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Microsoft powerpoint - mmrf_commpass_2g_dcl [compatibility mode]

The Multiple Myeloma Research Foundation CoMMpass Study
Sagar Lonial, MD
A Prospective, Longitudinal,
Observational Study in Newly
Diagnosed Multiple Myeloma Patients
to Assess the Relationship Between
Patient Outcomes, Treatment
Regimens, and Molecular Profiles
The Multiple Myeloma Research Foundation
CoMMpass Study
Sagar Lonial, MD
Co-Principal Investigator
Emory University
Atlanta, Georgia
Introduction
Purpose
To identify the molecular profiles and clinical
characteristics that define subsets of myeloma
patients at initial diagnosis and at relapse of disease

Primary outcome
Response rate (as defined by International Myeloma
Working Group criteria), progression-free survival,
overall survival, health-related quality of life, and
biologic profiling and genomic marker studies on
bone marrow tumor cells and peripheral blood at
baseline pre-treatment, at first subsequent
relapse/progression, and at suspected complete
response

This material serves as an educational resource only.
The Multiple Myeloma Research Foundation CoMMpass Study
Sagar Lonial, MD
Longitudinal Study Designed to Identify Patient
Segments Based on Molecular Profiling
CoMMpass Trial
Target enrollment:
>1,000 newly diagnosed patients

Clinical data and
tissue profiling

Core molecular tests:
Duration:
Flow cytometry
~13 years (3-year enrollment
RNA sequencing expression analysis
+ 5-year full F/U and 5=year
Whole-exome DNA sequencing
survival F/U)
Whole-genome chromosome analysis
Cytospin slides for FISH
Target 50 centers
PCC Partners
Onyx, Millennium, BMS, JNJ

CoMMpass, Relating Clinical Outcomes in MM to Personal Assessment of Genetic Profile
Inclusion Criteria
Male/female ≥18 years of age
Symptomatic multiple myeloma with measurable
disease that includes at least one of the following:
Serum M protein ≥1 g/dL
Urine M protein ≥200 mg/24 hrs
Involved free light chain level ≥10 mg/dL and an abnormal
serum free light chain ratio (<0.26 or >1.65)
Candidate for systemic therapy that includes an
immunomodulator drug (IMiD) and/or proteasome
inhibitor as part of the initial regimen

No more than 30 days from baseline bone marrow
evaluation to initiation of therapy
Be able to read, understand, and sign the Informed
Consent document
This material serves as an educational resource only.
The Multiple Myeloma Research Foundation CoMMpass Study
Sagar Lonial, MD
Exclusion Criteria
Currently receiving systemic therapy for multiple
Please note that a single dose of bisphosphonates and up
to 100 mg total dose of dexamethasone or equivalent
corticosteroids are permitted prior to study registration.

Prior (within the last 5 years) malignancy
Exceptions include basal or squamous cell carcinoma or in
situ cancer of the cervix
Enrollment in a blinded clinical trial for the first-line
treatment of multiple myeloma
Patients may be enrolled in subsequent clinical trials as
long as continued access to data and tissue, as per this
protocol, is not prohibited

Trial Schema
Active multiple myeloma, newly diagnosed, untreated
(n=1,000)
Clinical
end points: Baseline
Treatment 1 Response
Relapse/progression
Treatment 2 CR/Relapse/PD
First-line therapy:
≥Second-line
IMiD, proteasome
therapy: (single
inhibitor, GC (single
or comb.)
or comb.)
Clinical study
Biospecimen
colletion:
This material serves as an educational resource only.
The Multiple Myeloma Research Foundation CoMMpass Study
Sagar Lonial, MD
Biospecimen Workflow
Isolation of tumor
Speciment collection
cells: CD138+ MM
and processing
(<24 h)
purification
Whole-genome
Isolation of control
cells: CD3+ T cells
Whole-exome
Bone marrow aspirate
Circulating tumor
+ peripheral blood
Specimen QC:
Cytomorphology
flow cytometry,
PI, DNA ploidy
Immunophenotyping
%PC, %CD138…et al
BioRepository:
(MM panel)
CD138+/CD138-/PBL CD3+
DNA/RNA/protein/plasma
%PC, %CD138…et al
cell cryopreservation
CoMMpass Genomics
Bringing state-of-the-art next-generation sequencing to
MM patients at both community and academic centers
Patients can
Community
Academic
MMRF CoMMpass
obtain w/o
academic &
physician
availability
availability
community centers
Exome normal tissue
sequencing
MM tumor purification and
MM tumor exome
sequencing
MM tumor RNA sequencing
MM tumor flow cytometry
• yes, paid by patient
* Insurance reimbursement is evolving
may be paid as part of research program
+/- ordered by a limited number of centers

This material serves as an educational resource only.
The Multiple Myeloma Research Foundation CoMMpass Study
Sagar Lonial, MD
CoMMpass Data
We will be performing interim
analyses of the data every 6 months.
Contact Information
For more information on becoming a site, or
if you would like to refer a patient to the
MMRF CoMMpass Study, please contact
Beverly Harrison at HarrisonB@themmrc.org
or call 203.652.0213

Relating Clinical Outcomes in Multiple Myeloma to
Personal Assessment of Genetic Profile (CoMMpass)
NCT01454297
This material serves as an educational resource only.
The Multiple Myeloma Research Foundation CoMMpass Study
Sagar Lonial, MD
If you want to learn more, you are
invited to attend a CME-certified
regional lecture series
A Personalized Approach to Multiple
Myeloma Treatment
Call toll-free: (888) 576-6968
to participate in a city near you:
Chicago, Illinois
Atlanta, Georgia
New York, New York
This material serves as an educational resource only.

Source: http://www.oncology.tv/portals/0/linkedFiles/MMRF_Community_Case_Discussion.pdf

Microsoft word - tingey formal research proposal

CAFFEINE’S EFFECT ON VISUAL INPUT Caffeine’s Effect on Certain Visual Sensory Input CAFFEINE’S EFFECT ON VISUAL INPUT This study will explore caffeine’s effect on the rate of eye movement while reading. To measure rate of eye movement, one must examine rate of saccades, or small movements of the eye that occur when a person reads, looks at a scene or searches for an object.

anepe.org

Diário da República, 1.ª série — N.º 77 — 19 de Abril de 2011 MINISTÉRIO DA AGRICULTURA, DO DESENVOLVIMENTO Os outorgantes da convenção requereram a extensão RURAL E DAS PESCAS da mesma a todas as empresas do sector de actividade abrangido e aos trabalhadores ao seu serviço. A convenção actualiza a tabela salarial. Não foi possível Portaria n.º 165/2011 avaliar

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