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Dr. Bruno - An Update of a Comparison of Nonmyeloablative Allografting with Autografting for Newly Diagnosed Myeloma
Benedetto Bruno, MD, PhD
San Giovanni Battista Hospital
University of Torino
Torino, Italy
12.17.07

"This was a genetically randomized study; in other words, all the patients newly diagnosed with multiple myeloma were HLA typed with their siblings."
Dr. Benedetto Bruno


To view the video full screen, click on the small button next to the volume control in the lower right hand corner.

[482] An Update of a Comparison of Nonmyeloablative Allografting with Autografting for Newly Diagnosed Myeloma. Session Type: Oral Session

B. Bruno, R. Sorasio, F. Patriarca, N. Mordini, B. Allione, F. Carnevale-Schianca, L. Giaccone, M. Rotta, P. Omedè, I. Baldi, S. Bringhen, M. Massaia, M. Aglietta, A. Levis, D. Mattei, R. Fanin, A. Palumbo, R. Storb, G. Ciccone, Mario Boccadoro University of Torino, Divisione di Ematologia, Torino, Italy; Universit di Udine; Cuneo; Alessandria; IRCC, Candiolo; FHCRC, Seattle

The concept of genetic randomisation has been applied to assess clinical outcomes between patients with hematological cancers treated with allografting or other therapies. Though not universally accepted, the comparison by the intention-to-treat principle between patients with HLA-identical siblings, who can be assigned to allografting, and those without, who cannot receive an allograft, is used as a surrogate for an unbiased randomisation. We previously published the results of a study where the treatment assignment of 162 newly diagnosed patients younger than 65 years was based only on the presence/absence of an HLA-identical sibling (Bruno et al, N Engl J Med). First-line treatment plans included a cytoreductive autograft followed by a nonmyeloablative allograft (Tandem auto-allo) or a second melphalan-based autograft (Double-auto). Primary endpoints were overall (OS) and event-free (EFS) survivals by intention-to-treat analysis. The 80 patients with a sibling donor were offered a Tandem auto-allo and the 82 without a Double-auto after high (140-200 mg/m2) or intermediate dose melphalan (100 mg/m2). After a median follow up of 45 (range 21-90) months, OS and EFS were significantly longer in patients with donors: 80 versus 54 months (p=0.01) and 35 versus 29 months (p=0.02). Median OS was not reached in the 58 (out of 60 enrolled, 97%) patients who completed Tandem auto-allo and was 58 months in the 46 (out of 59 enrolled, 78%) who completed high-dose double-auto (p=0.03). Here, we report a update analysis. At a median follow up of 56 months, OS was not reached for the 80 patients with an HLA-identical sibling and was 56 months for those without (HR 0.53, CI 95% 0.33-0.86, p=0.009). EFS remained significantly longer in patients with HLA-identical siblings: 35 versus 29 months (HR: 0.61; 95% Cl: 0.42-0.88, p=0.008). Median OS was not reached in the 58 patients who completed Tandem auto-allo and was 63 months in the 46 who completed high-dose double-auto (HR 0.47, CI 95% 0.25-0.86, p=0.016). EFS was 43 and 33 months (HR 0.64, CI 95% 0.40-1.02, p=0.06). By multivariate analysis, the presence of HLA-identical siblings was significantly correlated with longer OS and EFS. We carried out a stratified analysis, on the intent-to-treat population, that defined a patient subgroup at high risk in the light of high b -2-microglobulin levels or presence of del(13). The adjusted HRs by Cox models were 0.34 for OS and 0.52 for EFS similar to those obtained in the whole series. Though this exploratory analysis has low statistical power, its results indicate that del(13) does not offset the advantage in OS and EFS for patients with an HLA-identical sibling, but do not exclude an impact of del(13) in those patients undergoing an allograft. Attal et al. (N Engl J Med) previously reported median OS and EFS of 58 and 30 months, respectively, after double autologous transplantation, consistent with our results (OS: 63 months; EFS: 33 months). However, the EFS after Tandem auto-allo also indicates that long-term disease control is an issue. Allografting and new drugs with molecular targets should not be viewed as mutually exclusive. Thus, it is imperative to thoroughly explore their roles in increasing the response rates and their duration in Tandem auto-allo.

Abstract #482 appears in Blood, Volume 110, issue 11, November 16, 2007

Keywords: Multiple Myeloma|Allogeneic Hematopoietic Stem Cell Transplant|Autologous Hematopoietic Stem Cell Transplantation

Disclosure: No relevant conflicts of interest to declare.

Monday, December 10, 2007 1:45 PM

Session Info: Simultaneous Session: Clinical Results: Allogeneic Matched Related Donor Transplantation II (1:30 p.m.-3:00 p.m.)


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Elijah Alexander: ASH 2007: A Patient's Perspective
ASH 2007 INTERNATIONAL WEBCASTS
Dr. San Miguel - A Phase 3 Study Comparing BortezomibMelphalanPrednisone (VMP) with MelphalanPrednisone (MP) in Newly Diagnosed Multiple Myeloma.
Dr. Rajkumar - A Randomized Trial of Lenalidomide Plus High-Dose Dexamethasone (RD) Versus Lenalidomide Plus Low-Dose Dexamethasone (Rd) in Newly Diagnosed Multiple Myeloma (E4A03): A Trial Coordinated by the Eastern Cooperative Oncology Group
Dr. Richardson - Lenalidomide, Bortezomib, and Dexamethasone (Rev/Vel/Dex) as Front-Line Therapy for Patients with Multiple Myeloma (MM): Preliminary Resultsof a Phase 1/2 Study.
Dr. Kumar - Phase II Trial of Lenalidomide, Cyclophosphamide, and Dexamethasone (CRd) for Newly Diagnosed Myeloma
Dr. Palumbo - Bortezomib, Pegylated-Lyposomal-Doxorubicin and Dexamethasone Followed by Melphalan 100 mg/m in Elderly Newly Diagnosed Patients: An Interim Analysis
Dr. Palumbo - A Prospective, Randomized, Phase III Study of Enoxaparin Versus Aspirin Versus Low-Fixed-Dose of Warfarin in Newly Diagnosed Myeloma Patients Treated with Thalidomide-Containing Regimens
Dr. Jagannath - A Phase II Study of Bortezomib (Velcade®), Cylophosphamide (Cytoxan®), Thalidomide (Thalomid®) and Dexamethasone as First-Line Therapy for Multiple Myeloma
Dr. Reeder - Phase II Trial of Myeloma Induction Therapy with Cyclophosphamide, Bortezomib, and Dexamethasone (Cybor-D): Improved Response over Historical Lenalidomide-Dexamethasone Controls
Dr. Ludwig - Thalidomide-Dexamethasone vs. Melphalan-Prednisone as First Line Treatment in Elderly Patients with Multiple Myeloma
Dr. Zonder - Superiority of Lenalidomide (Len) Plus High-Dose Dexamethasone (HD) Compared to HD Alone as Treatment of Newly-Diagnosed Multiple Myeloma (NDMM): Results of the Randomized, Double-Blinded, Placebo-Controlled SWOG Trial S0232
Dr. Waage - Melphalan-Prednisone-Thalidomide to Newly Diagnosed Patients with Multiple Myeloma: A Placebo Controlled Randomised Phase 3 Trial
Dr. San Miguel - Dexamethasone Dose Adjustments Seem To Result in Better Efficacy and Improved Tolerability in Patients with Relapsed/Refractory Multiple Myeloma Who Are Treated with Lenalidomide/Dexamethasone (MM009/010 Sub-Analysis)
Dr. Jagannath - Updated Survival Analyses after Prolonged Follow-Up of the Phase 2, Multicenter CREST Study of Bortezomib in Relapsed or Refractory Multiple Myeloma
Dr. Bladé - The Prolonged Time to Progression with Pegylated Liposomal Doxorubicin + Bortezomib Versus Bortezomib Alone in Relapsed or Refractory Multiple Myeloma Is Unaffected by Extent of Prior Therapy or Previous Anthracycline Exposure
Dr. Davies - The Combination of Velcade, Idarubicin and Melphalan (VIM) Demonstrates Significant Clinical Activity in Relapsed/Refractory Myeloma Patients
Dr. Orlowski: Early Normalization of Serum Free Light Chain Is Associated with Prolonged Time to Progression Following Bortezomib Pegylated Liposomal Doxorubicin Treatment of Relapsed/Refractory Multiple Myeloma
Dr. Jakubowiak - A Multiple Myeloma Research Consortium (MMRC) Multicenter Phase I Trial of Perifosine (KRX-0401) in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (MM): Updated Results
Dr. Richardson - Tanespimycin (T) + Bortezomib (BZ) in Multiple Myeloma (MM): Confirmation of the Recommended Dose Using a Novel Formulation
Dr. Orlowski - Safety and Antitumor Efficacy of the Proteasome Inhibitor Carfilzomib (PR-171) Dosed for Five Consecutive Days in Hematologic Malignancies: Phase 1 Results
Dr. Ocio - Antimyeloma Efficacy of Plitidepsin (Aplidin): From Bench to the Bedside
Dr. Richardson - An Overview of Studies of the New Agent Perifosine (KRX-0401) Alone and in Combination for Patients with Relapsed/Refractory Multiple Myeloma
Dr. Richardson - Final Results of a Phase I Trial of Oral Vorinostat (Suberoylanilide Hydroxamic Acid, SAHA) in Patients with Advanced Multiple Myeloma
Dr. Ocio - Triple Combinations of the HDAC Inhibitor Panobinostat (LBH589) + Dexamethasone with Either Lenalidomide or Bortezomib Are Highly Effective in a Multiple Myeloma Mouse Model
Dr. Dispenzieri - Pre-Clinical Data and Preliminary Patient Results of Intravenous MV-NIS To Treat Relapsed, Refractory Multiple Myeloma
Dr. Davies - Aminopeptidase Inhibition as a Targeted Treatment Strategy in Myeloma
Dr. Zonder - Phase I Trial of HuLuc63 in Multiple Myeloma
Dr. Aggarwal: Curcumin downregulates NF-kB and related genes in patients with multiple myeloma: Results of a phase 1/2 study
Dr. Harousseau - VELCADE/Dexamethasone (Vel/D) Versus VAD as Induction Treatment Prior to Autologous Stem Cell Transplantion (ASCT) in Newly Diagnosed Multiple Myeloma (MM): Updated Results of the IFM 2005/01 Trial
Dr. Bruno - An Update of a Comparison of Nonmyeloablative Allografting with Autografting for Newly Diagnosed Myeloma
Dr. Hajek - Consolidation Therapy Based on Conventional Chemotherapy and Corticoids Do Not Provide Therapeutic Advantage for Newly Diagnosed Patients after Autologous Transplantation
Dr. Tosi - Superiority of Double over Single Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma and Prognostic Impact of Complete Response: Final Analysis of Bologna 96 Study
Dr. Beksac - Amplitude of Response, Early Mobilization (M) and Pre-Autologous Transplant (ASCT) Use of Bortezomib (V) and/or Thalidomide(T) Are Predictors of Longer Progression Free (PFS) and/or Overall Survival (OS) in Myeloma
Dr. Ladetto - Consolidation with Bortezomib, Thalidomide and Dexamethasone Induces Molecular Remissions in Autografted Multiple Myeloma Patients
Dr. Tosi - Bortezomib (Velcade)-Thalidomide-Dexamethasone (VTD) vs Thalidomide-Dexamethasone (TD) in Preparation for Autologous Stem-Cell (SC) Transplantation (ASCT) in Newly Diagnosed Multiple Myeloma
Dr. De la Rubia - Toxicity and Early Response after Single Daily Dose of Intravenous Busulfan and Melphalan as Conditioning Regimen for Autologous Stem Cell Transplantation in Patients with Multiple Myeloma. Session Type: Publication Only
Dr. Bladé - Tandem Autologous Transplant Versus Reduced Intensity Conditioned Allogeneic Transplant (Allo-RIC) as Second Intensification in Chemosensitive Patients with Multiple Myeloma (MM) Not Achieving Complete Remission (CR) or Near-CR with a First Autologous Transplant. Results from a Spanish PETHEMA/GEM Study.
Dr. Einsele - An Overview of Two Studies Conducted at the University Clinic of Würzburg
Dr. Liebisch - Prognostic Impact of Chromosomal Abnormalities in Elderly Patients with Multiple Myeloma Treated with High-Dose Melphalan (MEL140) and Autologous Stem Cell Transplantation
Dr. Avet-Loiseau - High-Resolution Genomic Profiles Identify Novel Genes and/or Chromosomal Regions with Prognostic and Oncogenic Significance in Myeloma Patients
Dr. Sezer - The Bone Resorption Marker Serum-ICTP and the Circulating Proteasome Levels Separate ISS-Stages 1-3 and Are the Most Powerful Prognostic Factors for Overall Survival in Newly Diagnosed Symptomatic Multiple Myeloma
Dr. Durie - Genetic Polymorphisms Identify the Likelihood of Bone Disease in Myeloma: Correlations with Myeloma Cell DKK1 Expression and High Risk Gene Signatures.
Dr. Kyle - Monoclonal Gammopathy of Undetermined Significance: Estimated Incidence and Duration Prior to Recognition
Dr. Kumar - Improving Survival in Multiple Myeloma: Impact of Novel Therapies
Dr. Jakubowiak - Targeted Therapy Against Clonogenic Myeloma Cells with Iodine I-131 Tositumomab (Bexxar™).
Dr. Kyle - Prognostic Value of the Serum Free Light Chain Ratio in Patients with Newly Diagnosed Myeloma: Proposed Incorporation into the International Staging System.
Dr. Goldschmidt - Angiogenic Signature of Multiple Myeloma Determined by Gene Expression Profiling


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ASH Overview
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ASH 2007 INTERNATIONAL WEBCASTS
We are pleased to be able to present overviews of ASH 2007 in French, Spanish, German, Italian, Turkish, and Czech.

Newly Diagnosed Myeloma
Dr. San Miguel - A Phase 3 Study Comparing BortezomibMelphalanPrednisone (VMP) with MelphalanPrednisone (MP) in Newly Diagnosed Multiple Myeloma.
Dr. Jesús San Miguel
Hospital Clinico Universitario
Universidad de Salamanca
Salamanca, Spain
Member, IMF Board of Scientific Advisors

Dr. Rajkumar - A Randomized Trial of Lenalidomide Plus High-Dose Dexamethasone (RD) Versus Lenalidomide Plus Low-Dose Dexamethasone (Rd) in Newly Diagnosed Multiple Myeloma (E4A03): A Trial Coordinated by the Eastern Cooperative Oncology Group
S. Vincent Rajkumar, MD
Mayo Clinic
Rochester, Minnesota
Member, IMF Board of Scientific Advisors

Dr. Richardson - Lenalidomide, Bortezomib, and Dexamethasone (Rev/Vel/Dex) as Front-Line Therapy for Patients with Multiple Myeloma (MM): Preliminary Resultsof a Phase 1/2 Study.
Paul Richardson, MD
Jerome Lipper Myeloma Center
Dana Farber Cancer Institute
Boston, MA
Member, IMF Board of Scientific Advisors

Dr. Kumar - Phase II Trial of Lenalidomide, Cyclophosphamide, and Dexamethasone (CRd) for Newly Diagnosed Myeloma
Shaji Kumar, MD
Mayo Clinic
Rochester, MN

Dr. Palumbo - Bortezomib, Pegylated-Lyposomal-Doxorubicin and Dexamethasone Followed by Melphalan 100 mg/m in Elderly Newly Diagnosed Patients: An Interim Analysis
Antonio Palumbo, MD
Ospedale Molinette
Torino, Italy
Member,IMF Board of Scientific Advisors

Dr. Palumbo - A Prospective, Randomized, Phase III Study of Enoxaparin Versus Aspirin Versus Low-Fixed-Dose of Warfarin in Newly Diagnosed Myeloma Patients Treated with Thalidomide-Containing Regimens
Antonio Palumbo, MD
Ospedale Molinette
Torino, Italy
Member,IMF Board of Scientific Advisors

Dr. Jagannath - A Phase II Study of Bortezomib (Velcade®), Cylophosphamide (Cytoxan®), Thalidomide (Thalomid®) and Dexamethasone as First-Line Therapy for Multiple Myeloma
Sundar Jagannath, MD
St. Vincent's Comprehensive Cancer Center
New York, New York
Member, IMF Board of Scientific Advisors

Dr. Reeder - Phase II Trial of Myeloma Induction Therapy with Cyclophosphamide, Bortezomib, and Dexamethasone (Cybor-D): Improved Response over Historical Lenalidomide-Dexamethasone Controls
Craig B. Reeder, MD
Mayo Clinic
Scottsdale, Arizona

Dr. Ludwig - Thalidomide-Dexamethasone vs. Melphalan-Prednisone as First Line Treatment in Elderly Patients with Multiple Myeloma
Heinz Ludwig, MD
Wilhelminenspital der Stadt Wein
Vienna, Austria
Member, IMF Board of Scientific Advisors

Dr. Zonder - Superiority of Lenalidomide (Len) Plus High-Dose Dexamethasone (HD) Compared to HD Alone as Treatment of Newly-Diagnosed Multiple Myeloma (NDMM): Results of the Randomized, Double-Blinded, Placebo-Controlled SWOG Trial S0232
Jeffrey A. Zonder, MD
Karmanos Cancer Institute
Detroit, Michigan

Dr. Waage - Melphalan-Prednisone-Thalidomide to Newly Diagnosed Patients with Multiple Myeloma: A Placebo Controlled Randomised Phase 3 Trial
Anders Waage, MD
University Hospital
Trondheim, Norway

Relapsed/Refractory Myeloma
Dr. San Miguel - Dexamethasone Dose Adjustments Seem To Result in Better Efficacy and Improved Tolerability in Patients with Relapsed/Refractory Multiple Myeloma Who Are Treated with Lenalidomide/Dexamethasone (MM009/010 Sub-Analysis)
Jesús San Miguel, MD
Hospital Clinico Universitario
Universidad de Salamanca
Salamanca, Spain
Member, IMF Board of Scientific Advisors

Dr. Jagannath - Updated Survival Analyses after Prolonged Follow-Up of the Phase 2, Multicenter CREST Study of Bortezomib in Relapsed or Refractory Multiple Myeloma
Sundar Jagannath, MD
St. Vincent's Comprehensive Cancer Center
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Member, IMF Board of Scientific Advisors

Dr. Bladé - The Prolonged Time to Progression with Pegylated Liposomal Doxorubicin + Bortezomib Versus Bortezomib Alone in Relapsed or Refractory Multiple Myeloma Is Unaffected by Extent of Prior Therapy or Previous Anthracycline Exposure
Joan Bladé, MD
Hospital Clinic
Hematology
Barcelona, Spain
Member, IMF Board of Scientific Advisors

Dr. Davies - The Combination of Velcade, Idarubicin and Melphalan (VIM) Demonstrates Significant Clinical Activity in Relapsed/Refractory Myeloma Patients
Faith E. Davies, MD
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, UK
Member, IMF Board of Scientific Advisors

Dr. Orlowski: Early Normalization of Serum Free Light Chain Is Associated with Prolonged Time to Progression Following Bortezomib Pegylated Liposomal Doxorubicin Treatment of Relapsed/Refractory Multiple Myeloma
Robert Z. Orlowski, MD
MD Anderson Cancer Center
Houston, Texas

Dr. Jakubowiak - A Multiple Myeloma Research Consortium (MMRC) Multicenter Phase I Trial of Perifosine (KRX-0401) in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (MM): Updated Results
Andrzej Jakubowiak, MD
University of Michigan Cancer Center
Ann Arbor, MI

New Agents
Dr. Richardson - Tanespimycin (T) + Bortezomib (BZ) in Multiple Myeloma (MM): Confirmation of the Recommended Dose Using a Novel Formulation
Paul Richardson, MD
Jerome Lipper Myeloma Center
Dana Farber Cancer Institute
Boston, MA
Member, IMF Board of Scientific Advisors

Dr. Orlowski - Safety and Antitumor Efficacy of the Proteasome Inhibitor Carfilzomib (PR-171) Dosed for Five Consecutive Days in Hematologic Malignancies: Phase 1 Results
Robert Z. Orlowski, MD
MD Anderson Cancer Center
Houston, Texas

Dr. Ocio - Antimyeloma Efficacy of Plitidepsin (Aplidin): From Bench to the Bedside
Enrique M. Ocio, MD
Hospital Universitario de Salamanca
Salamanca, Spain

Dr. Richardson - An Overview of Studies of the New Agent Perifosine (KRX-0401) Alone and in Combination for Patients with Relapsed/Refractory Multiple Myeloma
Paul Richardson, MD
Jerome Lipper Myeloma Center
Dana Farber Cancer Institute
Boston, MA
Member, IMF Board of Scientific Advisors

Dr. Richardson - Final Results of a Phase I Trial of Oral Vorinostat (Suberoylanilide Hydroxamic Acid, SAHA) in Patients with Advanced Multiple Myeloma
Paul Richardson, MD
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Dana Farber Cancer Institute
Boston, MA
Member, IMF Board of Scientific Advisors

Dr. Ocio - Triple Combinations of the HDAC Inhibitor Panobinostat (LBH589) + Dexamethasone with Either Lenalidomide or Bortezomib Are Highly Effective in a Multiple Myeloma Mouse Model
Enrique M. Ocio, MD
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Dr. Dispenzieri - Pre-Clinical Data and Preliminary Patient Results of Intravenous MV-NIS To Treat Relapsed, Refractory Multiple Myeloma
Angela Dispenzieri, MD
Mayo Clinic
Rochester, Minnesota

Dr. Davies - Aminopeptidase Inhibition as a Targeted Treatment Strategy in Myeloma
Faith E. Davies, MD
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, UK
Member, IMF Board of Scientific Advisors

Dr. Zonder - Phase I Trial of HuLuc63 in Multiple Myeloma
Jeffrey A. Zonder, MD
Karmanos Cancer Institute
Detroit, Michigan

Dr. Aggarwal: Curcumin downregulates NF-kB and related genes in patients with multiple myeloma: Results of a phase 1/2 study
Bahrat Aggarwal, PhD
MD Anderson Cancer Center
Houston, Texas

Transplantation
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Jean Luc Harousseau, MD
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CHU Hotel Dieu
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Dr. Bruno - An Update of a Comparison of Nonmyeloablative Allografting with Autografting for Newly Diagnosed Myeloma
Benedetto Bruno, MD, PhD
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Dr. Hajek - Consolidation Therapy Based on Conventional Chemotherapy and Corticoids Do Not Provide Therapeutic Advantage for Newly Diagnosed Patients after Autologous Transplantation
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University Hospital Brno
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Dr. Tosi - Superiority of Double over Single Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma and Prognostic Impact of Complete Response: Final Analysis of Bologna 96 Study
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Dr. Ladetto - Consolidation with Bortezomib, Thalidomide and Dexamethasone Induces Molecular Remissions in Autografted Multiple Myeloma Patients
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Dr. Tosi - Bortezomib (Velcade)-Thalidomide-Dexamethasone (VTD) vs Thalidomide-Dexamethasone (TD) in Preparation for Autologous Stem-Cell (SC) Transplantation (ASCT) in Newly Diagnosed Multiple Myeloma
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Dr. Einsele - An Overview of Two Studies Conducted at the University Clinic of Würzburg
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Dr. Liebisch - Prognostic Impact of Chromosomal Abnormalities in Elderly Patients with Multiple Myeloma Treated with High-Dose Melphalan (MEL140) and Autologous Stem Cell Transplantation
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New Approaches
Dr. Avet-Loiseau - High-Resolution Genomic Profiles Identify Novel Genes and/or Chromosomal Regions with Prognostic and Oncogenic Significance in Myeloma Patients
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Dr. Kyle - Monoclonal Gammopathy of Undetermined Significance: Estimated Incidence and Duration Prior to Recognition
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Dr. Kumar - Improving Survival in Multiple Myeloma: Impact of Novel Therapies
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Dr. Jakubowiak - Targeted Therapy Against Clonogenic Myeloma Cells with Iodine I-131 Tositumomab (Bexxar™).
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Dr. Kyle - Prognostic Value of the Serum Free Light Chain Ratio in Patients with Newly Diagnosed Myeloma: Proposed Incorporation into the International Staging System.
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Dr. Goldschmidt - Angiogenic Signature of Multiple Myeloma Determined by Gene Expression Profiling
Hartmut Goldschmidt, MD
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University of Heidelberg
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Member, IMF Board of Scientific Advisors