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).
Study Type
OBSERVATIONAL
Enrollment
254
No intervention will be administered as a part of this study.
Oncology Institute of Hope and Innovation
Glendale, California, United States
Marin Cancer Center
Greenbrae, California, United States
Asclepes Research
Weeki Wachee, Florida, United States
Oncology Hematology Assoc of Central Illinois, P.C. d.b.a. Illinois CancerCare, P.C.
Peoria, Illinois, United States
Providence Cancer Center
Southfield, Michigan, United States
Overall Response Rate (ORR)
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.
Time frame: Up to 24 months
Very Good Partial Response (VGPR) Rate
VGPR rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.
Time frame: Up to 24 months
Complete Response (CR) Rate
CR rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.
Time frame: Up to 24 months
Stringent Complete Response (sCR) Rate
sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.
Time frame: Up to 24 months
Minimal Residual Disease (MRD) Negative Rate
Minimal residual disease (MRD) negative rate is defined as the percentage of patients with negative MRD status according to IMWG response criteria.
Time frame: Up to 24 months
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of patients with clinical benefit. CBR = ORR (sCR + CR + VGPR + PR) + minimal response (MR).
Time frame: Up to 24 months
Duration of Response
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 frame: Up to 24 months
Time to Response
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 frame: Up to 24 months
Time to Next Treatment [TTNT]
Time to next treatment is defined as the time from diagnosis to the start of the next-line treatment.
Time frame: Up to 24 months
Progression-free Survival (PFS)
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.
Time frame: Up to 24 months
Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death (PFS2)
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.
Time frame: Up to 24 months
Overall Survival (OS)
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.
Time frame: Up to 24 months
Change from Baseline in Health-related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Scale Score
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.
Time frame: Baseline up to 24 months
Change from Baseline in Health-related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer (EORTC) QLQ-MY20 Scale Score
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).
Time frame: Baseline up to 24 months
Change from Baseline in Health-related Quality of Life (HRQoL) using EQ-5D-5L Questionnaire Score
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).
Time frame: Baseline up to 24 months
Number of Patients with Adverse Events (AEs)
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.
Time frame: Up to 24 months
Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
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.
Time frame: Up to 24 months
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Washington University School Of Medicine
St Louis, Missouri, United States
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