Multiple Myeloma Patient Registry
- Conditions
- Multiple Myeloma
- Registration Number
- NCT03180853
- Lead Sponsor
- Janssen Scientific Affairs, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 85
- 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)
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival Time Up to 3 years Survival time is defined as the time from the start of each respective treatment to death (or last documented follow-up).
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score Up to 3 years EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants. It is composed of 30 items, multiitem measure (28 items) and 2 single-item measures. For the multiple item measure, 4 point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7 point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening. Scores are averaged, and transformed to 0-100 scaleอพ higher score=better level of physical functioning.
Overall Response Rate Up to 3 years Overall response rate defined as the percentage of participants achieving Complete Response (CR), Very good partial response (VGPR), or Partial response (PR) (CR + VGPR + PR) as per International Myeloma Working Group (IMWG 2016) criteria. CR as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and less than(\<) 5 percent (%) plasma cells in bone marrow(BM). VGPR as serum and urine M-protein (monoclonal paraprotein) detectable by immunofixation but not on electrophoresis or 90% or greater than (\>) reduction in serum and urine M-protein level \<100 milligram (mg) per 24 hour (hr). PR as greater than or equal to (\>=) 50% reduction of serum M-protein and less than (\>=) 90% of urine M-protein or up to \<200 mg per 24 hour.
Overall Survival (OS) Up to 3 years OS is defined as the time from the date of initiation of therapy to the date of death from any cause (or last documented follow-up).
Time to Next Treatment (TTNT) Up to 3 years TTNT is defined as the time from the date of initiation of regimen for induction to the initiation of next regimen for each successive therapy received.
Katz Index of Independence for Activities of Daily Living Up to 3 years A standardized, validated tool that asks about independence in bathing, dressing, toileting, transferring, continence and feeding. The index having values from A to G. A indicates independence in all six functions and G indicates dependence in all six Functions.
Lawton Instrumental Activities of Daily Living Up to 3 years This questionnaire measures participants' abilities to do instrumental activities of daily living such as ability to use telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibilities of own medication and managing finances. The scale ranges from 0 to 8, a lower scale indicates higher level of dependence.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (60)
Arizona Oncology Associates, PC - HAL
๐บ๐ธPhoenix, Arizona, United States
Mercy Research
๐บ๐ธFort Smith, Arkansas, United States
Genesis Cancer Center
๐บ๐ธHot Springs, Arkansas, United States
St. Bernard's Medical Center
๐บ๐ธJonesboro, Arkansas, United States
CARTI
๐บ๐ธLittle Rock, Arkansas, United States
Facey Medical Group
๐บ๐ธMission Hills, California, United States
North County Oncology
๐บ๐ธOceanside, California, United States
Ventura County Hematology Oncology Specialists
๐บ๐ธOxnard, California, United States
James R. Berenson, MD Inc.
๐บ๐ธWest Hollywood, California, United States
PIH Health Hospital
๐บ๐ธWhittier, California, United States
Rocky Mountain Cancer Centers
๐บ๐ธDenver, Colorado, United States
University Cancer Institute (UCI)
๐บ๐ธBoynton Beach, Florida, United States
Southeast Florida Hematology Oncology Group
๐บ๐ธFort Lauderdale, Florida, United States
Mayo Clinic in Florida
๐บ๐ธJacksonville, Florida, United States
Cancer Specialists of North Florida
๐บ๐ธJacksonville, Florida, United States
Watson Clinic Llp
๐บ๐ธLakeland, Florida, United States
Ocala Oncology Center
๐บ๐ธOcala, Florida, United States
Piedmont Cancer Institute
๐บ๐ธAtlanta, Georgia, United States
Augusta University
๐บ๐ธAugusta, Georgia, United States
Gwinnett Hospital System, Inc
๐บ๐ธLawrenceville, Georgia, United States
Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs Candler Health System
๐บ๐ธSavannah, Georgia, United States
Ingalls Memorial Hospital Cancer Research Center
๐บ๐ธHarvey, Illinois, United States
Orchard Healthcare Research
๐บ๐ธSkokie, Illinois, United States
Baptist Healthcare Systems, Inc. d/b/a Baptist Health Floyd
๐บ๐ธNew Albany, Indiana, United States
Physicians' Clinic of Iowa, P.C at PCI Main Building
๐บ๐ธCedar Rapids, Iowa, United States
Commonwealth Hematology-Oncology, P.C.
๐บ๐ธDanville, Kentucky, United States
Hardin Memorial Hospital
๐บ๐ธElizabethtown, Kentucky, United States
Kentucky Cancer Care
๐บ๐ธHazard, Kentucky, United States
Oncology Associates of West Kentucky
๐บ๐ธPaducah, Kentucky, United States
West Kentucky Hematology-Oncology
๐บ๐ธPaducah, Kentucky, United States
Pontchartrain Cancer Center
๐บ๐ธCovington, Louisiana, United States
Tulane University Hospital & Clinics
๐บ๐ธNew Orleans, Louisiana, United States
Mercy Medical Center
๐บ๐ธBaltimore, Maryland, United States
Meritus Center for Clinical Research
๐บ๐ธHagerstown, Maryland, United States
Reliant Medical Group, Inc.
๐บ๐ธWorcester, Massachusetts, United States
Henry Ford Health System
๐บ๐ธDetroit, Michigan, United States
MidMichigan Health Cancer Center
๐บ๐ธMidland, Michigan, United States
Providence Cancer Center
๐บ๐ธSouthfield, Michigan, United States
St. Luke's Speciality Clinic
๐บ๐ธDuluth, Minnesota, United States
Singing River Health System
๐บ๐ธPascagoula, Mississippi, United States
Trinitas Comprehensive Cancer Center
๐บ๐ธElizabeth, New Jersey, United States
Southern Oncology Hematology Associates
๐บ๐ธWilliamstown, New Jersey, United States
North Shore Hematology Oncology Associates, P.C.
๐บ๐ธEast Setauket, New York, United States
Hudson Valley Hematology Oncology Associates
๐บ๐ธPoughkeepsie, New York, United States
Community Health Network
๐บ๐ธRochester, New York, United States
Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center
๐บ๐ธColumbus, Ohio, United States
Dayton Physicians, LLC
๐บ๐ธKettering, Ohio, United States
Good Samaritan Hospital Corvallis
๐บ๐ธCorvallis, Oregon, United States
Abington Memorial Hospital
๐บ๐ธAbington, Pennsylvania, United States
Lehigh Valley Health network (Oncology)
๐บ๐ธBethlehem, Pennsylvania, United States
Hematology and Oncology Associates of NEPA
๐บ๐ธDunmore, Pennsylvania, United States
Thomas Jefferson University Hospital
๐บ๐ธPhiladelphia, Pennsylvania, United States
Aria Health- Torresdale
๐บ๐ธPhiladelphia, Pennsylvania, United States
Charleston Cancer Center
๐บ๐ธCharleston, South Carolina, United States
Carolina Blood and Cancer Care
๐บ๐ธRock Hill, South Carolina, United States
Wellmont Blue Ridge Medical Specialists
๐บ๐ธBristol, Tennessee, United States
Jackson Madison County General Hospital
๐บ๐ธJacksonville, Tennessee, United States
Texas Oncology P A
๐บ๐ธWichita Falls, Texas, United States
Texas Oncology-Memorial City
๐บ๐ธHouston, Texas, United States
Kadlec Clinic Hematology & Oncology
๐บ๐ธKennewick, Washington, United States