Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NOPRODMMY4001 | Other Identifier | Janssen Scientific Affairs, LLC |
Not provided
Not provided
Not provided
Completion of study in orig timeframe not feasible considering evolving treatments for MM in US.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates, PC - HAL | Phoenix | Arizona | 85016 | United States | ||
| Mercy Research |
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided