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
Anaheim, California 92801
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Amarillo, Texas 79106
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Birmingham, Alabama 35294
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Brooksville, Florida 34613
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Canton, Ohio 44718
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Cary, North Carolina 27518
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Charleston, South Carolina 29414
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Cleveland, Ohio 44109
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Corona, California 92879
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Corpus Christi, Texas 78350
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Dallas, Texas 75231
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Dallas, Texas 75231
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Dallas, Texas 75231
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Gastonia, North Carolina 28054
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Goodyear, Arizona 85338
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Jacksonville, Florida 32256
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Kansas City, Missouri 64132
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Knoxville, Tennessee 37920
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Lafayette, Louisiana 70503
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Los Angeles, California 90013
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Louisville, Kentucky 40201
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Memphis, Tennessee 38103
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Minneapolis, Minnesota 55416
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Missoula, Montana 59807
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Missoula, Montana 59807
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Omaha, Nebraska 68124
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Portland, Oregon
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Pottstown, Pennsylvania 19464
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Saint Joseph, Missouri 64501
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Saint Louis, Missouri 63104
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San Antonio, Texas 78217
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Santa Rosa, California 95403
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Seattle, Washington 98101
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Sherman, Texas 75090
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Shreveport, Louisiana 71103
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Sioux City, Iowa 51101
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Skokie, Illinois 60077
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Southaven, Mississippi 38671
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Spokane, Washington 99202
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Springfield, Missouri 65804
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18 King Street East
Toronto, Ontario M5C 1C4
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Tulsa, Oklahoma 74136
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Valdosta, Georgia 31602
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Yakima, Washington 98901
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Yakima, Washington 98901
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