Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)



Status:Recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:9/29/2018
Start Date:June 13, 2012
End Date:June 13, 2024
Contact:Michelle Grossman, BS
Email:Michelle.Grossman@parexel.com
Phone:781 269 5276

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This is a non-interventional observational study aimed at understanding the real world
effectiveness of novel agents used in treating multiple myeloma and their impact on
patient-reported outcomes. This study will collect information that is already in medical
records regarding treatment and diagnostic procedures. Patients are asked to complete
questionnaires for patient-reported outcome measures.

This is a prospective, multi-regional, observational cohort study with up to 3 years of
follow up per patient. During the entire observational period (from the first patient first
visit to the last patient last visit), vital status will be collected every 6 months on all
patients, including those who complete the 3-year follow up prior to study conclusion. The
study will include 3 cohorts of patients receiving one of the following classes of treatments
for MM:

- IMiDs

- Proteasome inhibitors

- Combination novel therapies (an IMiD plus a proteasome inhibitor)

- Additional use of corticosteroids and/or cytotoxic agents (eg, alkylating agents)
is permitted for all 3 cohorts.

Medicines that are prescribed in a manner that is consistent with the terms of the approved
marketing authorization or in line with the current standard of practice of the participating
physician will be allowed.

Note : Treatment with the current regimen:

i. must have been initiated within 90 days before consent for this study OR ii. in the case
where treatment has not yet been initiated, documentation that the treatment strategy was
determined before consent for this study must be provided, and treatment must be initiated
within 30 days after consent.

Enrollment of approximately 1000 patients will occur during an approximate 36-month
timeframe, and each patient will be followed for up to 3 years.

Inclusion Criteria:

- Patients diagnosed with relapsed or refractory MM who have received at least one prior
line of therapy for MM

- Age of 18 years (or legal age of consent) or older at time of entry into the study

- Have documented progression from a prior line of therapy

- Patients who have initiated treatment with one of the following therapies within 90
days before consent for this study OR in the case where treatment has not yet been
initiated, documentation that the treatment strategy was determined before consent for
this study must be provided, and treatment must be initiated within 30 days after
consent:

IMiD* Proteasome inhibitor* Combination novel therapies (an IMiD plus a proteasome
inhibitor)*

Exclusion Criteria:

- Patients who are currently participating in a clinical trial for MM

- Patients who are not willing or able to provide informed consent

- Patients who are incarcerated

- Patients under compulsory detention for treatment of a physical (eg, infectious) or
psychiatric illness Patients who are currently receiving treatment for primary cancer
other than multiple myeloma
We found this trial at
46
sites
Missoula, Montana 59807
907
mi
from 91732
Missoula, MT
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Amarillo, Texas 79106
918
mi
from 91732
Amarillo, TX
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Anaheim, California 92801
17
mi
from 91732
Anaheim, CA
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Birmingham, Alabama 35294
1785
mi
from 91732
Birmingham, AL
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Brooksville, Florida 34613
2113
mi
from 91732
Brooksville, FL
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Canton, Ohio 44718
2042
mi
from 91732
Canton, OH
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Cary, North Carolina 27518
2211
mi
from 91732
Cary, NC
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Charleston, South Carolina 29414
2175
mi
from 91732
Charleston, SC
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Cleveland, Ohio 44109
2031
mi
from 91732
Cleveland, OH
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Corona, California 92879
30
mi
from 91732
Corona, CA
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Corpus Christi, Texas 78350
1250
mi
from 91732
Corpus Christi, TX
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Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
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Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
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Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
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Gastonia, North Carolina 28054
2084
mi
from 91732
Gastonia, NC
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Goodyear, Arizona 85338
326
mi
from 91732
Goodyear, AZ
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Indianapolis, Indiana 46260
1791
mi
from 91732
Indianapolis, IN
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Jacksonville, Florida 32256
2138
mi
from 91732
Jacksonville, FL
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Kansas City, Missouri 64132
1341
mi
from 91732
Kansas City, MO
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Knoxville, Tennessee 37920
1927
mi
from 91732
Knoxville, TN
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Lafayette, Louisiana 70503
1537
mi
from 91732
Lafayette, LA
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Los Angeles, California 90013
13
mi
from 91732
Los Angeles, CA
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Louisville, Kentucky 40201
1812
mi
from 91732
Louisville, KY
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Memphis, Tennessee 38103
1585
mi
from 91732
Memphis, TN
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Minneapolis, Minnesota 55416
1505
mi
from 91732
Minneapolis, MN
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Missoula, Montana 59807
907
mi
from 91732
Missoula, MT
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Omaha, Nebraska 68124
1294
mi
from 91732
Omaha, NE
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Portland, Oregon
828
mi
from 91732
Portland, OR
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Pottstown, Pennsylvania 19464
2348
mi
from 91732
Pottstown, PA
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Saint Joseph, Missouri 64501
1334
mi
from 91732
Saint Joseph, MO
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Saint Louis, Missouri 63104
1571
mi
from 91732
Saint Louis, MO
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San Antonio, Texas 78217
1189
mi
from 91732
San Antonio, TX
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Santa Rosa, California 95403
402
mi
from 91732
Santa Rosa, CA
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Seattle, Washington 98101
961
mi
from 91732
Seattle, WA
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Sherman, Texas 75090
1226
mi
from 91732
Sherman, TX
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Shreveport, Louisiana 71103
1401
mi
from 91732
Shreveport, LA
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Sioux City, Iowa 51101
1303
mi
from 91732
Sioux City, IA
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Skokie, Illinois 60077
1724
mi
from 91732
Skokie, IL
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Southaven, Mississippi 38671
1591
mi
from 91732
Southaven, MS
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Spokane, Washington 99202
939
mi
from 91732
Spokane, WA
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Springfield, Missouri 65804
1403
mi
from 91732
Springfield, MO
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18 King Street East
Toronto, Ontario M5C 1C4
2159
mi
from 91732
Toronto,
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Tulsa, Oklahoma 74136
1252
mi
from 91732
Tulsa, OK
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Valdosta, Georgia 31602
2027
mi
from 91732
Valdosta, GA
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Yakima, Washington 98901
875
mi
from 91732
Yakima, WA
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Yakima, Washington 98901
875
mi
from 91732
Yakima, WA
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