No intervention
OtherNo intervention will be administered as a part of this study.
NCT Number: NCT04035226
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).
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Notify Me18 year and older
All sexes
Observational
Grand Hopital de Charleroi, site Notre Dame, Charleroi, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
No intervention will be administered as a part of this study.
Time frame: 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.
Time frame: 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 frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 months
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 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 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 is defined as the time from diagnosis to the start of the next-line treatment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Janssen-Cilag Ltd.
Industry
A Prospective, Multinational Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including PI, IMID, and CD38 Monoclonal Antibody Treatment
Acronym: LocoMMotion
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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