Multiple Myeloma Patient Registry

NCT ID: NCT03180853

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-08

Study Completion Date

2018-04-06

Brief Summary

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The purpose of this study is to document the participants characteristics, disease burden, and clinical management of participants in the United States who are treated for relapsed multiple myeloma in routine medical practice with a treatment strategies that include a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Relapsed Multiple Myeloma Participants

The participants in the United States with a confirmed diagnosis of relapsed multiple myeloma following 1 to 3 prior lines of therapy who initiate treatment with a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments as per routine clinical practice within 90 days prior to study enrollment. These participants will be observed for the sequence of systemic myeloma treatments used during routine clinical practice, considering the life expectancy of patients with myeloma in the registry.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
* Have a diagnosis of relapsed MM \[according to 2014 International Myeloma Working Group (IMWG) criteria\] with 1 to 3 prior lines of therapy. (An induction regimen followed by autologous stem cell transplantation and single-agent maintenance therapy will be considered a single line of therapy.)
* Participants must have initiated a new line of induction therapy that includes a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) within 90 days prior to enrollment. A short course of corticosteroids is allowed prior to initiating the new line of induction therapy
* Must be willing and able to complete the protocol-required patient-reported outcome (PROs)

Exclusion Criteria

* Participant has plasma cell leukemia \[greater than (\>) 2.0 \* 10\^9 per liter\] circulating plasma cells by standard differential), Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and/or skin changes), or amyloid light-chain amyloidosis
* Participant has a life expectancy of less than 6 months
* At the time of screening, participant is enrolled in an interventional clinical trial for MM using an anti-neoplastic agent that is not currently approved by the United States (US) Food and Drug Administration (FDA)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Scientific Affairs, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Scientific Affairs, LLC

Locations

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Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, United States

Site Status

Mercy Research

Fort Smith, Arkansas, United States

Site Status

Genesis Cancer Center

Hot Springs, Arkansas, United States

Site Status

St. Bernard's Medical Center

Jonesboro, Arkansas, United States

Site Status

CARTI

Little Rock, Arkansas, United States

Site Status

Facey Medical Group

Mission Hills, California, United States

Site Status

North County Oncology

Oceanside, California, United States

Site Status

Ventura County Hematology Oncology Specialists

Oxnard, California, United States

Site Status

James R. Berenson, MD Inc.

West Hollywood, California, United States

Site Status

PIH Health Hospital

Whittier, California, United States

Site Status

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Site Status

University Cancer Institute (UCI)

Boynton Beach, Florida, United States

Site Status

Southeast Florida Hematology Oncology Group

Fort Lauderdale, Florida, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Site Status

Watson Clinic Llp

Lakeland, Florida, United States

Site Status

Ocala Oncology Center

Ocala, Florida, United States

Site Status

Piedmont Cancer Institute

Atlanta, Georgia, United States

Site Status

Augusta University

Augusta, Georgia, United States

Site Status

Gwinnett Hospital System, Inc

Lawrenceville, Georgia, United States

Site Status

Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs Candler Health System

Savannah, Georgia, United States

Site Status

Ingalls Memorial Hospital Cancer Research Center

Harvey, Illinois, United States

Site Status

Orchard Healthcare Research

Skokie, Illinois, United States

Site Status

Baptist Healthcare Systems, Inc. d/b/a Baptist Health Floyd

New Albany, Indiana, United States

Site Status

Physicians' Clinic of Iowa, P.C at PCI Main Building

Cedar Rapids, Iowa, United States

Site Status

Commonwealth Hematology-Oncology, P.C.

Danville, Kentucky, United States

Site Status

Hardin Memorial Hospital

Elizabethtown, Kentucky, United States

Site Status

Kentucky Cancer Care

Hazard, Kentucky, United States

Site Status

Oncology Associates of West Kentucky

Paducah, Kentucky, United States

Site Status

West Kentucky Hematology-Oncology

Paducah, Kentucky, United States

Site Status

Pontchartrain Cancer Center

Covington, Louisiana, United States

Site Status

Tulane University Hospital & Clinics

New Orleans, Louisiana, United States

Site Status

Mercy Medical Center

Baltimore, Maryland, United States

Site Status

Meritus Center for Clinical Research

Hagerstown, Maryland, United States

Site Status

Reliant Medical Group, Inc.

Worcester, Massachusetts, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

MidMichigan Health Cancer Center

Midland, Michigan, United States

Site Status

Providence Cancer Center

Southfield, Michigan, United States

Site Status

St. Luke's Speciality Clinic

Duluth, Minnesota, United States

Site Status

Singing River Health System

Pascagoula, Mississippi, United States

Site Status

Trinitas Comprehensive Cancer Center

Elizabeth, New Jersey, United States

Site Status

Southern Oncology Hematology Associates

Williamstown, New Jersey, United States

Site Status

North Shore Hematology Oncology Associates, P.C.

East Setauket, New York, United States

Site Status

Hudson Valley Hematology Oncology Associates

Poughkeepsie, New York, United States

Site Status

Community Health Network

Rochester, New York, United States

Site Status

Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center

Columbus, Ohio, United States

Site Status

Dayton Physicians, LLC

Kettering, Ohio, United States

Site Status

Good Samaritan Hospital Corvallis

Corvallis, Oregon, United States

Site Status

Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

Lehigh Valley Health network (Oncology)

Bethlehem, Pennsylvania, United States

Site Status

Hematology and Oncology Associates of NEPA

Dunmore, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Aria Health- Torresdale

Philadelphia, Pennsylvania, United States

Site Status

Charleston Cancer Center

Charleston, South Carolina, United States

Site Status

Carolina Blood and Cancer Care

Rock Hill, South Carolina, United States

Site Status

Wellmont Blue Ridge Medical Specialists

Bristol, Tennessee, United States

Site Status

Jackson Madison County General Hospital

Jacksonville, Tennessee, United States

Site Status

Texas Oncology P A

Arlington, Texas, United States

Site Status

Texas Oncology P A

Beaumont, Texas, United States

Site Status

Texas Oncology P A

Denton, Texas, United States

Site Status

Texas Oncology P A

Flower Mound, Texas, United States

Site Status

Texas Oncology-Memorial City

Houston, Texas, United States

Site Status

Texas Oncology P A

Paris, Texas, United States

Site Status

Texas Oncology P A

Plano, Texas, United States

Site Status

Texas Oncology P A

Tyler, Texas, United States

Site Status

Texas Oncology P A

Waco, Texas, United States

Site Status

Texas Oncology P A

Webster, Texas, United States

Site Status

Texas Oncology P A

Wichita Falls, Texas, United States

Site Status

Kadlec Clinic Hematology & Oncology

Kennewick, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NOPRODMMY4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108326

Identifier Type: -

Identifier Source: org_study_id

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