari, MBBS, MD, Sundar Jagannath, MD, Ruben Niesvizky, MD, Rebecca W. Silbermann, MD, Deborah Berg, RN, MSN, Jianchang Lin, PhD, Eric Robert Fedyk, BSc, MSc, PhD, Antonio Palumbo, MD, Keith E. Stockerl-Goldstein, MD

Blood (2019) 134 (Supplement_1): 140.

https://doi.org/10.1182/blood-2019-128007

Published: 2019

Journal Articles

A Single Administration of the Cytolytic CD38 Antibody TAK-079 to Healthy Subjects: Tolerability, Pharmacokinetics and Pharmacodynamics

Eric Robert Fedyk, PhD, Deborah Berg, RN, MSN, Glenda Smithson, PhD, Jose Estevam, Lachy Mclean, MD PhD, Kristina Allikmets, MD PhD, Antonio Palumbo, MD

Blood (2018) 132 (Supplement 1): 3249.

https://doi.org/10.1182/blood-2018-99-112916

Published: 2018

Journal Articles

Addition of Ixazomib to an Rd Backbone Improves Clinical Benefit in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (Pts) with Non-Canonical NF-KB Activation — Results from the Tourmaline-MM1 Study

Ajeeta B Dash, PhD, Jacob Zhang, PhD, Lei Shen, PhD, Bin Li, PhD, Deborah Berg, RN, MSN, Jianchang Lin, PhD, Hervé Avet-Loiseau, MDPhD, Nizar Bahlis, MD, Philippe Moreau, Paul Richardson, Alessandra Di Bacco, PhD

Blood (2018) 132 (Supplement 1): 473.

https://doi.org/10.1182/blood-2018-99-114614

Published: 2018

Journal Articles

Overall Survival (OS) Benefit of Oral Ixazomib in Combination with Lenalidomide and Dexamethasone (IRd) Vs Lenalidomide and Dexamethasone (Rd) in Asian Patients (pts) with Relapsed and/or Refractory Multiple Myeloma (RRMM): Pooled-Analysis from the Tourmaline-MM1 and the China Continuation Studies

Blood (2018) 132 (Supplement 1): 5637.

https://doi.org/10.1182/blood-2018-99-116844

Published: 2018

Journal Articles

Ixazomib significantly prolongs progression-free survival in high-risk relapsed/refractory myeloma patients

Blood (2017) 130 (24): 2610–2618.

https://doi.org/10.1182/blood-2017-06-791228

Published: 2017

Includes: Supplemental data

Journal Articles

Efficacy and Safety of Long-Term Ixazomib Maintenance Therapy in Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) Not Undergoing Transplant: An Integrated Analysis of Four Phase 1/2 Studies

Meletios A. Dimopoulos, Jacob Laubach, MD, Maria Asuncion Echeveste Gutierrez, Norbert Grząśko, Craig C Hofmeister, MDMPH, Jesus F. San Miguel, MD, Shaji K Kumar, MD, Vickie Lu, PhD, Zhaoyang Teng, PhD, Guohui Liu, PhD, Catriona Byrne, RN, Deborah Berg, RN, MSN, Richard Labotka, MD MS, Helgi van de Velde, MD PhD, Paul G Richardson, MD

Blood (2017) 130 (Supplement 1): 902.

https://doi.org/10.1182/blood.V130.Suppl_1.902.902

Published: 2017

Journal Articles

A phase 1/2 study of the oral proteasome inhibitor ixazomib in relapsed or refractory AL amyloidosis

Vaishali Sanchorawala, Giovanni Palladini, Vishal Kukreti, Jeffrey A. Zonder, Adam D. Cohen, David C. Seldin, Angela Dispenzieri, Arnaud Jaccard, Stefan O. Schönland, Deborah Berg, Huyuan Yang, Neeraj Gupta, Ai-Min Hui, Raymond L. Comenzo, Giampaolo Merlini

Blood (2017) 130 (5): 597–605.

https://doi.org/10.1182/blood-2017-03-771220

Published: 2017

Journal Articles

Higher c-MYC Expression Is Associated with Ixazomib-Lenalidomide-Dexamethasone (IRd) Progression-Free Survival (PFS) Benefit Versus Placebo-Rd: Biomarker Analysis of the Phase 3 Tourmaline-MM1 Study in Relapsed/Refractory Multiple Myeloma (RRMM)

Blood (2016) 128 (22): 243.

https://doi.org/10.1182/blood.V128.22.243.243

Published: 2016

Journal Articles

Longer Time to Best Response and Depth of Response Are Associated with Improved Duration of Best Achieved Response and Progression-Free Survival (PFS): Post-Hoc Analysis of Phase 3 Tourmaline-MM1 Trial in Relapsed/Refractory Multiple Myeloma (RRMM)

Laurent Garderet, MD PhD, Jacob P. Laubach, MD, Anne-Marie Stoppa, MD, Parameswaran Hari, MD MRCP, MS, Michele Cavo, MD, Heinz Ludwig, MD, Maria-Victoria Mateos, MD PhD, Katarina Luptakova, Jianchang Lin, PhD, Helgi van de Velde, MD PhD, Deborah Berg, RN, MSN, Philippe Moreau, Paul G. Richardson, MD

Blood (2016) 128 (22): 2134.

https://doi.org/10.1182/blood.V128.22.2134.2134

Published: 2016

Journal Articles

Ixazomib, an Investigational Oral Proteasome Inhibitor (PI), in Combination with Lenalidomide and Dexamethasone (IRd), Significantly Extends Progression-Free Survival (PFS) for Patients (Pts) with Relapsed and/or Refractory Multiple Myeloma (RRMM): The Phase 3 Tourmaline-MM1 Study (NCT01564537)

Blood (2015) 126 (23): 727.

https://doi.org/10.1182/blood.V126.23.727.727

Published: 2015

Journal Articles

Long-Term Outcome of a Phase 1 Study of the Investigational Oral Proteasome Inhibitor (PI) Ixazomib at the Recommended Phase 3 Dose (RP3D) in Patients (Pts) with Relapsed or Refractory Systemic Light-Chain (AL) Amyloidosis (RRAL)

Giampaolo Merlini, MD, Vaishali Sanchorawala, MD, Zonder A Jeffrey, MD, Vishal Kukreti, MD FRCPC, Stefan O Schoenland, MD, Arnaud Jaccard, MD, Angela Dispenzieri, MD, Adam D. Cohen, MD, Deborah Berg, RN, MSN, Zheng Yuan, PhD, Ai-Min Hui, MD PhD, Palladini Giovanni, MD PhD, Raymond L. Comenzo, MD

Blood (2014) 124 (21): 3450.

https://doi.org/10.1182/blood.V124.21.3450.3450

Published: 2014

Journal Articles

Long-Term Ixazomib Maintenance Is Tolerable and Improves Depth of Response Following Ixazomib-Lenalidomide-Dexamethasone Induction in Patients (Pts) with Previously Untreated Multiple Myeloma (MM): Phase 2 Study Results

Shaji Kumar, MD, Jesus G. Berdeja, MD, Ruben Niesvizky, MD, Sagar Lonial, MD, Jacob P. Laubach, MD, Mehdi Hamadani, MD, A. Keith Stewart, MD, Parameswaran N. Hari, MD, Vivek Roy, MD, Robert Vescio, MD, Jonathan L. Kaufman, MD, Deborah Berg, RN, MSN, Eileen Liao, PhD, Ai-Min Hui, MD PhD, S. Vincent Rajkumar, MD, Paul G. Richardson

Blood (2014) 124 (21): 82.

https://doi.org/10.1182/blood.V124.21.82.82

Published: 2014

Journal Articles

Phase 1 study of twice-weekly ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma patients

Paul G. Richardson, Rachid Baz, Michael Wang, Andrzej J. Jakubowiak, Jacob P. Laubach, R. Donald Harvey, Moshe Talpaz, Deborah Berg, Guohui Liu, Jiang Yu, Neeraj Gupta, Alessandra Di Bacco, Ai-Min Hui, Sagar Lonial

Blood (2014) 124 (7): 1038–1046.

https://doi.org/10.1182/blood-2014-01-548826

Published: 2014

Includes: Supplemental data

Journal Articles

Phase 1 study of weekly dosing with the investigational oral proteasome inhibitor ixazomib in relapsed/refractory multiple myeloma

Shaji K. Kumar, William I. Bensinger, Todd M. Zimmerman, Craig B. Reeder, James R. Berenson, Deborah Berg, Ai-Min Hui, Neeraj Gupta, Alessandra Di Bacco, Jiang Yu, Yaping Shou, Ruben Niesvizky

Blood (2014) 124 (7): 1047–1055.

https://doi.org/10.1182/blood-2014-01-548941

Published: 2014

Includes: Supplemental data

Journal Articles

AL Amyloidosis: Development Of a Conceptual Model and a Symptom Diary

Emuella Flood, David Seldin, Ai-Min Hui, Deborah Berg, Huamao Mark Lin

Blood (2013) 122 (21): 5609.

https://doi.org/10.1182/blood.V122.21.5609.5609

Published: 2013

NARROW

TAK-981, a First-in-Class SUMO-Activating Enzyme Inhibitor, Combined with Rituximab in Adult Patients (Pts) with CD20-Positive Relapsed/Refractory (R/R) Non-Hodgkin Lymphoma (NHL): Phase 1 Data

Phase 1b/2 Study of the First-in-Class SUMO-Activating Enzyme Inhibitor TAK-981 in Combination with Monoclonal Antibodies in Patients with Triple-Class Refractory Multiple Myeloma

Mezagitamab Induces Immunomodulatory Effect in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

The Binding of CD38 Therapeutics to Red Blood Cells and Platelets Subverts Depletion of Target Cells

Primary Results from the Phase 3 Tourmaline-AL1 Trial of Ixazomib-Dexamethasone Versus Physician's Choice of Therapy in Patients (Pts) with Relapsed/Refractory Primary Systemic AL Amyloidosis (RRAL)

Preliminary Results from a Phase 1b Study of TAK-079, an Investigational Anti-CD38 Monoclonal Antibody (mAb) in Patients with Relapsed/ Refractory Multiple Myeloma (RRMM)

A Single Administration of the Cytolytic CD38 Antibody TAK-079 to Healthy Subjects: Tolerability, Pharmacokinetics and Pharmacodynamics

Addition of Ixazomib to an Rd Backbone Improves Clinical Benefit in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (Pts) with Non-Canonical NF-KB Activation — Results from the Tourmaline-MM1 Study

Overall Survival (OS) Benefit of Oral Ixazomib in Combination with Lenalidomide and Dexamethasone (IRd) Vs Lenalidomide and Dexamethasone (Rd) in Asian Patients (pts) with Relapsed and/or Refractory Multiple Myeloma (RRMM): Pooled-Analysis from the Tourmaline-MM1 and the China Continuation Studies

Ixazomib significantly prolongs progression-free survival in high-risk relapsed/refractory myeloma patients

Efficacy and Safety of Long-Term Ixazomib Maintenance Therapy in Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) Not Undergoing Transplant: An Integrated Analysis of Four Phase 1/2 Studies

A phase 1/2 study of the oral proteasome inhibitor ixazomib in relapsed or refractory AL amyloidosis

Higher c-MYC Expression Is Associated with Ixazomib-Lenalidomide-Dexamethasone (IRd) Progression-Free Survival (PFS) Benefit Versus Placebo-Rd: Biomarker Analysis of the Phase 3 Tourmaline-MM1 Study in Relapsed/Refractory Multiple Myeloma (RRMM)

Longer Time to Best Response and Depth of Response Are Associated with Improved Duration of Best Achieved Response and Progression-Free Survival (PFS): Post-Hoc Analysis of Phase 3 Tourmaline-MM1 Trial in Relapsed/Refractory Multiple Myeloma (RRMM)

Ixazomib, an Investigational Oral Proteasome Inhibitor (PI), in Combination with Lenalidomide and Dexamethasone (IRd), Significantly Extends Progression-Free Survival (PFS) for Patients (Pts) with Relapsed and/or Refractory Multiple Myeloma (RRMM): The Phase 3 Tourmaline-MM1 Study (NCT01564537)

Long-Term Outcome of a Phase 1 Study of the Investigational Oral Proteasome Inhibitor (PI) Ixazomib at the Recommended Phase 3 Dose (RP3D) in Patients (Pts) with Relapsed or Refractory Systemic Light-Chain (AL) Amyloidosis (RRAL)

Long-Term Ixazomib Maintenance Is Tolerable and Improves Depth of Response Following Ixazomib-Lenalidomide-Dexamethasone Induction in Patients (Pts) with Previously Untreated Multiple Myeloma (MM): Phase 2 Study Results

Phase 1 study of twice-weekly ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma patients

Phase 1 study of weekly dosing with the investigational oral proteasome inhibitor ixazomib in relapsed/refractory multiple myeloma

AL Amyloidosis: Development Of a Conceptual Model and a Symptom Diary

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American Society of Hematology

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