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Journal Articles

Phase 1/1b Pharmacokinetic (PK) and Safety Study of the Investigational Oral Proteasome Inhibitor (PI) Ixazomib in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (Pts) with Severe Renal Impairment or End-Stage Renal Disease (ESRD) Requiring Hemodialysis

Neeraj Gupta, PhD, Michael J Hanley, PhD, R. Donald Harvey, PharmD, Ashraf Z Badros, MD, Brea C. Lipe, MD, Vishal Kukreti, Jesus G. Berdeja, MD, Huyuan Yang, PhD, Ai-Min Hui, MD PhD, Xiaoquan Zhang, MD PhD, Karthik Venkatakrishnan, PhD, Ajai Chari, MD

Blood (2015) 126 (23): 4227.

https://doi.org/10.1182/blood.V126.23.4227.4227

Published: 2015

Journal Articles

MM-008: A Phase 1 Trial Evaluating Pharmacokinetics and Tolerability of Pomalidomide + Low-Dose Dexamethasone in Patients with Relapsed or Refractory and Refractory Multiple Myeloma and Renal Impairment

Jeffrey Matous, MD, David S Siegel, MD PhD, Sagar Lonial, MD, R. Donald Harvey, PharmD, Claudia Kasserra, PhD, Yan Li, PhD, Min Chen, PhD, Thomas Doerr, MSc, Lars Sternas, MD, Mohamed H. Zaki, MD, Christian Jacques, MD, Jatin J. Shah, MD

Blood (2014) 124 (21): 4730.

https://doi.org/10.1182/blood.V124.21.4730.4730

Published: 2014

Journal Articles

Phase I Study of the Combination of Carfilzomib and Panobinostat for Patients with Relapsed and Refractory Myeloma: A Multiple Myeloma Research Consortium (MMRC) Clinical Trial

Jonathan L. Kaufman, MD, Todd Zimmerman, MD, Cara A Rosenbaum, MD, Ajay K. Nooka, MD MPH, Leonard T Heffner, MD, R. Donald Harvey, PharmD, Charise Gleason, MSN, ANP-BC, AOCNP, Colleen Lewis, MSN, ANP-BC, AOCNP, Cathy Sharp, RN, MN, OCN, Kenisha W Barron, B.S, CCRC, Sagar Lonial, MD

Blood (2014) 124 (21): 32.

https://doi.org/10.1182/blood.V124.21.32.32

Published: 2014

Journal Articles

Real-World Practice Patterns with Carfilzomib in Patients with Relapsed and Refractory Multiple Myeloma

R. Donald Harvey, PharmD, Ze Cong, PhD, Winifred Werther, PhD, Jan L. Lethen, MS, Sagar Lonial, MD

Blood (2014) 124 (21): 5765.

https://doi.org/10.1182/blood.V124.21.5765.5765

Published: 2014

Journal Articles

The Budget Impact of Orphan Drugs in the U.S.: A 2007-2013 MIDAS Sales Data Analysis

Victoria Divino, Mitch Dekoven, MHSA, Weiying Wang, MPH, Michael Kleinrock, MA, R. Donald Harvey, PharmD, Rolin L Wade, RPh, MS, Satyin Kaura, MSci, MBA

Blood (2014) 124 (21): 736.

https://doi.org/10.1182/blood.V124.21.736.736

Published: 2014

Journal Articles

Predictors Of Survival Outcomes In Phase I Relapsed Or Refractory Multiple Myeloma Patients

R. Donald Harvey, PharmD, Meagan S. Barbee, PharmD, Ajay K. Nooka, MD, MPH, Sungjin Kim, MS, Zhengjia Chen, PhD, Leonard T. Heffner, MD, Jonathan L. Kaufman, MD, Sagar Lonial, M.D.

Blood (2013) 122 (21): 1958.

https://doi.org/10.1182/blood.V122.21.1958.1958

Published: 2013

Journal Articles

Lenalidomide, Bortezomib, and Dexamethasone (RVD) in Combination with Vorinostat As Front-Line Therapy for Patients with Multiple Myeloma (MM): Results of a Phase 1 Study

Jonathan L. Kaufman, MD, Jatin J. Shah, M.D., Jacob P. Laubach, MD, Alaina R. Mitchell, BS, Cathy Sharp, R.N., Colleen Lewis, MSN, ANP-BC, AOCNP, R. Donald Harvey, PharmD, Charise Gleason, MSN, ANP-BC, AOCNP, Daniela Casbourne, FNP-BC, AOCNP, Ajay K. Nooka, MD, MPH, FACP, Leonard T Heffner, MD, Paul G. Richardson, MD, Robert Z. Orlowski, M.D., Ph.D., Sagar Lonial, MD

Blood (2012) 120 (21): 336.

https://doi.org/10.1182/blood.V120.21.336.336

Published: 2012

Journal Articles

The Novel KSP Inhibitor ARRY-520 Is Active Both with and without Low-Dose Dexamethasone in Patients with Multiple Myeloma Refractory to Bortezomib and Lenalidomide: Results From a Phase 2 Study

Jatin J. Shah, M.D., Jeffrey A. Zonder, MD, Adam Cohen, MD, William Bensinger, MD, Jonathan L. Kaufman, MD, Robert Z. Orlowski, M.D., Ph.D., R. Donald Harvey, PharmD, Muneer H. Abidi, MD, Sheeba K. Thomas, MD, Duncan Walker, PhD, Brandi Hilder, Ann Marie Ptaszynski, MD, Sagar Lonial, MD

Blood (2012) 120 (21): 449.

https://doi.org/10.1182/blood.V120.21.449.449

Published: 2012

Journal Articles

A First-in-Disease Trial of in Vivo Costimulation Blockade for Acute GvHD Prevention: The Addition of Abatacept to Standard GvHD Prophylaxis Controls Early CD4+ T Cell Proliferation and Is Associated with Low Rates of Severe Acute GvHD

Divya Tiwari, MD, John Horan, Amelia Langston, MD, Muna Qayed, M.D., M.Sc., Jennifer Carr, Heather Renfroe, Couture Cynthia, Hanna J. Khoury, MD, Robertson Jennifer, R. Donald Harvey, PharmD, Aneesh Mehta, Edmund K. Waller, MD, PhD, Leslie S. Kean, MD, PhD

Blood (2012) 120 (21): 741.

https://doi.org/10.1182/blood.V120.21.741.741

Published: 2012

Journal Articles

A Predictive Model of Overall Survival (OS) for Patients with Relapsed/Refractory Multiple Myeloma (MM) Enrolling in Phase I Clinical Trials,

Ajay K. Nooka, MD, MPH, FACP, Samatha Muppidi, MD, R. Donald Harvey, PharmD, Jonathan L. Kaufman, MD, Amelia Langston, MD, Colleen Lewis, MSN, Lawrence H. Boise, PhD, Christopher R Flowers, MD, Sagar Lonial, MD

Blood (2011) 118 (21): 3954.

https://doi.org/10.1182/blood.V118.21.3954.3954

Published: 2011

Journal Articles

Renal Function Measures Improve on Lenalidomide and Dexamethasone and Compete with Patient Characteristics to Predict Lenalidomide Dose Density and Hematologic Toxicity: An E4A03 Analysis

R. Donald Harvey, PharmD, Susanna Joan Jacobus, MSc, S. Vincent Rajkumar, MD, Philip R. Greipp, MD, Sagar Lonial, MD

Blood (2011) 118 (21): 1882.

https://doi.org/10.1182/blood.V118.21.1882.1882

Published: 2011

Journal Articles

The Novel KSP Inhibitor ARRY-520 Demonstrates Single-Agent Activity in Refractory Myeloma: Results From a Phase 2 Trial in Patients with Relapsed/Refractory Multiple Myeloma (MM)

Sagar Lonial, MD, Adam Cohen, Jeffrey Zonder, MD, William I Benzinger, MD, Jonathan L. Kaufman, MD, Robert Z. Orlowski, MD, PhD, R. Donald Harvey, PharmD, Raymond Alexanian, M.D., Sheeba K Thomas, M.D., Donna Weber, MD, Duncan Walker, PhD, Brandi Hilder, PhD, Ann Ptaszynski, Jatin J Shah, MD

Blood (2011) 118 (21): 2935.

https://doi.org/10.1182/blood.V118.21.2935.2935

Published: 2011

Journal Articles

ARRY-520 Shows Durable Responses in Patients with Relapsed/Refractory Multiple Myeloma in a Phase 1 Dose-Escalation Study

Jatin J Shah, MD, Jeffrey Zonder, MD, Adam Cohen, Robert Z. Orlowski, MD, PhD, Raymond Alexanian, M.D., Sheeba K Thomas, M.D., Donna Weber, MD, Jonathan L. Kaufman, MD, R. Donald Harvey, PharmD, Duncan Walker, PhD, Kevin Litwiler, PhD, Sharon Karan, Brandi Hilder, Ann Marie Ptaszynski, MD, Sagar Lonial, MD

Blood (2011) 118 (21): 1860.

https://doi.org/10.1182/blood.V118.21.1860.1860

Published: 2011

Journal Articles

Temporal Changes in Plerixafor Administration Do Not Impact Hematopoietic Stem Cell Mobilization Efficacy: Results of a Prospective Clinical Trial

R. Donald Harvey, PharmD, Sagar Lonial, MD, Heather Renfroe, Rajni Sinha, MD, MRCP, Christopher R Flowers, MD, Mary Jo Lechowicz, MD, H. Jean Khoury, MD, FACP, Amelia Langston, MD, Edmund K Waller, MD PhD, Jonathan L. Kaufman, MD

Blood (2011) 118 (21): 2988.

https://doi.org/10.1182/blood.V118.21.2988.2988

Published: 2011

Journal Articles

Phase 1 Dose-Escalation Study of Multiple Dosing Schedules of the Investigational Drug MLN4924, a Nedd8-Activating Enzyme Inhibitor, In Patients with Relapsed and/or Refractory Multiple Myeloma or Lymphoma.

Jatin J Shah, MD, R. Donald Harvey, PharmD, Owen A O'Connor, MD, PhD, Andrzej J Jakubowiak, MD, PhD, Mitchell R Smith, MD, PhD, Robert Z. Orlowski, MD, PhD, George J Mulligan, PhD, Peter G Smith, PhD, Michael D Pickard, MA, Bruce J. Dezube, MD, Sagar Lonial, MD

Blood (2010) 116 (21): 2801.

https://doi.org/10.1182/blood.V116.21.2801.2801

Published: 2010

Journal Articles

Lenalidomide, Bortezomib, and Dexamethasone (RVD) In Combination with Vorinostat as Front-Line Therapy for Patients with Multiple Myeloma (MM): Initial Results of a Phase 1 Study

Jonathan L. Kaufman, MD, Jatin J Shah, MD, Jacob P. Laubach, MD, Leonard Heffner, MD, Dixil Francis, R. Donald Harvey, PharmD, Colleen Lewis, Mourad Tighiouart, Paul Richardson, Robert Z. Orlowski, MD, PhD, Sagar Lonial, MD

Blood (2010) 116 (21): 3034.

https://doi.org/10.1182/blood.V116.21.3034.3034

Published: 2010

Journal Articles

A Randomized Clinical Trial Comparing Cytokine Administration Sites for Mobilization of Peripheral Hematopoietic Progenitor Cells for Patients with Hematological Malignancies Undergoing Autologous Stem Cell Transplantation.

Heather Renfroe, Edmund K. Waller, MD, PhD, Mike Arnold, Louette Vaughn, R. Donald Harvey, PharmD, Ellie Hamilton, Sagar Lonial, MD, H. Jean Khoury, MD, Jonathan L. Kaufman, MD, Mary Jo Lechowicz, MD

Blood (2009) 114 (22): 4230.

https://doi.org/10.1182/blood.V114.22.4230.4230

Published: 2009

Journal Articles

A Phase I Clinical Trial Testing the Combination of Bortezomib and Tipifarnib in Relapsed/Refractory Multiple Myeloma.

Sagar Lonial, MD, Dixil Francis, MPH, Chatchada Karanes, Suzanne Trudel, MD, Akari M. Dollard, Fermin Aceo, Engin Gul, Sumeet Kakar, Amrita Y. Krishnan, MD, FACP, Donna E. Reece, MD, R. Donald Harvey, PharmD, Jonathan L. Kaufman, MD

Blood (2009) 114 (22): 3851.

https://doi.org/10.1182/blood.V114.22.3851.3851

Published: 2009

NARROW

Phase 1/1b Pharmacokinetic (PK) and Safety Study of the Investigational Oral Proteasome Inhibitor (PI) Ixazomib in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (Pts) with Severe Renal Impairment or End-Stage Renal Disease (ESRD) Requiring Hemodialysis

MM-008: A Phase 1 Trial Evaluating Pharmacokinetics and Tolerability of Pomalidomide + Low-Dose Dexamethasone in Patients with Relapsed or Refractory and Refractory Multiple Myeloma and Renal Impairment

Phase I Study of the Combination of Carfilzomib and Panobinostat for Patients with Relapsed and Refractory Myeloma: A Multiple Myeloma Research Consortium (MMRC) Clinical Trial

Real-World Practice Patterns with Carfilzomib in Patients with Relapsed and Refractory Multiple Myeloma

The Budget Impact of Orphan Drugs in the U.S.: A 2007-2013 MIDAS Sales Data Analysis

Predictors Of Survival Outcomes In Phase I Relapsed Or Refractory Multiple Myeloma Patients

Lenalidomide, Bortezomib, and Dexamethasone (RVD) in Combination with Vorinostat As Front-Line Therapy for Patients with Multiple Myeloma (MM): Results of a Phase 1 Study

The Novel KSP Inhibitor ARRY-520 Is Active Both with and without Low-Dose Dexamethasone in Patients with Multiple Myeloma Refractory to Bortezomib and Lenalidomide: Results From a Phase 2 Study

A First-in-Disease Trial of in Vivo Costimulation Blockade for Acute GvHD Prevention: The Addition of Abatacept to Standard GvHD Prophylaxis Controls Early CD4+ T Cell Proliferation and Is Associated with Low Rates of Severe Acute GvHD

A Predictive Model of Overall Survival (OS) for Patients with Relapsed/Refractory Multiple Myeloma (MM) Enrolling in Phase I Clinical Trials,

Renal Function Measures Improve on Lenalidomide and Dexamethasone and Compete with Patient Characteristics to Predict Lenalidomide Dose Density and Hematologic Toxicity: An E4A03 Analysis

The Novel KSP Inhibitor ARRY-520 Demonstrates Single-Agent Activity in Refractory Myeloma: Results From a Phase 2 Trial in Patients with Relapsed/Refractory Multiple Myeloma (MM)

ARRY-520 Shows Durable Responses in Patients with Relapsed/Refractory Multiple Myeloma in a Phase 1 Dose-Escalation Study

Temporal Changes in Plerixafor Administration Do Not Impact Hematopoietic Stem Cell Mobilization Efficacy: Results of a Prospective Clinical Trial

Phase 1 Dose-Escalation Study of Multiple Dosing Schedules of the Investigational Drug MLN4924, a Nedd8-Activating Enzyme Inhibitor, In Patients with Relapsed and/or Refractory Multiple Myeloma or Lymphoma.

Lenalidomide, Bortezomib, and Dexamethasone (RVD) In Combination with Vorinostat as Front-Line Therapy for Patients with Multiple Myeloma (MM): Initial Results of a Phase 1 Study

A Randomized Clinical Trial Comparing Cytokine Administration Sites for Mobilization of Peripheral Hematopoietic Progenitor Cells for Patients with Hematological Malignancies Undergoing Autologous Stem Cell Transplantation.

A Phase I Clinical Trial Testing the Combination of Bortezomib and Tipifarnib in Relapsed/Refractory Multiple Myeloma.

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American Society of Hematology

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American Society of Hematology

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