Multiple Myeloma Patient Registry
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|ClinicalTrials.gov Identifier: NCT03180853|
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : April 6, 2018
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Multiple Myeloma Patient Registry|
|Actual Study Start Date :||June 30, 2017|
|Estimated Primary Completion Date :||April 21, 2022|
|Estimated Study Completion Date :||May 31, 2022|
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.
- Overall Response Rate [ Time Frame: 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.
- Time to Next Treatment (TTNT) [ Time Frame: 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.
- Overall Survival (OS) [ Time Frame: 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).
- Survival Time [ Time Frame: 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 [ Time Frame: 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 scale; higher score=better level of physical functioning.
- Katz Index of Independence for Activities of Daily Living [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180853
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
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|Study Director:||Janssen Scientific Affairs, LLC Clinical Trial||Janssen Scientific Affairs, LLC|