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

Use our guide to learn which trials are right for you!

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
Springfield, Missouri 65804
?
mi
from
Springfield, MO
Click here to add this to my saved trials
Amarillo, Texas 79106
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Anaheim, California 92801
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Birmingham, Alabama 35294
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Brooksville, Florida 34613
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
Canton, Ohio 44718
?
mi
from
Canton, OH
Click here to add this to my saved trials
Cary, North Carolina 27518
?
mi
from
Cary, NC
Click here to add this to my saved trials
Charleston, South Carolina 29414
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Cleveland, Ohio 44109
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Corona, California 92879
?
mi
from
Corona, CA
Click here to add this to my saved trials
Corpus Christi, Texas 78350
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Gastonia, North Carolina 28054
?
mi
from
Gastonia, NC
Click here to add this to my saved trials
Goodyear, Arizona 85338
?
mi
from
Goodyear, AZ
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kansas City, Missouri 64132
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Knoxville, Tennessee 37920
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lafayette, Louisiana 70503
?
mi
from
Lafayette, LA
Click here to add this to my saved trials
Los Angeles, California 90013
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40201
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Memphis, Tennessee 38103
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Minneapolis, Minnesota 55416
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Missoula, Montana 59807
?
mi
from
Missoula, MT
Click here to add this to my saved trials
Missoula, Montana 59807
?
mi
from
Missoula, MT
Click here to add this to my saved trials
Omaha, Nebraska 68124
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Portland, Oregon
?
mi
from
Portland, OR
Click here to add this to my saved trials
Pottstown, Pennsylvania 19464
?
mi
from
Pottstown, PA
Click here to add this to my saved trials
Saint Joseph, Missouri 64501
?
mi
from
Saint Joseph, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63104
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78217
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Santa Rosa, California 95403
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
Seattle, Washington 98101
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Sherman, Texas 75090
?
mi
from
Sherman, TX
Click here to add this to my saved trials
Shreveport, Louisiana 71103
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Sioux City, Iowa 51101
?
mi
from
Sioux City, IA
Click here to add this to my saved trials
Skokie, Illinois 60077
?
mi
from
Skokie, IL
Click here to add this to my saved trials
Southaven, Mississippi 38671
?
mi
from
Southaven, MS
Click here to add this to my saved trials
Spokane, Washington 99202
?
mi
from
Spokane, WA
Click here to add this to my saved trials
18 King Street East
Toronto, Ontario M5C 1C4
?
mi
from
Toronto,
Click here to add this to my saved trials
Tulsa, Oklahoma 74136
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Valdosta, Georgia 31602
?
mi
from
Valdosta, GA
Click here to add this to my saved trials
Yakima, Washington 98901
?
mi
from
Yakima, WA
Click here to add this to my saved trials
Yakima, Washington 98901
?
mi
from
Yakima, WA
Click here to add this to my saved trials