ASH News Daily 2013 - Day 3 - (Page A-12)
Page A-12
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ASH NEWS DAILY
Monday, December 9, 2013
ASH Live: Today's Remote Session Viewing Schedule
Lounge 1: 1st Floor, Hall A Lobby, Convention Center
Channel 1
7:00 - 8:30 a.m.
Myelodysplastic
Syndromes:
Abnormalities in
Splicing and DNA Repair
in Myelodysplastic
Syndromes
Channel 2
Oncogenes and Tumor
Suppressors: Molecular
Pathogrenesis of
Leukemias - Insights
from Genomic and
Functional Studies
Channel 3
Graft Engineering
and Adoptive
Immunotherapy:
Tackling Resistance
Lymphoma: Therapy with
Biological Agents,
Excluding Pre-Clinical
Models: Novel Therapies
for Indolent Lymphomas
Channel 2
Acute Myeloid Leukemia:
Therapy, excluding
Transplantation:
Translational Studies
Channel 3
Hemoglobinopathies,
excluding Thalassemia:
Insights Into the
Pathophysiology of
Sickle Cell Disease
10:30 a.m. - Noon
Myelodysplastic
Syndromes: Novel
Therapies and Clinical
Outcomes
Myeloproliferative
Syndromes: Clinical: Clinical
Trials
2:45 - 4:15 p.m.
Myelodysplastic
Syndromes:
Genomic Studies in
Myelodysplastic
Syndromes
Oncogenes and Tumor
Suppressors: Mutations in
Epigenetic Regulators in
Leukemogenesis
A Fresh Look at Drug
Approval: Moving Away
from Tradition
Hodgkin Lymphoma:
New and Old
4:30 - 6:00 p.m.
Myelodysplastic
Syndromes: Somatic
Mutations and Their
Clinical Associations
Myeloproliferative
Syndromes: Clinical:
Novel Therapeutic
Strategies
Hodgkin Lymphoma:
Biology, excluding
Therapy: Genomics
Lounge 2: 2nd Floor, Outside New Orleans Theater, Convention Center
Channel 1
Lymphoma:
Chemotherapy,
excluding Pre-Clinical
Models: Clinical Trials
in Lymphoma
Acute Myeloid Leukemia:
Therapy, excluding
Transplantation:
Antibody-Based
Targeted Therapy
Hemoglobinopathies,
excluding Thalassemia:
Emerging Therapeutics
in Sickle Cell Disease
Lymphoma: Therapy with
Biological Agents,
Excluding Pre-Clinical
Models: Immunotherapy
for Indolent Lymphomas
Acute Myeloid Leukemia:
Therapy, excluding
Transplantation:
Clinical Studies
Thalassemia and Globin
Gene Regulation:
Targeted Engineering of
Globin Gene Expression
Lymphoma: Chemotherapy,
excluding Pre-Clinical
Models: Data in
Uncommon NHL Subtypes
and Hodgkin Lymphoma
Acute Myeloid Leukemia:
Therapy, excluding
Transplantation: Novel
Agents in Combination
with Chemotherapy
Thalassemia and Globin
Gene Regulation:
Preclinical and Clinical
Therapeutic Strategies
for Thalassemia
Hemoglobinopathies,
excluding Thalassemia:
Novel Mechanisms of
Pathophysiology in
Sickle Cell Disease
Janssen Daratumumab Clinical Trials* in Multiple Myeloma Patients
(human IgG1k monoclonal antibody that binds CD38)
GEN501 Enrolling Now
Daratumumab Safety Study in Multiple Myeloma - Open-Label,
Dose-Escalation Followed by Open-label, Single Arm Study
MONDAY
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GEN503 Enrolling Now
Open-label, Dose Escalating Phase I/II Study Investigating the
Safety of Daratumumab in Combination With Lenalidomide
and Dexamethasone in Patients With Relapsed or Relapsed and
Refractory Multiple Myeloma
54767414MMY2002 Enrolling Now
An Open-label, Multicenter**, Phase 2 Study of Daratumumab in
Subjects with Multiple Myeloma Who Have Received at Least 3 Prior
Lines of Therapy (Including a Proteasome Inhibitor and IMiD) or are
Double Refractory to a Proteasome Inhibitor and an IMiD
54767414MMY1001 Enrolling Soon
An Open-label, Multicenter**, Phase 1b Study of JNJ-54767414
(HuMax® CD38) (Anti-CD38 Monoclonal Antibody) in
Combination with Backbone Regimens for the Treatment of
Subjects with Multiple Myeloma
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Part 1:
Daratumumab in combination
with Lenalidomide and
dexamethasone
Group A - Dose 1
1:1
Daratumumab
(15 subjects)
Group B - Dose 2
Daratumumab
(15 subjects)
Part 1, Stage 1
Stage 1 results
Part 1, Stage 2
25 subjects
in 1 or both
treatment
groups, based
on Part 1,
establish the safety profile of
Dose escalation to
Part 1:
Dose escalation to
establish the safety profile
of Daratumumab
Part 2:
Evaluate different
treatment schedules to
optimize the pre-medication
and infusion parameters
6:15 - 7:45 p.m.
Myelodysplastic
Syndromes: Basic
and Clinical Insights
Part 2:
recommended dose
Cohort expansion
at the phase II
Enroll 30
subjects in
treatment
regimen with
highest response
in Part 1
Part 2
Daratumumab + Bortezomib + Dexamethasone (VD)
Daratumumab + Bortezomib + Melphalan + Prednisone (VMP)
Daratumumab + Bortezomib + Thalidomide + Dexamethasone (VTD)
Daratumumab + Pomalidomide + Dexamethasone (Pom-Dex)
**All research sites have been identified for these studies.
If you are interested in participating in future daratumumab trials and you have dedicated clinical research staff, please contact dara@its.jnj.com.
*The safety and efficacy of the investigational use of this product has not been determined. There is no guarantee that the investigational uses listed will be filed with and/or approved for marketing by any regulatory agency.
Janssen Research & Development, LLC
DARA54767414ADV-ENG01
VERSION 1.0
14OCT2013
Table of Contents for the Digital Edition of ASH News Daily 2013 - Day 3
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ASH News Daily 2013 - Day 3
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