Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:8/18/2018
Start Date:July 2011
End Date:September 2023

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A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple Myeloma (MM) Patients to Assess the Relationship Between Patient Outcomes, Treatment Regimens and Molecular Profiles

The primary objective of this observational study is to identify the molecular profiles and
clinical characteristics that define subsets of myeloma patients during the course of the
disease.

Understanding the molecular basis of cancer is a critical step toward devising the most
effective treatment of the patient as an individual. The promise of molecular targeted
therapeutics and personalized cancer care has been demonstrated in breast and lung cancer and
chronic myeloid leukemia. However, similar examples of success in multiple myeloma have not
been achieved despite extensive basic research as well as clinical advances. What is well
understood is that myeloma is a heterogeneous disease with great genetic and epigenetic
complexity.22, 23 Therefore, there remains a critical need to understand myeloma patient
biology in the context of current patient care.24 The objective of this longitudinal study is
to identify patient subgroups and phenotypes defined by molecular profiling and clinical
features. These profiles will enable a better understanding of mechanisms of disease, drug
response and patient relapse. Ultimately the study is intended to drive successful drug
development and patient care in multiple myeloma.

Inclusion Criteria:

- Patient is at least 18 years old.

- Patient has been diagnosed with symptomatic MM with measurable disease that includes
at least one of the following:

Serum M protein ≥ 1g/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).

- The patient is a candidate for systemic therapy that includes an IMiD® (e.g.,
lenalidomide, pomalidomide, thalidomide) and/or proteasome inhibitor (e.g.,
bortezomib, carfilzomib) as part of the initial regimen.

- No more than 30 days from baseline bone marrow evaluation as per this protocol to
initiation of first-line therapy.

- Patient has read, understood and signed informed consent.

Exclusion Criteria:

- Patient is already receiving systemic therapy for MM (a single dose of bisphosphonates
and up to 100 mg total dose of dexamethasone or equivalent corticosteroids are
permitted prior to registration on study).

- Patient had another malignancy within the last 5 years (except for basal or squamous
cell carcinoma, or in situ cancer of the cervix).

- Patient is enrolled 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.
We found this trial at
56
sites
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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433 Southwest 10th Street
Ocala, Florida 34471
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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801 North 29th Street
Billings, Montana 59107
406-238-2500
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Bronx, New York 10469
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Cary, North Carolina 27511
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Charlotte, North Carolina 28211
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Decatur, Georgia 30033
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Denver, Colorado 80205
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Denver, Colorado 80218
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Durham, North Carolina 27705
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Fairfax, Virginia 22013
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25 Michigan St. NE, Suite 3100
Grand Rapids, Michigan 49503
(616) 391-1230
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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Johnson City, New York 13790
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Kansas City, Missouri 64128
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Marshfield, Wisconsin 54449
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
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New York, New York 10029
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New York, New York 10021
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Niles, Illinois 60714
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Pinehurst, North Carolina 28374
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Roslyn, New York 11576
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Saint Louis, Missouri 63110
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Salisbury, Maryland 21801
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100 NE Loop 410; Suite 600
San Antonio, Texas 78216
210-424-1600
Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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San Diego, California 92123
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San Diego, California 92093
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3350 La Jolla Village Dr
San Diego, California 92161
(858) 552-8585
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Spokane, Washington 99218
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Stamford, Connecticut 06902
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Tualatin, Oregon 97062
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Tyler, Texas 75702
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Waco, Texas 76712
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Washington, District of Columbia 20422
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
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2811 Tieton Drive
Yakima, Washington 98902
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