August 2015

Hematologic Malignancies Clinical Trials

Hematologic Malignancies And Stem Cell Transplant Newsletter

In this issue of our clinical trials newsletter, we wish to bring to your attention the expansion of clinical research in multiple myeloma at University Hospitals Seidman Cancer Center. As the therapeutic armamentarium in myeloma grows, our goal is to have studies available for patients in all disease stages, and to provide access to novel agents and therapeutic strategies.

We have recently opened two trials using the anti-myeloma monoclonal antibodies daratumumab and elotuzumab in combination with other therapies for previously untreated patients.

Two upcoming trials will evaluate the role of the oral proteasome inhibitor Ixazomib for previously untreated patients, both in the induction phase and as maintenance therapy.

For patients with relapsed disease, phase I trials available at UH Seidman Cancer Center are testing novel, rationally designed combinations of novel agents. We are also testing lenalidomide as an alternative for watchful waiting in patients with high – risk smoldering myeloma.

We also would like to welcome two additional colleagues to our Hematologic Malignancies Team:  Ehsan Malek, MD and Leland Metheny, MD will focus their practice in plasma cell disorders, strengthening our myeloma program.

Ehsan Malek, MD is a graduate of Shahid Beheshti University in Tehran, Iran. He completed his Internal Medicine Residency at the University of Utah, before moving on to University of Cincinnati, where he completed a Hematology and Oncology Fellowship as well as an Experimental Therapeutics Fellowship. His clinical focus will be plasma cell disorders. His research focus will be in experimental therapeutics in plasma cell disorders.

Leland Metheny, MD is a graduate from Case Western Reserve University. He completed his Internal Medicine, Hematology and Oncology training at University Hospitals Cleveland Medical Center. Dr. Metheny’s research has focused on stem cell transplant and he is currently investigating the use of intraosseous co-transplantation of umbilical cord blood and mesenchymal stem cells. His practice will center around plasma cell disorders, in particular with regards to stem cell therapies for this patient population. His research focus will be in novel approaches to stem cell transplant.

Please feel free to contact us regarding clinical studies in myeloma, other hematologic malignancies and stem cell transplant at the following links:

Marcos de Lima, MD
Paolo F. Caimi, MD

New Monoclonal Antibodies for Untreated Myeloma Patients:

JAN1A14: VMP +/- Daratumumab for untreated myeloma patients.
Eligible patients are those for whom high-dose therapy and autologous transplant is not an option. Daratumumab is a monoclonal antibody directed against CD38. It has demonstrated single agent activity in relapsed multiple myeloma. This randomized phase III trial is aimed at improving the outcomes of standard induction therapy.

For more information, contact Marcos de Lima, MD at Marcos.deLima@UHhospitals.org

S1211: Elotuzumab and Bortezomib, Dexamethasone and Lenalidomide for newly diagnosed high-risk myeloma patients.
Elotuzumab is a monoclonal antibody targeting CS1, a glycoprotein found exclusively in myeloma cells. It has been observed to have significant single agent clinical activity in relapsed myeloma. This trial is aimed at determining the safety of its combination with induction therapy with bortezomib, dexamethasone and lenalidomide.

For more information, contact Brenda W. Cooper, MD at Brenda.Cooper@UHhospitals.org

Novel Drug Combinations for Relapsed Multiple Myeloma

CASE4A13: Ixazomib (MLN9708) plus Panobinostat and Dexamethasone for relapsed myeloma
This phase I study is evaluating the safety of a combination of two novel agents: the oral proteasome inhibitor Ixazomib and the histone deacetylase Panobinostat.

For more information, contact Ehsan Malek, MD at Ehsan.Malek@UHhospitals.org

CASE1A09: Very low dose continuous azacytidine plus lenalidomide and dexamethasone for relapsed multiple myeloma.
This phase I/II trial is evaluating the safety and efficacy of a novel dosing schedule of azacytidine, in combination with lenalidomide

For more information, contact Hilliard M. Lazarus, MD at Hilliard.Lazarus2@UHhospitals.org

Immunomodulatory Therapy for Patients with Smoldering Myeloma

E3A06: Lenalidomide for patients with high-risk smoldering myeloma
The standard management strategy for smoldering myeloma is watchful waiting. This important multicenter study is evaluating the benefit of lenalidomide therapy for patients that have smoldering myeloma with high risk of progression to active disease.

For more information, contact Hilliard M. Lazarus, MD at Hilliard.Lazarus2@UHhospitals.org

UPCOMING STUDIES

MLNM2A13: Ixazomib, lenalidomide and dexamethasone for newly diagnosed multiple myeloma
This phase 3 randomized study will evaluate the efficacy of the oral proteasome Ixazomib combined with standard myeloma induction with lenalidomide and dexamethasone.

For more information, contact Marcos de Lima, MD at Marcos.deLima@UHhospitals.org

MLNM1A15: Ixazomib maintenance after induction therapy for patients ineligible for autologous transplantation
In patients ineligible for high dose therapy and autologous stem cell transplant, other strategies may provide progression free and overall survival benefit. This trial is evaluating the use of maintenance with the oral proteasome Ixazomib after initial induction therapy

Among the nation’s leading academic medical centers, University Hospitals Cleveland Medical Center is the primary affiliate of Case Western Reserve University School of Medicine, a nationally recognized leader in medical research and education.

U.S. News & World Report Best Hospitals 2013-2014 Honor Roll - CancerUS News Best Grad School Medical Research 2014

University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine are consistently recognized as two of the premier institutions in the nation, according to U.S. News & World Report’s annual rankings.

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Stanton Gerson

Stan Gerson, MD
Director, University Hospitals Seidman Cancer Center Director, Case Comprehensive Cancer Center Director, National Center for Regenerative Medicine

Neal Meropol

Neal Meropol, MD
Chief, Division of Hematology and Oncology Associate Director for Clinical Programs University Hospitals Seidman Cancer Center at UH Cleveland Medical Center Associate Director for Clinical Research Case Comprehensive Cancer Center

New Mobile App for Clinical Trials

UH Seidman Cancer Center has launched a clinical trials search website and mobile-device app developed especially for cancer patients. These new tools provide intuitive interfaces with easy-to-understand language for browsing more than 150 available cancer clinical trials offered in collaboration with the Case Comprehensive Cancer Center. To date, hundreds of patients have taken advantage of these new search capabilities, directing them to clinical trials where appropriate, or to a nurse who answers their questions.