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)

March 28, 2025 updated by: Janssen-Cilag Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
254

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Hôpital Saint-Antoine
      • Paris cedex 10, France, 75475
        • Hopital 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
      • Tubingen, Germany, 72076
        • Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
      • Wuerzburg, 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, 00161
        • Università di Roma La Sapienza
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario A Gemelli IRCCS
      • 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
        • Kings 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
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.
Up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Very Good Partial Response (VGPR) Rate
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.
Up to 24 months
Complete Response (CR) Rate
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.
Up to 24 months
Stringent Complete Response (sCR) Rate
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.
Up to 24 months
Minimal Residual Disease (MRD) Negative Rate
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.
Up to 24 months
Clinical Benefit Rate (CBR)
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).
Up to 24 months
Duration of Response
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).
Up to 24 months
Time to Response
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.
Up to 24 months
Time to Next Treatment [TTNT]
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.
Up to 24 months
Progression-free Survival (PFS)
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.
Up to 24 months
Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death (PFS2)
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.
Up to 24 months
Overall Survival (OS)
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.
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
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.
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
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).
Baseline up to 24 months
Change from Baseline in Health-related Quality of Life (HRQoL) using EQ-5D-5L Questionnaire Score
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).
Baseline up to 24 months
Number of Patients with Adverse Events (AEs)
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.
Up to 24 months
Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
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.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Legend Biotech

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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