Purpose

The purpose of this study is to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with newly diagnosed [ND] multiple myeloma (MM) and participants with relapsed/refractory [R/R] MM.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Is 18 years of age or older.

Is experiencing the following:

1. Newly diagnosed MM within 3 months from initiation of treatment with documented month and year of diagnosis, criteria met for diagnosis, stage, and MM-directed treatment history, including duration, or

2. Relapsed/refractory MM who have received 1 to 3 prior lines of therapy with documented data in the medical record regarding diagnosis (month and year), the regimens used in 1st, 2nd, and 3rd line as applicable, whether stem cell transplant was part of 1st, 2nd, and 3rd line of therapy, whether consolidation/maintenance was part of 1st, 2nd, and 3rd line of therapy, also whether investigational therapy/treated on a clinical trial was part of any of these regimens.

Is willing and able to sign informed consent to participate. Is willing and able to complete patient-reported outcomes (PROs) in accordance with local regulatory and data protection requirements.

Exclusion Criteria

Is reporting to a site in this study for a second opinion (consultation only) or participants whose frequency of consult and follow-up are not adequate for quarterly electronic case report form (eCRF) completion.

Has participated in another study (observational or interventional) that prohibits participation in this study.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Relapsed/refractory (R/R) MM Patients who have received 1 to 3 prior lines of therapy
  • Other: No Intervention
Newly diagnosed (ND) MM Patients within 3 months from initiation of treatment
  • Other: No Intervention

Recruiting Locations

CARTI Cancer Center
Little Rock, Arkansas 72205

University of Arkansas For Medical Sciences
Little Rock, Arkansas 72205

University of California San Diego
La Jolla, California 92093

St Joseph Heritage Healthcare
Santa Rosa, California 95403

Rocky Mountain Cancer Centers (Williams) - USOR
Denver, Colorado 80218

Poudre Valley Health System
Fort Collins, Colorado 80528

George Washington University
Washington, District of Columbia 20037

SCRI Florida Cancer Specialists East
Daytona Beach, Florida 32117

SCRI Florida Cancer Specialists South
Fort Myers, Florida 33916

SCRI Florida Cancer Specialists North
Saint Petersburg, Florida 33705

Illinois Cancer Specialists (Niles) - USOR
Niles, Illinois 60714

Indiana University
Indianapolis, Indiana 46202

East Jefferson General Hospital
Metairie, Louisiana 70006

Central Maine Medical Center
Lewiston, Maine 4240

Maryland Oncology Hematology (Columbia) - USOR
Columbia, Maryland 21044

Barbara Ann Karmanos Cancer Center
Detroit, Michigan 48201

Park Nicollet Institute
Saint Louis Park, Minnesota 55416

Central Care Cancer Center
Bolivar, Missouri 65613

Kansas City VA Medical Center
Kansas City, Missouri 64128

Washington University in St. Louis
Saint Louis, Missouri 63110

Hunterdon Hematology Oncology
Flemington, New Jersey 8822

San Juan Oncology Associates
Farmington, New Mexico 87401

Saint Francis Hospital
East Hills, New York 11576

Mount Sinai Medical Center
New York, New York 10029

Levine Cancer Center
Charlotte, North Carolina 28402

University of Cincinnati
Cincinnati, Ohio 45220

Hematology Oncology Associates - USOR
Medford, Oregon 97504

Northwest Cancer Specialists (Broadway) - USOR
Portland, Oregon 97227

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111

Veterans Affairs Pittsburgh Healthcare System
Pittsburgh, Pennsylvania 15240

Greenville Health System Cancer Institute
Greenville, South Carolina 29615

SCRI Tennessee Oncology Nashville
Nashville, Tennessee 37203

Texas Oncology (Loop) - USOR
Amarillo, Texas 79106

Texas Oncology (Loop) - USOR
Dallas, Texas 92056

Texas Oncology (Loop) - USOR
El Paso, Texas 79902

University of Texas MD Anderson Cancer Center
Houston, Texas 77030

Texas Oncology (Loop) - USOR
Round Rock, Texas 78681

Texas Oncology (Loop) - USOR
San Antonio, Texas 78217

Yakima Valley Memorial Hospital North Star Lodge - USOR
Yakima, Washington 98902

Berkeley Medical Center
Martinsburg, West Virginia 25401

St Vincent Hospital
Green Bay, Wisconsin 54307

University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792

Aurora Health Care, Aurora Cancer Care
Milwaukee, Wisconsin 53215

More Details

NCT ID
NCT02761187
Status
Recruiting
Sponsor
Takeda

Study Contact

Takeda Study Registration Call Center
1-866-835-2233
GlobalOncologyMedinfo@takeda.com

Detailed Description

This is a prospective, non-interventional, observational study. This study will look at contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with MM. Participants will not be asked to change their routine clinical treatment. Participants will have to complete patient reported outcomes (PROs) surveys during on-site routine office visits.

The study will enroll approximately 4200 participants. Participants will be assigned to one of the following cohorts based upon the diagnosis of MM:

- ND MM within 3 months from initiation of treatment

- R/R MM who have received 1 to 3 prior lines of therapy

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 8 years. Participants will be evaluated and followed-up for a period of at least 5 years, until death, are lost to follow-up, or the end of the study, whichever comes first.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.