LocoMMotion: 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

Sponsor
Janssen-Cilag Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04035226
Collaborator
Legend Biotech (Other)
261
Enrollment
86
Locations
38.8
Anticipated Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or DiseaseIntervention/TreatmentPhase
  • Other: No intervention

Study Design

Study Type:
Observational
Actual Enrollment :
261 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Aug 2, 2019
Anticipated Primary Completion Date :
Apr 28, 2022
Anticipated Study Completion Date :
Oct 27, 2022

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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).

  14. 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).

  15. 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.

  16. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Oncology Institute of Hope and InnovationTucsonArizonaUnited States85745
2Oncology Institute of Hope and InnovationCoronaCaliforniaUnited States92882
3Oncology Institute of Hope and InnovationGlendaleCaliforniaUnited States91204
4Marin Cancer CenterGreenbraeCaliforniaUnited States94904
5Asclepes ResearchWeeki WacheeFloridaUnited States34607
6Oncology Hematology Assoc of Central Illinois, P.C. d.b.a. Illinois CancerCare, P.C.PeoriaIllinoisUnited States61615
7Providence Cancer CenterSouthfieldMichiganUnited States48075
8Central Care Cancer CenterBolivarMissouriUnited States65613
9Washington University School of MedicineSaint LouisMissouriUnited States63110
10Optum CareLas VegasNevadaUnited States89102
11Hunterdon Hematology OncologyFlemingtonNew JerseyUnited States08822
12The Cancer Institute at St. Francis HospitalEast HillsNew YorkUnited States11548
13North Shore Hematology Oncology Associates, P.C.East SetauketNew YorkUnited States11733
14The Ohio State UniversityColumbusOhioUnited States43210
15Grand Hôpital de Charleroi, site Notre DameCharleroiBelgium6000
16Universitair Ziekenhuis AntwerpenEdegemBelgium2650
17UZ LeuvenLeuvenBelgium3000
18Ucl de Mont-GodinneYvoirBelgium5530
19Centre Hospitalier du MansLe MansFrance72000
20Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude HuriezLille CedexFrance59000
21CHU de Montpellier, Hopital Saint-EloiMontpellierFrance34295
22C.H.U. Hotel Dieu - FranceNantesFrance44093
23Hopital Saint-LouisParis cedex 10France75475
24Hopital Saint-AntoinePARIS cedex 12France75571
25CHU de Bordeaux - Hôpital Haut-LévêquePessac cedexFrance33604
26Centre hospitalier Lyon-SudPierre-BéniteFrance69495
27CHU Poitiers - Hôpital la MilétriePoitiersFrance86021
28Pôle IUC Oncopole CHUToulouse cedex 9France31059
29Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und PoliklinikHamburgGermany20251
30Universitaetsklinikum HeidelbergHeidelbergGermany69120
31Universitaetsklinikum KoelnKoelnGermany50397
32Medizinische Klinik AMuensterGermany48149
33Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-GermanyTübingenGermany72076
34Universitätsklinikum WürzburgWürzburgGermany97080
35U.O. Ematologia con Trapianto- AOU Policlinico di BariBariItaly70124
36U.O. Ematologia Istituto Tumori Giovanni Paolo IIBariItaly70124
37Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-MalpighiBolognaItaly40138
38Policlinico di CataniaCataniaItaly95128
39Azienda Ospedaliera Universitaria CareggiFirenzeItaly50134
40IRCCS Azienda Ospedaliera San Martino - ISTGenovaItaly16132
41Istituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriMeldolaItaly47014
42Universita degli Studi di Padova - Azienda Ospedaliera di PaPadovaItaly35128
43Ospedale Villa Sofia-CervelloPalermoItaly90146
44Fondazione IRCCS Policlinico San MatteoPaviaItaly27100
45Irccs CrobRionero in VultureItaly85028
46Università di Roma La SapienzaRomaItaly00161
47Fondazione Policlinico Universitario A. Gemelli IRCCSRomeItaly00168
48IRCCS Ospedale Casa Sollievo della SofferenzaSan Giovanni RotondoItaly71013
49Ospedale Cardinale G. PanicoTricaseItaly73039
50A.O.U. Citta della Salute e della Scienza di Torino - Presidio MolinetteTurinItaly10126
51VU Medisch CentrumAmsterdamNetherlands1081 HV
52UMCGGroningenNetherlands9713 GZ
53Erasmus MC - SatelliteRotterdamNetherlands3075 EA
54Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali MiejskichChorzówPoland41-500
55Samodzielny Publiczny Szpital Kliniczny nr 1 w LublinieLublinPoland20-081
56Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola MarcinkowskiegoPoznanPoland60-569
57S.P. Botkin Moscow City Clinical HospitalMoscowRussian Federation125284
58City Clinical Hospital # 40MoscowRussian Federation129301
59Nizhniy Novgorod Region Clinical HospitalNizhny NovgorodRussian Federation603126
60Samara Region Clinical HospitalSamaraRussian Federation443095
61Clinical Research Institute of Hematology and TransfusiologySt-PetersburgRussian Federation191024
62Hosp. Clinic I Provincial de BarcelonaBarcelonaSpain08036
63Inst. Cat. Doncologia-H Duran I ReynalsBarcelonaSpain08908
64Hosp. Puerta Del MarCadizSpain11009
65Hosp. de Jerez de La FronteraJerez de la FronteraSpain11407
66Hosp. de LeonLeonSpain24080
67Hosp. Univ. Ramon Y CajalMadridSpain28034
68Hosp. Univ. 12 de OctubreMadridSpain28041
69Hosp. Univ. Son EspasesPalmaSpain7120
70Clinica Univ. de NavarraPamplonaSpain31008
71Hosp. Clinico Univ. de SalamancaSalamancaSpain37007
72Hosp. Univ. Marques de ValdecillaSantanderSpain39008
73Hosp. Mutua TerrassaTerrassaSpain08221
74Hosp. Univ. Dr. PesetValenciaSpain46017
75Hosp. Clinico Univ. de ValladolidValladolidSpain47003
76University Hospital Birmingham (QE)BirminghamUnited KingdomB15 2TH
77Birmingham Heartlands HospitalBirminghamUnited KingdomB9 5SS
78Southmead HospitalBristolUnited KingdomBS10 5NB
79Maidstone HospitalKentUnited KingdomME16 9QQ
80King's College HospitalLondonUnited KingdomSE5 9RS
81St George's HospitalLondonUnited KingdomSW17 OQT
82Manchester Royal InfirmaryManchesterUnited KingdomM13 9WL
83Wythenshawe HospitalManchesterUnited KingdomM23 9LT
84Nottingham University Hospitals NHS TrustNottinghamUnited KingdomNG5 1PB
85Sheffield Teaching Hospitals NHS Foundation TrustSheffieldUnited KingdomS10 2JF
86The Royal Marsden NHS Trust SuttonSurreyUnited KingdomSM2 5PT

Sponsors and Collaborators

  • Janssen-Cilag Ltd.
  • Legend Biotech

Investigators

  • Study Director: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier:
NCT04035226
Other Study ID Numbers:
  • CR108651
  • 68284528MMY4001
First Posted:
Jul 29, 2019
Last Update Posted:
Dec 3, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2021