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 (LocoMMotion)

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

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 Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 254

Contacts and Locations

Study Locations

• Belgium
  • Charleroi, Belgium, 6000
    • Grand Hopital de Charleroi, site Notre Dame
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Yvoir, Belgium, 5530
    • Ucl de Mont-Godinne
• France
  • Le Mans, France, 72000
    • Centre Hospitalier Du Mans
  • Lille Cedex, France, 59000
    • Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
  • Montpellier, France, 34295
    • CHU de Montpellier, Hopital Saint-Eloi
  • Nantes, France, 44093
    • C.H.U. Hotel Dieu - France
  • PARIS cedex 12, France, 75571
    • Hopital Saint-Antoine
  • Paris cedex 10, France, 75475
    • Hôpital Saint-Louis
  • Pierre-Bénite, France, 69495
    • Centre hospitalier Lyon-Sud
  • Poitiers, France, 86021
    • CHU Poitiers - Hôpital la Milétrie
  • Toulouse cedex 9, France, 31059
    • Pôle IUC Oncopole CHU
• Germany
  • Hamburg, Germany, 20251
    • Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Koeln, Germany, 50397
    • Universitaetsklinikum Koelnt
  • Muenster, Germany, 48149
    • Medizinische Klinik A
  • Tübingen, Germany, 72076
    • Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg
• Italy
  • Bari, Italy, 70124
    • U.O. Ematologia con Trapianto- AOU Policlinico di Bari
  • Bari, Italy, 70124
    • U.O. Ematologia Istituto Tumori Giovanni Paolo II
  • Bologna, Italy, 40138
    • Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
  • Catania, Italy, 95128
    • Policlinico di Catania
  • Firenze, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi
  • Genova, Italy, 16132
    • IRCCS Azienda Ospedaliera San Martino - IST
  • Meldola, Italy, 47014
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Padova, Italy, 35128
    • Universita degli Studi di Padova - Azienda Ospedaliera di Pa
  • Palermo, Italy, 90146
    • Ospedale Villa Sofia-Cervello
  • Pavia, Italy, 27100
    • Fondazione Irccs Policlinico San Matteo
  • Rionero in Vulture, Italy, 85028
    • Irccs Crob
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
  • Roma, Italy, 00161
    • Università di Roma La Sapienza
  • San Giovanni Rotondo, Italy, 71013
    • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Tricase, Italy, 73039
    • Ospedale Cardinale G. Panico
  • Turin, Italy, 10126
    • A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU Medisch Centrum
  • Groningen, Netherlands, 9713 GZ
    • UMCG
  • Rotterdam, Netherlands, 3075 EA
    • Erasmus MC - Satellite
• Poland
  • Lublin, Poland, 20-081
    • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
  • Poznan, Poland, 60-569
    • Szpital Kliniczny im. H. Swiecickiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu
• Russian Federation
  • Moscow, Russian Federation, 125284
    • S.P. Botkin Moscow City Clinical Hospital
  • Samara, Russian Federation, 443095
    • Samara Region Clinical Hospital
  • St-Petersburg, Russian Federation, 191024
    • Clinical Research Institute of Hematology and Transfusiology
• Spain
  • Barcelona, Spain, 08908
    • Inst. Cat. Doncologia-H Duran I Reynals
  • Cadiz, Spain, 11009
    • Hosp. Puerta Del Mar
  • Jerez de la Frontera, Spain, 11407
    • Hosp. de Jerez de La Frontera
  • Leon, Spain, 24008
    • Hosp. de Leon
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28034
    • Hosp. Univ. Ramon Y Cajal
  • Palma, Spain, 7120
    • Hosp. Univ. Son Espases
  • Pamplona, Spain, 31008
    • Clinica Univ. de Navarra
  • Salamanca, Spain, 37007
    • Hosp. Clinico Univ. de Salamanca
  • Santander, Spain, 39008
    • Hosp. Univ. Marques de Valdecilla
  • Terrassa, Spain, 08221
    • Hosp. Mutua Terrassa
  • Valencia, Spain, 46017
    • Hosp. Univ. Dr. Peset
  • Valladolid, Spain, 47003
    • Hosp. Clinico Univ. de Valladolid
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Birmingham Heartlands Hospital
  • Bristol, United Kingdom, BS10 5NB
    • Southmead Hospital
  • Kent, United Kingdom, ME16 9QQ
    • Maidstone Hospital
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, SW17 OQT
    • St George's Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham University Hospitals Nhs Trust
  • Surrey, United Kingdom, SM2 5PT
    • The Royal Marsden NHS Trust Sutton
• United States
  • California
    • Glendale, California, United States, 91204
      • Oncology Institute of Hope and Innovation
    • Greenbrae, California, United States, 94904
      • Marin Cancer Center
  • Florida
    • Weeki Wachee, Florida, United States, 34607
      • Asclepes Research
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Oncology Hematology Assoc of Central Illinois, P.C. d.b.a. Illinois CancerCare, P.C.
  • Michigan
    • Southfield, Michigan, United States, 48075
      • Providence Cancer Center
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • Central Care Cancer Center
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Optum Care
  • New Jersey
    • Flemington, New Jersey, United States, 08822
      • Hunterdon Hematology Oncology
  • New York
    • East Hills, New York, United States, 11548
      • The Cancer Institute at St. Francis Hospital
    • East Setauket, New York, United States, 11733
      • North Shore Hematology Oncology Associates, P.C.
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

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

Patients with relapsed/refractory multiple myeloma (RRMM) receiving antimyeloma treatment as standard of care (SOC) under routine clinical practice will be observed. The main source of data collection will be medical records of each patient.

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 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

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
Relapsed/refractory Multiple Myeloma; Patients with relapsed/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 will be observed.	Other: No intervention; No intervention will be administered as a part of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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).	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).	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.	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.	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.	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.	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.	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.	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).	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).	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.	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.	Up to 24 months

Collaborators and Investigators

• Sponsor: Janssen-Cilag Ltd.
• Collaborators: Legend Biotech
• Investigators: Study Director: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.

Publications and helpful links

General Publications

• Mateos MV, Weisel K, De Stefano V, Goldschmidt H, Delforge M, Mohty M, Cavo M, Vij R, Lindsey-Hill J, Dytfeld D, Angelucci E, Perrot A, Benjamin R, van de Donk NWCJ, Ocio EM, Scheid C, Gay F, Roeloffzen W, Rodriguez-Otero P, Broijl A, Potamianou A, Sakabedoyan C, Semerjian M, Keim S, Strulev V, Schecter JM, Vogel M, Wapenaar R, Nesheiwat T, San-Miguel J, Sonneveld P, Einsele H, Moreau P. LocoMMotion: a prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed and/or refractory multiple myeloma. Leukemia. 2022 May;36(5):1371-1376. doi: 10.1038/s41375-022-01531-2. Epub 2022 Mar 24.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2019
• Primary Completion (Actual): October 27, 2022
• Study Completion (Actual): October 27, 2022

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

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: CR108651; 68284528MMY4001 (Other Identifier: Janssen-Cilag Ltd.)

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 device product: No