Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to assess the safety and clinical response including overall response rate (ORR) of real-life standard-of-care (SOC) treatments under routine clinical practice, over a 24-month period, in patients with relapsed/refractory multiple myeloma (RRMM).
Interventions
OTHERNo intervention
No intervention will be administered as a part of this study.
Sponsors
Legend Biotech
Janssen-Cilag Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria * Received at least 3 prior lines of therapy or are double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMID) (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Patients will have undergone at least 1 complete cycle of treatment for each regimen (unless progressive disease was the best response) * Must have documented evidence of progressive disease based on study physician's determination of response by the IMWG response criteria on or after the last regimen. Patients with documented evidence of progressive disease within the previous 6 months and who are refractory or nonresponsive to their most recent line of treatment afterwards are also eligible * Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1 * Must not be pregnant or must not plan to become pregnant within the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to 24 months | ORR is defined as the percentage of patients who achieve a partial response (PR) or better according to the international myeloma working group (IMWG) response criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response (CR) Rate | Up to 24 months | CR rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria. |
| Stringent Complete Response (sCR) Rate | Up to 24 months | sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria. |
| Minimal Residual Disease (MRD) Negative Rate | Up to 24 months | Minimal residual disease (MRD) negative rate is defined as the percentage of patients with negative MRD status according to IMWG response criteria. |
| Clinical Benefit Rate (CBR) | Up to 24 months | CBR is defined as the percentage of patients with clinical benefit. CBR = ORR (sCR + CR + VGPR + PR) + minimal response (MR). |
| Duration of Response | Up to 24 months | Duration of response is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease (according to IMWG criteria). |
| Time to Response | Up to 24 months | Time to response is defined as the time between the date of Day 1 of Cycle 1 and the first clinical response evaluation that the patient has met all criteria for PR or better response. |
| Time to Next Treatment [TTNT] | Up to 24 months | Time to next treatment is defined as the time from diagnosis to the start of the next-line treatment. |
| Very Good Partial Response (VGPR) Rate | Up to 24 months | VGPR rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria. |
| Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death (PFS2) | Up to 24 months | PFS2 is defined as the time from the date of Day 1 of Cycle 1 to progression on the next line of subsequent antimyeloma therapy or death, whichever occurs first. |
| Overall Survival (OS) | Up to 24 months | Overall survival is the duration from the date of Day 1 of Cycle 1 to the date of the patient's death or study completion, whichever occurs first. |
| Change from Baseline in Health-related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Scale Score | Baseline up to 24 months | The EORTC QLQ-C30 version 3 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater health-related quality-of-life (HRQoL), better functioning, and more (worse) symptoms. |
| Change from Baseline in Health-related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer (EORTC) QLQ-MY20 Scale Score | Baseline up to 24 months | The EORTC QLQ-MY20 was designed to use alongside the EORTC QLQ-C30 to address issues of more relevance to myeloma patients. Four single items from the EORTC QLQ-MY20 will be performed to assess emotional health status (feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future) on scale of 1 (not at all) to 4 (very much). |
| Change from Baseline in Health-related Quality of Life (HRQoL) using EQ-5D-5L Questionnaire Score | Baseline up to 24 months | EuroQol Five Dimension (EQ-5D-5L) is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Number of Patients with Adverse Events (AEs) | Up to 24 months | An AE is any untoward medical occurrence in a patient participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
| Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) | Up to 24 months | Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death related to adverse event. |
| Progression-free Survival (PFS) | Up to 24 months | PFS is defined as the time from the date of Day 1 of Cycle 1 to the date of first documented disease progression (according to IMWG response criteria) or death due to any cause, whichever occurs first. |
Countries
Belgium, France, Germany, Italy, Netherlands, Poland, Russia, Spain, United Kingdom, United States
Outcome results
None listed