50th ASH Annual Meeting and Exposition (December 6 - 9, 2008): Myeloma - Therapy, Excluding Transplantation Poster I

Saturday, December 6, 2008: 5:30 PM-7:30 PM

Hall A (Moscone Center)

Phase I-II Trial of Oral Cyclophosphamide, Prednisone and Lenalidomide (Revlimid^®) (CPR) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma

Donna E. Reece, MD¹, Esther Masih-Khan¹^*, Arooj Khan¹^*, Peter Anglin, MD¹, Christine Chen, MD¹, Vishal Kukreti, MD²^*, Joseph R. Mikhael, MD³^* and Suzanne Trudel, MD¹^*

¹University Health Network, Princess Margaret Hospital, Toronto, ON, Canada
²Medical Oncology and Hematology, Princess Margaret Hospital, Toronto, ON, Canada
³Mayo Clinic Arizona, Scottsdale, AZ

1724

Treatment of Relapsed and Refractory Multiple Myeloma in Patients with p53 Deletion

Donna E. Reece, MD¹, Young Trieu, MSc²^*, Hong Chang, MD³^*, Wei Xu, PhD⁴^*, Peter Anglin, MD¹, Christine Chen, MD²^*, Vishal Kukreti, MD²^*, Suzanne Trudel, MD²^* and Joseph Mikhael, MD⁵

¹Medical Oncology and Hematology, Princess Margaret Hospital, Toronto, ON, Canada
²Princess Margaret Hospital, Toronto, ON, Canada
³Laboratory Hematology, University Health Network, Toronto, ON, Canada
⁴Biostatistics, Princess Margaret Hospital, Toronto, ON, Canada
⁵Division of Hematology, Mayo Clinic, Scottsdale Campus, Scottsdale, AZ

1725

Reversibility of Renal Impairment of Multiple Myeloma Patients Treated with Bortezomib-Based Regimens: Identification of Predictive Factors

Meletios A. Dimopoulos, Maria Roussou^*, Efstathios Kastritis^*, Maria Gavriatopoulou^*, Flora Zagouri^*, Magdalini Migkou^*, Charis Matsouka^*, Despina Barmparousi^*, Dimitrios Christoulas^*, Erasmia Psimenou^*, Irini Grapsa^* and Evangelos Terpos^*

Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece

1726

Treatment of Patients with Relapsed/Refractory Multiple Myeloma (MM) with Lenalidomide and Dexamethasone with or with Bortezomib Depending on Prior Neurotoxicity: Prospective Evaluation of the Impact of Cytogenetic Abnormalities and Assessment of Bone Met

Meletios A. Dimopoulos¹, Efstathios Kastritis¹^*, Dimitrios Christoulas¹^*, Magdalini Migkou¹^*, Maria Gavriatopoulou¹^*, Flora Zagouri¹^* and Evangelos Terpos²

¹Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece
²Department of Hematology & Medical Research, 251 General Air Force Hospital, Athens, Greece

1727

Bortezomib–Melphalan–Prednisone (VMP) in Newly Diagnosed Multiple Myeloma Patients with Impaired Renal Function: Cohort Analysis of the Phase III VISTA Study

Meletios A Dimopoulos¹, Paul Richardson², Rudolf Schlag³^*, Nuriet K Khuageva⁴^*, Ofer Shpilberg⁵^*, Efstathios Kastritis¹^*, Martin H Kropff⁶, Maria Teresa Petrucci⁷, Michel Delforge⁸, Julia A Alexeeva⁹^*, Rik Schots¹⁰^*, Tamas Masszi¹¹, Maria-Victoria Mateos¹²^*, William Deraedt¹³^*, Kevin Liu¹⁴^*, Andrew Cakana¹³, Helgi van de Velde¹³^* and Jesus F San Miguel¹⁵

¹Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece
²Dana-Farber Cancer Institute, Boston, MA
³Praxis for Hematology and Oncology, Wurzburg, Germany
⁴Hematology Department, SP Botkin Moscow City Clinical Hospital, Moscow, Russia
⁵Comprehensive Center of Thalassemia & Hemoglobinopathies, Institute of Hematology, Petah Tikva, Israel
⁶University of Munster, Munster, Germany
⁷Hematology, University La Sapienza, Rome, Italy
⁸Myeloma Study Group, Belgian Hematological Society, Leuven, Belgium
⁹Haematology Department, St Petersburg City Hospital, St Petersburg, Russia
¹⁰Myeloma Study Group, Belgian Hematological Society, Brussels, Belgium
¹¹St. Laszlo Hospital of Budapest, Budapest, Hungary
¹²Haematology, Hospital Universitario de Salamanca, Salamanca
¹³Johnson & Johnson Pharmaceuticals Research & Development, Beerse, Belgium
¹⁴Research and Development, Johnson & Johnson Pharmaceutical, Raritan, NJ
¹⁵Hospital Universitario Salamanca. CIC, IBMCC (USAL-CSIC), Salamanca, Spain

1728

The Administration of Bortezomib, Dexamethasone and Thalidomide (VTD) after ASCT in Myeloma Patients Who Do Not Receive Bisphosphonates Normalizes sRANKL, Dickkopf-1 and Improves Abnormal Osteoclast Function and Impaired Angiogenesis

Evangelos Terpos¹, Efstathios Kastritis²^*, Dimitrios Christoulas²^*, Magdalini Migkou²^*, Maria Gavriatopoulou²^* and Meletios A. Dimopoulos²

¹Department of Hematology & Medical Research, 251 General Air Force Hospital, Athens, Greece
²Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece

1729

Prognostic Impact of the Plasma Cell Labeling Index (LI) in Newly Diagnosed Myeloma Patients Treated with Thalidomide-Dexamethasone (Thal/Dex) or Lenalidomide-Dexamethasone (Len/Dex)

Prashant Kapoor, MD¹^*, Shaji Kumar, MD¹, Philip R Greipp, MD¹^*, Kristina M. Laumann¹^*, Sumithra Mandrekar, PhD²^*, S. Vincent Rajkumar, MD³^* and Thomas E. Witzig, MD⁴^*

¹Hematology, Mayo Clinic, Rochester, MN
²Division of Biostatistics, Mayo Clinic, Rochester, MN
³Hematology, College of Medicine, Mayo Clinic, Rochester, MN
⁴Mayo Clinic, Rochester, MN

1730

The Importance of Bone Marrow Examination in Determining Complete Response to Therapy in Patients with Multiple Myeloma

Cheng E Chee¹^*, Shaji Kumar¹, Dirk R Larson²^*, Robert A Kyle¹, Angela Dispenzieri¹, Morie A Gertz¹^*, Colin L Colby²^* and S. Vincent Rajkumar¹^*

¹Hematology, Mayo Clinic, Rochester, MN
²Statistics, Mayo Clinic, Rochester, MN

1731

The Impact of Cytogenetics on the Outcomes of Treatment with Lenalidomide Plus Dexamethasone in Relapsed or Refractory Multiple Myeloma

Nizar J Bahlis, MD¹, Kevin W. Song²^*, Tommy Fu³^*, Birgitte J Roland, MD, FCCMG, DABMG⁴^*, Hong Chang⁵^*, Doug Horsman, MD, PhD⁶^*, Adnan Mansoor, MD, FRCPC⁷, Christine Chen, MD⁸, Esther Masih-Khan⁸^*, Young Trieu, MSc⁸^*, Helene Bruyere, MD⁹, Douglas A. Stewart, MD, FRCPC¹⁰ and Donna E. Reece, MD¹¹

¹Department of Hematology, Medicine, University of Calgary, Calgary, AB, Canada
²Hematology, Leukemia/BMT Program of BC, Vancouver, BC, Canada
³Celgene Corporation, Summit, NJ
⁴Cancer Cytogenetics, Calgary Lab Services, University of Calgary, Calgary, AB, Canada
⁵Laboratory Hematology, University Health Network, Toronto, ON, Canada
⁶Department of Pathology and Laboratory Medicine, British Columbia Cancer Agency, Vancouver, BC, Canada
⁷University of Calgary, Calgary, AB, Canada
⁸Medical Oncology and Hematology, Princess Margaret Hospital, Toronto, ON, Canada
⁹Vancouver Hosp. & Health Ctr., Vancouver, BC, Canada
¹⁰Tom Baker Cancer Centre, Calgary, AB, Canada
¹¹Princess Margaret Hospital, Toronto, ON, Canada

1732

A Multicenter Phase I/II Dose Escalation Study of Lenalidomide in Combination with Melphalan and Dexamethasone in Subjects with Newly-Diagnosed Light-Chain (AL)-Amyloidosis

Philippe Moreau¹^*, Arnaud Jaccard²^*, Lotfi Benboubker, MD³^*, Bruno Royer⁴^*, Valerie Coiteux, MD⁵^*, Franck Bridoux⁶^*, Jean-Luc Harousseau⁷, Catherine Traulle⁸^*, Bernard Grosbois, MD, PhD⁹^*, Veronique Leblond¹⁰^*, May Alakl¹¹^*, Olivier Hermine¹²^* and Jean-Paul Fermand¹³

¹Service d'HÃÂ©matologie, CHU Hotel Dieu, Nantes, France, NAntes, France
²Department of Hematology, University Hospital, Limoges, France
³Service d'H�matologie et Th�rapie Cellulaire, CHU de Tours, Tours, France
⁴Service d'H�matologie, CHU H�pital Sud, Amiens, France
⁵Maladies du Sang, UAM Allo-CSH - EA2686, Lille, France
⁶Department of Nephrology, University Hospital, Poitiers, France
⁷H�pital H�tel Dieu, Nantes, France
⁸Department of Hematology, University Hospital, Lyon, France
⁹Internal Medicine Department, University Hospital, Rennes, France
¹⁰Department of Hematology, University Hospital Pitie-Salpetriere, Paris, France
¹¹Celgene France, Paris, France
¹²Hopital Necker, Paris, France
¹³Immuno-Hematology Unit, Saint-Louis Hospital, Paris, France

1733

Risk-Adapted Cyclophosphamide, Thalidomide and Dexamethasone (CTD) for the Treatment of Systemic AL Amyloidosis: Long Term Outcomes among 202 Patients

Simon DJ Gibbs^*, Prayman T Sattianayagam^*, Helen J Lachmann^*, Mark Offer^*, Julian D Gillmore^*, Philip N Hawkins^* and Ashutosh Wechalekar

University College London Medical School, National Amyloidosis Center, London, United Kingdom

1734

Phase I/II Study of Lenalidomide, Intermediate Dose Dexamethasone and Low Dose Cyclophosphamide (RDC) for the Treatment of Patients with Primary Systemic Amyloidosis (AL)

Efstathios Kastritis¹^*, Flora Zagouri¹^*, Maria Roussou¹^*, Magdalini Migkou¹^*, John Boletis²^*, Theofanis Apostolou³^* and Meletios A. Dimopoulos¹

¹Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece
²Department of Nephrology, Laiko Hospital, Athens, Greece
³Department of Nephrology, Evangelismos General Hospital, Athens, Greece

1735

Melphalan and Dexamethasone Is Less Effective for Patients with Immunoglobulin Light Chain Amyloidosis (AL) with High Bone Marrow Plasmacytosis

Nelson Leung, MD¹, Heidi D Gunderson, Pharm.D.²^*, Tow S Tan, MD, CM³, Angela Dispenzieri, MD³, Morie A Gertz, M.D.³^*, Steven R Zeldenrust, MD, PhD³, Martha Q Lacy, MD³^*, Francis K Buadi, MBChB³^*, Suzanne R. Hayman, MD³ and Shaji Kumar, MD³

¹Nephrology, Mayo Clinic, Rochester, Rochester, MN
²Pharmacology, Mayo Clinic, Rochester, Rochester, MN
³Hematology, Mayo Clinic Rochester, Rochester, MN

1736

Single Center Experience of Lenalidomide / Dexamethasone Treatment in 40 Patients with Light Chain Amyloidosis: High Toxicity in Patients with Severe Impaired Renal and Cardiac Function

Stefan O Schoenland¹^*, Tilmann Bochtler²^*, Sascha Dietrich²^*, Ulrike Klein²^*, Hartmut Goldschmidt²^*, Anthony Ho² and Ute Hegenbart²^*

¹Internal Medicine V, Hematology/Oncology, Amyloidosis Clinic, University Hospital, Heidelberg, Germany
²University Hospital

1737

Long Term Follow-up of Patients with Immunoglobulin Light Chain Amyloidosis Treated with Lenalidomide and Dexamethasone

Angela Dispenzieri¹^*, Martha Lacy, MD¹, Stephen R. Zeldenrust¹^*, Suzanne R. Hayman, MD¹, Shaji K. Kumar¹^*, John A. Lust, MD, PhD¹, Jake Allred²^*, S. Vincent Rajkumar¹^*, Philip R. Greipp, MD¹^*, Kristina Laumann¹^*, Stephen Russell¹^*, Francis Buadi¹^*, Thomas E Witzig¹^* and Morie A Gertz¹^*

¹Hematology, Mayo Clinic, Rochester, MN
²Division of Biostatistics, Mayo Clinic, Rochester, MN

1738

Primary Therapy with Bortezomib—the Role of Induction, Maintenance, and Re-Induction in Patients with High Risk Myeloma. Update of Results from E2A02

Angela Dispenzieri, MD¹, Susanna Jacobus, Ph.D.²^*, David H. Vesole, MD, PhD³, S. Vincent Rajkumar¹ and Philip R. Greipp, MD¹^*

¹Hematology, Mayo Clinic, Rochester, MN
²Biostatistics, Eastern Cooperative Oncology Group, Boston, MA
³St. Vincent's Comprehensive Cancer Center, New York, NY

1739

Post Autologous Transplantation Consolidation of Multiple Myeloma with Idiotype-Pulsed Antigen Presenting (Dendritic) Cells (APC8020) Is Associated with Prolonged Survival

Martha Q. Lacy, MD, Sumithra Mandrekar^*, Brian Kabat^*, Angela Dispenzieri^*, Suzanne Hayman^*, Shaji Kumar^*, Francis Buadi^*, David Dingli^*, Mark Litzow^*, Peter Wettstein^*, S. Vincent Rajkumar^*, Dennis Gastineau^* and Morie A. Gertz, MD^*

Mayo Clinic, Rochester, MN

1740

Effect of Venous Thrombotic Events on Overall Survival in Multiple Myeloma: Analysis of Thrombotic Events Occurring in E4A03A Randomized Trial of Lenalidomide Plus High-Dose Dexamethasone (RD) Versus Lenalidomide Plus Low-Dose Dexamethasone (Rd) in Newly Diagnosed Multiple Myeloma, a Trial Coordinated by the Eastern Cooperative Oncology Group (ECOG)

Susanna Jacobus¹^*, Shaji Kumar², Natalie Scott Callander³, Rafat Abonour⁴, Rafael Fonseca⁵^*, David Siegel⁶, Philip Greipp⁷^* and S.Vincent Rajkumar²^*

¹Biostatistics and Computational Biology, Dana Farber Cancer Institute, Boston, MA
²Mayo Clinic, Rochester, MN
³University of Wisconsin, Madison, WI
⁴Indiana University Cancer, Indianapolis, IN
⁵Hematology and oncology, Mayo Clinic Arizona, Scottsdale, AZ
⁶Hackensack University Medical Center, Hackensack, NJ
⁷Hematology, Mayo Clinic, Rochester, MN

1741

Erythropoiesis-Stimulating Agents Do Not Adversely Affect Long-Term Outcomes Nor Increase the Risk of Thromboembolic Events in Multiple Myeloma Patients Treated in the Phase III VISTA Trial

Paul Richardson¹, Rudolf Schlag²^*, Nuriet K Khuageva³^*, Meletios A. Dimopoulos⁴, Ofer Shpilberg⁵^*, Martin H Kropff⁶, Michel Delforge⁷, Maria Teresa Petrucci⁸, Victor A Rossiev⁹^*, Jian Hou¹⁰^*, Tadeusz Robak¹¹, Maria-Victoria Mateos¹²^*, Kenneth C. Anderson¹³, Andrew Cakana¹⁴, Kevin Liu¹⁵^*, William Deraedt¹⁴^*, Helgi van de Velde¹⁴^* and Jesus F. San Miguel¹⁶

¹Dana-Farber Cancer Institute, Boston, MA
²Praxis for Hematology and Oncology, Wurzburg, Germany
³Hematology Department, SP Botkin Moscow City Clinical Hospital, Moscow, Russia
⁴Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece
⁵Hematology, Rabin Medical Center, Petah-Tikva, Israel
⁶University of Munster, Munster, Germany
⁷Myeloma Study Group, Belgian Hematological Society, Brussels, Belgium
⁸University La Sapienza, Roma, Italy
⁹Haematology Department, Samara Region Clinical Hospital, Samara, Russia
¹⁰Hematology, Changzheng Hospital, Shanghai, China
¹¹Department of Hematology, Medical University of Lodz, Lodz, Poland
¹²University Hospital of Salamanca, Salamanca, Spain
¹³Medical Oncology, Dana-Farber Cancer Institute, Boston, MA
¹⁴Johnson & Johnson Pharmaceuticals Research & Development, Beerse, Belgium
¹⁵Johnson & Johnson Pharmaceutical, Research and Development, Raritan, NJ
¹⁶Hospital Universitario Salamanca. CIC, IBMCC (USAL-CSIC), Salamanca, Spain

1742

Lenalidomide, Bortezomib, and Dexamethasone in Patients with Relapsed or Relapsed/Refractory Multiple Myeloma (MM): Encouraging Response Rates and Tolerability with Correlation of Outcome and Adverse Cytogenetics in a Phase II Study

Paul Richardson, MD¹, Sundar Jagannath, MD², Andrzej Jakubowiak, MD, PhD³, Sagar Lonial, MD⁴, Noopur Raje, MD⁵^*, Melissa Alsina, MD⁶^*, Irene Ghobrial, MD¹, Amitabha Mazumder, MD², Nikhil C Munshi, MD¹, David H Vesole, MD, PhD², Kathleen Colson, RN, BSN, BS¹^*, Mary L McKenney¹^*, Laura Lunde, BA¹^*, Sarah Kennedy, BS²^*, Kara Kosakowski⁶^*, Constantine Mitsiades, MD, PhD¹^*, Teru Hideshima, MD, PhD¹^*, Robert D Knight, MD⁷, Dixie-Lee Esseltine, MD⁸ and Kenneth C Anderson, MD¹

¹Dana-Farber Cancer Institute, Boston, MA
²St. Vincent's Comprehensive Cancer Center, New York, NY
³University of Michigan Comprehensive Cancer Center, Ann Arbor, MI
⁴Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA
⁵Division of Hematology and Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA
⁶H. Lee Moffitt Cancer Center, Tampa, FL
⁷Celgene Inc., Summit, NJ
⁸Millennium Pharmaceuticals, The Takeda Oncology Company, Cambridge, MA

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^*signifies non-member of ASH

653.P1.73 Myeloma - Therapy, Excluding Transplantation Poster I