Clinical trial NCT03180853: Multiple Myeloma Patient Registry
Official title: Multiple Myeloma Patient Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Myeloma
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2017-06-08
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants to be enrolled in this registry will be participants whose multiple myeloma (MM) has relapsed after the administration of 1 to 3 prior lines of therapy and who initiate treatment with a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments within 90 days prior to study enrollment. Participants are to be recruited from medical centers in the United States.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Overall Response Rate
timeFrame: Up to 3 years
measure: Time to Next Treatment (TTNT)
timeFrame: Up to 3 years
measure: Overall Survival (OS)
timeFrame: Up to 3 years
measure: Survival Time
timeFrame: Up to 3 years
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
timeFrame: Up to 3 years
measure: Katz Index of Independence for Activities of Daily Living
timeFrame: Up to 3 years
measure: Lawton Instrumental Activities of Daily Living
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Oncology Associates, PC - HAL
state: Arizona
city: Fort Smith
country: United States
facility: Mercy Research
state: Arkansas
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Jonesboro
country: United States
facility: St. Bernard's Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: CARTI
state: Arkansas
city: Mission Hills
country: United States
facility: Facey Medical Group
state: California
city: Oceanside
country: United States
facility: North County Oncology
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology Oncology Specialists
state: California
city: West Hollywood
country: United States
facility: James R. Berenson, MD Inc.
state: California
city: Whittier
country: United States
facility: PIH Health Hospital
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Boynton Beach
country: United States
facility: University Cancer Institute (UCI)
state: Florida
city: Fort Lauderdale
country: United States
facility: Southeast Florida Hematology Oncology Group
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Llp
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Atlanta
country: United States
facility: Piedmont Cancer Institute
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Hospital System, Inc
state: Georgia
city: Savannah
country: United States
facility: Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs Candler Health System
state: Georgia
city: Harvey
country: United States
facility: Ingalls Memorial Hospital Cancer Research Center
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research
state: Illinois
city: New Albany
country: United States
facility: Baptist Healthcare Systems, Inc. d/b/a Baptist Health Floyd
state: Indiana
city: Cedar Rapids
country: United States
facility: Physicians' Clinic of Iowa, P.C at PCI Main Building
state: Iowa
city: Danville
country: United States
facility: Commonwealth Hematology-Oncology, P.C.
state: Kentucky
city: Elizabethtown
country: United States
facility: Hardin Memorial Hospital
state: Kentucky
city: Hazard
country: United States
facility: Kentucky Cancer Care
state: Kentucky
city: Paducah
country: United States
facility: Oncology Associates of West Kentucky
state: Kentucky
city: Paducah
country: United States
facility: West Kentucky Hematology-Oncology
state: Kentucky
city: Covington
country: United States
facility: Pontchartrain Cancer Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Hospital & Clinics
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Worcester
country: United States
facility: Reliant Medical Group, Inc.
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Midland
country: United States
facility: MidMichigan Health Cancer Center
state: Michigan
city: Southfield
country: United States
facility: Providence Cancer Center
state: Michigan
city: Duluth
country: United States
facility: St. Luke's Speciality Clinic
state: Minnesota
city: Pascagoula
country: United States
facility: Singing River Health System
state: Mississippi
city: Elizabeth
country: United States
facility: Trinitas Comprehensive Cancer Center
state: New Jersey
city: Williamstown
country: United States
facility: Southern Oncology Hematology Associates
state: New Jersey
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates, P.C.
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Hematology Oncology Associates
state: New York
city: Rochester
country: United States
facility: Community Health Network
state: New York
city: Columbus
country: United States
facility: Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center
state: Ohio
city: Kettering
country: United States
facility: Dayton Physicians, LLC
state: Ohio
city: Corvallis
country: United States
facility: Good Samaritan Hospital Corvallis
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Bethlehem
country: United States
facility: Lehigh Valley Health network (Oncology)
state: Pennsylvania
city: Dunmore
country: United States
facility: Hematology and Oncology Associates of NEPA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Aria Health- Torresdale
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care
state: South Carolina
city: Bristol
country: United States
facility: Wellmont Blue Ridge Medical Specialists
state: Tennessee
city: Jacksonville
country: United States
facility: Jackson Madison County General Hospital
state: Tennessee
city: Arlington
country: United States
facility: Texas Oncology P A
state: Texas
city: Beaumont
country: United States
facility: Texas Oncology P A
state: Texas
city: Denton
country: United States
facility: Texas Oncology P A
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology P A
state: Texas
city: Houston
country: United States
facility: Texas Oncology-Memorial City
state: Texas
city: Paris
country: United States
facility: Texas Oncology P A
state: Texas
city: Plano
country: United States
facility: Texas Oncology P A
state: Texas
city: Tyler
country: United States
facility: Texas Oncology P A
state: Texas
city: Waco
country: United States
facility: Texas Oncology P A
state: Texas
city: Webster
country: United States
facility: Texas Oncology P A
state: Texas
city: Wichita Falls
country: United States
facility: Texas Oncology P A
state: Texas
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology & Oncology
state: Washington
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References: