Multiple Myeloma Clinical Trial
Official title:
Multiple Myeloma Patient Registry
| Verified date | August 2018 |
| Source | Janssen Scientific Affairs, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 85 |
| Est. completion date | April 6, 2018 |
| Est. primary completion date | April 6, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Abington Memorial Hospital | Abington | Pennsylvania |
| United States | Texas Oncology P A | Arlington | Texas |
| United States | Piedmont Cancer Institute | Atlanta | Georgia |
| United States | Augusta University | Augusta | Georgia |
| United States | Mercy Medical Center | Baltimore | Maryland |
| United States | Texas Oncology P A | Beaumont | Texas |
| United States | Lehigh Valley Health network (Oncology) | Bethlehem | Pennsylvania |
| United States | University Cancer Institute (UCI) | Boynton Beach | Florida |
| United States | Wellmont Blue Ridge Medical Specialists | Bristol | Tennessee |
| United States | Physicians' Clinic of Iowa, P.C at PCI Main Building | Cedar Rapids | Iowa |
| United States | Charleston Cancer Center | Charleston | South Carolina |
| United States | Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center | Columbus | Ohio |
| United States | Good Samaritan Hospital Corvallis | Corvallis | Oregon |
| United States | Pontchartrain Cancer Center | Covington | Louisiana |
| United States | Commonwealth Hematology-Oncology, P.C. | Danville | Kentucky |
| United States | Texas Oncology P A | Denton | Texas |
| United States | Rocky Mountain Cancer Centers | Denver | Colorado |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | St. Luke's Speciality Clinic | Duluth | Minnesota |
| United States | Hematology and Oncology Associates of NEPA | Dunmore | Pennsylvania |
| United States | North Shore Hematology Oncology Associates, P.C. | East Setauket | New York |
| United States | Trinitas Comprehensive Cancer Center | Elizabeth | New Jersey |
| United States | Hardin Memorial Hospital | Elizabethtown | Kentucky |
| United States | Texas Oncology P.A. | Flower Mound | Texas |
| United States | Southeast Florida Hematology Oncology Group | Fort Lauderdale | Florida |
| United States | Mercy Research | Fort Smith | Arkansas |
| United States | Meritus Center for Clinical Research | Hagerstown | Maryland |
| United States | Ingalls Memorial Hospital Cancer Research Center | Harvey | Illinois |
| United States | Kentucky Cancer Care | Hazard | Kentucky |
| United States | Genesis Cancer Center | Hot Springs | Arkansas |
| United States | Texas Oncology-Memorial City | Houston | Texas |
| United States | Cancer Specialists of North Florida | Jacksonville | Florida |
| United States | Jackson Madison County General Hospital | Jacksonville | Tennessee |
| United States | Mayo Clinic in Florida | Jacksonville | Florida |
| United States | St. Bernard's Medical Center | Jonesboro | Arkansas |
| United States | Kadlec Clinic Hematology & Oncology | Kennewick | Washington |
| United States | Dayton Physicians, LLC | Kettering | Ohio |
| United States | Watson Clinic Llp | Lakeland | Florida |
| United States | Gwinnett Hospital System, Inc | Lawrenceville | Georgia |
| United States | CARTI | Little Rock | Arkansas |
| United States | MidMichigan Health Cancer Center | Midland | Michigan |
| United States | Facey Medical Group | Mission Hills | California |
| United States | Baptist Healthcare Systems, Inc. d/b/a Baptist Health Floyd | New Albany | Indiana |
| United States | Tulane University Hospital & Clinics | New Orleans | Louisiana |
| United States | Ocala Oncology Center | Ocala | Florida |
| United States | North County Oncology | Oceanside | California |
| United States | Ventura County Hematology Oncology Specialists | Oxnard | California |
| United States | Oncology Associates of West Kentucky | Paducah | Kentucky |
| United States | West Kentucky Hematology-Oncology | Paducah | Kentucky |
| United States | Texas Oncology P.A. | Paris | Texas |
| United States | Singing River Health System | Pascagoula | Mississippi |
| United States | Aria Health- Torresdale | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | Arizona Oncology Associates, PC - HAL | Phoenix | Arizona |
| United States | Texas Oncology P A | Plano | Texas |
| United States | Hudson Valley Hematology Oncology Associates | Poughkeepsie | New York |
| United States | Community Health Network | Rochester | New York |
| United States | Carolina Blood and Cancer Care | Rock Hill | South Carolina |
| United States | Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs Candler Health System | Savannah | Georgia |
| United States | Orchard Healthcare Research | Skokie | Illinois |
| United States | Providence Cancer Center | Southfield | Michigan |
| United States | Texas Oncology P.A. | Tyler | Texas |
| United States | Texas Oncology P A | Waco | Texas |
| United States | Texas Oncology P.A. | Webster | Texas |
| United States | James R. Berenson, MD Inc. | West Hollywood | California |
| United States | PIH Health Hospital | Whittier | California |
| United States | Texas Oncology P.A. | Wichita Falls | Texas |
| United States | Southern Oncology Hematology Associates | Williamstown | New Jersey |
| United States | Reliant Medical Group, Inc. | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Janssen Scientific Affairs, LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |
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