Study Stopped
Completion of study in orig timeframe not feasible considering evolving treatments for MM in US.
Completion of study in orig timeframe not feasible considering evolving treatments for MM in US.
Sponsor study identifier
Secondary identifiers
OTHER · Janssen Scientific Affairs, LLC
observational
85
1 country
69
Study Start
May 8, 2017
Actual (reported)Primary Completion
April 6, 2018
Actual (reported)Study Completion
April 6, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 6, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 8, 2017
Actual (reported)June 6, 2017
Actual (reported)June 8, 2017
Actual (reported)April 6, 2018
Actual (reported)April 6, 2018
Actual (reported)Overall Response Rate
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.
Up to 3 years
Time to Next Treatment (TTNT)
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.
Up to 3 years
Overall Survival (OS)
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).
Up to 3 years
Survival Time
Survival time is defined as the time from the start of each respective treatment to death (or last documented follow-up).
Up to 3 years
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
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 scale; higher score=better level of physical functioning.
Up to 3 years
Katz Index of Independence for Activities of Daily Living
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.
Up to 3 years
Lawton Instrumental Activities of Daily Living
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.
Up to 3 years
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.
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.
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, 85016, United States
Mercy Research
Fort Smith, Arkansas, 72903-4100, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
St. Bernard's Medical Center
Jonesboro, Arkansas, 72401, United States
CARTI
Little Rock, Arkansas, 72205, United States
Facey Medical Group
Mission Hills, California, 91345, United States
North County Oncology
Oceanside, California, 92056, United States
Janssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC
85 participants (actual enrollment reported by the registry).
First Submitted
June 6, 2017
First Posted
June 8, 2017
Study Start
May 8, 2017
Actual (reported)Combination Study for High Risk Multiple Myeloma Patients
Contact the study team to confirm eligibility.
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030, United States
James R. Berenson, MD Inc.
West Hollywood, California, 90069, United States
PIH Health Hospital
Whittier, California, 90602, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
University Cancer Institute (UCI)
Boynton Beach, Florida, 33426, United States
Southeast Florida Hematology Oncology Group
Fort Lauderdale, Florida, 33308, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
Watson Clinic Llp
Lakeland, Florida, 33805, United States
Ocala Oncology Center
Ocala, Florida, 34471, United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318, United States
Augusta University
Augusta, Georgia, 30912, United States
Gwinnett Hospital System, Inc
Lawrenceville, Georgia, 30046, United States
Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs Candler Health System
Savannah, Georgia, 31405, United States
Ingalls Memorial Hospital Cancer Research Center
Harvey, Illinois, 60426, United States
Orchard Healthcare Research
Skokie, Illinois, 60077, United States
Baptist Healthcare Systems, Inc. d/b/a Baptist Health Floyd
New Albany, Indiana, 47150, United States
Physicians' Clinic of Iowa, P.C at PCI Main Building
Cedar Rapids, Iowa, 52403, United States
Commonwealth Hematology-Oncology, P.C.
Danville, Kentucky, 40422, United States
Hardin Memorial Hospital
Elizabethtown, Kentucky, 42701, United States
Kentucky Cancer Care
Hazard, Kentucky, 41701, United States
Oncology Associates of West Kentucky
Paducah, Kentucky, 42003, United States
West Kentucky Hematology-Oncology
Paducah, Kentucky, 42003, United States
Pontchartrain Cancer Center
Covington, Louisiana, 70433, United States
Tulane University Hospital & Clinics
New Orleans, Louisiana, 70112, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742, United States
Reliant Medical Group, Inc.
Worcester, Massachusetts, 01608, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
MidMichigan Health Cancer Center
Midland, Michigan, 48640, United States
Providence Cancer Center
Southfield, Michigan, 48075, United States
St. Luke's Speciality Clinic
Duluth, Minnesota, 55802, United States
Singing River Health System
Pascagoula, Mississippi, 39581, United States
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, 07207, United States
Southern Oncology Hematology Associates
Williamstown, New Jersey, 08360, United States
North Shore Hematology Oncology Associates, P.C.
East Setauket, New York, 11733, United States
Hudson Valley Hematology Oncology Associates
Poughkeepsie, New York, 12601, United States
Community Health Network
Rochester, New York, 14620, United States
Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center
Columbus, Ohio, 43219, United States
Dayton Physicians, LLC
Kettering, Ohio, 45409, United States
Good Samaritan Hospital Corvallis
Corvallis, Oregon, 97330, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Lehigh Valley Health network (Oncology)
Bethlehem, Pennsylvania, 18015, United States
Hematology and Oncology Associates of NEPA
Dunmore, Pennsylvania, 18512, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Aria Health- Torresdale
Philadelphia, Pennsylvania, 19114, United States
Charleston Cancer Center
Charleston, South Carolina, 29406, United States
Carolina Blood and Cancer Care
Rock Hill, South Carolina, 29732, United States
Wellmont Blue Ridge Medical Specialists
Bristol, Tennessee, 37620, United States
Jackson Madison County General Hospital
Jacksonville, Tennessee, 38301, United States
Texas Oncology P A
Arlington, Texas, 76012, United States
Texas Oncology P A
Beaumont, Texas, 77702-1449, United States
Texas Oncology P A
Denton, Texas, 76210, United States
Texas Oncology P A
Flower Mound, Texas, 75028, United States
Texas Oncology-Memorial City
Houston, Texas, 77024, United States
Texas Oncology P A
Paris, Texas, 75460, United States
Texas Oncology P A
Plano, Texas, 75075, United States
Texas Oncology P A
Tyler, Texas, 75702, United States
Texas Oncology P A
Waco, Texas, 76712, United States
Texas Oncology P A
Webster, Texas, 77598, United States
Texas Oncology P A
Wichita Falls, Texas, 76310, United States
Kadlec Clinic Hematology & Oncology
Kennewick, Washington, 99336, United States
Primary Completion
April 6, 2018
Actual (reported)Study Completion
April 6, 2018
Actual (reported)Last Updated
February 3, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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