A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma (MoMMent)

A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma

The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety of current standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.

Study Overview

• Status: Recruiting
• Conditions: Relapsed/Refractory Multiple Myeloma
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Completed
    • UZ Leuven
  • Yvoir, Belgium, 5530
    • Completed
    • Ucl de Mont-Godinne
• France
  • Lille, France, 59037
    • Active, not recruiting
    • CHRU de Lille - Hopital Claude Huriez
  • Montpellier Cedex 5, France, 34295
    • Active, not recruiting
    • CHU de Montpellier, Hopital Saint-Eloi
  • Nantes Cedex 1, France, 44093
    • Completed
    • CHU de Nantes hotel Dieu
  • Pierre-Bénite, France, 69495
    • Active, not recruiting
    • Centre hospitalier Lyon-Sud
  • Toulouse cedex 9, France, 31059
    • Active, not recruiting
    • Pôle IUC Oncopole CHU
• Germany
  • Berin, Germany, 12203
    • Recruiting
    • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • Dresden, Germany, 01307
    • Recruiting
    • Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden
  • Hamburg, Germany, 20251
    • Recruiting
    • Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik
  • Heidelberg, Germany, 69120
    • Recruiting
    • Universitaetsklinikum Heidelberg
  • Koeln, Germany, 50397
    • Recruiting
    • Universitaetsklinikum Koeln
  • Leipzig, Germany, 4103
    • Recruiting
    • Universitaetsklinikum Leipzig
  • Tubingen, Germany, 72076
    • Recruiting
    • Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
  • Wuerzburg, Germany, 97080
    • Recruiting
    • Universitatsklinikum Wurzburg
• Italy
  • Bari, Italy, 70124
    • Completed
    • U.O. Ematologia Istituto Tumori Giovanni Paolo II
  • Bologna, Italy, 40138
    • Active, not recruiting
    • Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
  • Catania, Italy, 95128
    • Active, not recruiting
    • Policlinico di Catania
  • Genova, Italy, 16132
    • Completed
    • IRCCS Azienda Ospedaliera San Martino - IST
  • Meldola, Italy, 47014
    • Active, not recruiting
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Padova, Italy, 35128
    • Active, not recruiting
    • Universita degli Studi di Padova Azienda Ospedaliera di Pa
  • Palermo, Italy, 90146
    • Active, not recruiting
    • Ospedale Villa Sofia-Cervello
  • Pavia, Italy, 27100
    • Active, not recruiting
    • Fondazione IRCCS Policlinico San Matteo
  • Roma, Italy, 00161
    • Completed
    • Università di Roma La Sapienza
  • Roma, Italy, 00168
    • Active, not recruiting
    • Fondazione Policlinico Universitario A Gemelli IRCCS
  • San Giovanni Rotondo, Italy, 71013
    • Completed
    • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Tricase, Italy, 73039
    • Completed
    • Ospedale Cardinale G. Panico
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Completed
    • VU Medisch Centrum
  • Groningen, Netherlands, 9713 GZ
    • Active, not recruiting
    • UMCG
• Spain
  • Barcelona, Spain, 08908
    • Completed
    • Inst. Cat. Doncologia-H Duran I Reynals
  • Gijón, Spain, 33394
    • Active, not recruiting
    • Hosp. de Cabuenes
  • Jerez de la Frontera, Spain, 11407
    • Completed
    • Hosp. de Jerez de La Frontera
  • Leon, Spain, 24008
    • Completed
    • Hosp. de Leon
  • Madrid, Spain, 28034
    • Completed
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28041
    • Completed
    • Hosp. Univ. 12 de Octubre
  • Palma, Spain, 7120
    • Active, not recruiting
    • Hosp. Univ. Son Espases
  • Pamplona, Spain, 31008
    • Completed
    • Clinica Univ. de Navarra
  • Salamanca, Spain, 37007
    • Completed
    • Hosp. Clinico Univ. de Salamanca
  • Santander, Spain, 39008
    • Completed
    • Hosp. Univ. Marques de Valdecilla
  • Santiago de Compostela, Spain, 15706
    • Completed
    • Hosp. Clinico Univ. de Santiago
  • Valladolid, Spain, 47003
    • Completed
    • Hosp. Clinico Univ. de Valladolid
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • Active, not recruiting
    • Southmead Hospital
  • London, United Kingdom, NW1 2PG
    • Completed
    • University College Hospital
  • London, United Kingdom, SW17 OQT
    • Completed
    • St George's Hospital
  • London, United Kingdom, SE5 9RS
    • Completed
    • King s College Hospital
  • Maidstone, United Kingdom, ME16 9QQ
    • Completed
    • Maidstone Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Active, not recruiting
    • Nottingham University Hospitals NHS Trust
  • Surrey, United Kingdom, SM2 5PT
    • Completed
    • The Royal Marsden NHS Trust Sutton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of participants with previously treated multiple myeloma, having received standard of care (SOC) antimyeloma treatments during local clinical practices.

Description

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 (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the line of therapy
• 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
• Must have documented evidence of progressive disease based on participating physician's determination of response by the IMWG response criteria on or after the last regimen. Participants with documented evidence of progressive disease within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are also eligible

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with Relapsed/Refractory Multiple Myeloma; Participants with relapsed/refractory multiple myeloma (RRMM) receiving antimyeloma treatment as standard of care (SOC) under routine clinical practice will be observed. The primary data source will be medical records of each participant.	Other: No intervention; There is no interventional treatment component for participants with RRMM in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC).	Up to 35 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Very Good Partial Response (VGPR) Rate	VGPR rate is defined as the percentage of participants who achieve a VGPR or better response according to IMWG response criteria.	Up to 35 months
Complete Response (CR) Rate	CR rate is defined as the percentage of participants who achieve a CR or better response according to IMWG response criteria.	Up to 35 months
Stringent Complete Response (sCR) Rate	sCR rate is defined as the percentage of participants who achieve a sCR according to IMWG response criteria.	Up to 35 months
Minimal Residual Disease (MRD) Negative Rate	MRD negative rate is defined as the percentage of participants with negative MRD status according to IMWG response criteria.	Up to 35 months
Clinical Benefit Rate (CBR)	CBR is defined as the percentage of participants with clinical benefit. CBR=ORR (sCR + CR + VGPR + PR) + minimal response (MR).	Up to 35 months
Duration of Response (DOR)	DOR 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 as defined in the IMWG criteria.	Up to 35 months
Time to Response (TTR)	TTR is defined as the time between the date of Day 1 of Cycle 1 and the first clinical response evaluation that the participant has met all criteria for PR or better response.	Up to 35 months
Time to Best Response	Time to best response is defined as the time between the date of Day 1 of Cycle 1 and best objective response.	Up to 35 months
Time to Next Treatment (TTNT)	TTNT is defined as the time from diagnosis to the start of the next-line treatment.	Up to 35 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 (as defined in the IMWG response criteria) or death due to any cause, whichever occurs first.	Up to 35 months
Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (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.	Up to 35 months
Overall Survival (OS)	OS is the duration from the date of Day 1 of Cycle 1 to the date of the participant's death or study completion, whichever occurs first.	Up to 35 months
Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score	The EORTC-QLQ-C30 Version 3 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.	Baseline up to 35 months
Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)	The EQ-5D-5L is a generic measure of health status. The 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).	Baseline up to 35 months
Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EORTC QLQ-IL39	EORTC QLQ-IL39 (four single items from the EORTC QLQMY20) 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).	Baseline up to 35 months
Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 35 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.	Up to 35 months

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutica N.V., Belgium
• Investigators: Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial, Janssen Pharmaceutica N.V., Belgium

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Estimated): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: CR109118; 64407564MMY4001 (Other Identifier: Janssen Pharmaceutica N.V., Belgium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No