A 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 Proteasome Inhibitor (PI), Immunomodulatory Drug (IMID), and Cluster of Differentiation 38 (CD38) Monoclonal Antibody Treatment

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT04035226
• Lead Sponsor: Janssen-Cilag Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Study Start: 2019-08-02
• Primary Completion: 2022-10-27
• Study Completion: 2022-10-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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).
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.
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 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.
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.
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.
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.
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).
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.
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).
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.

Trial Locations

Locations (75)

Washington University School Of Medicine; 🇺🇸 Saint Louis, Missouri, United States

CHU de Montpellier Hopital Saint Eloi; 🇫🇷 Montpellier, France

Hopital Saint Louis; 🇫🇷 Paris cedex 10, France

CHU Poitiers - Hopital la Miletrie; 🇫🇷 Poitiers, France

Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany; 🇩🇪 Tubingen, Germany

Universitatsklinikum Wurzburg; 🇩🇪 Wuerzburg, Germany

Universita degli Studi di Padova Azienda Ospedaliera di Pa; 🇮🇹 Padova, Italy

Fondazione Policlinico Universitario A Gemelli IRCCS; 🇮🇹 Roma, Italy

Szpital Kliniczny im H Swiecickiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu; 🇵🇱 Poznan, Poland

Hosp Clinico Univ de Salamanca; 🇪🇸 Salamanca, Spain

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