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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)
248
Enrollment
86
Locations
38.8
Anticipated Duration (Months)
2.9
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 Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Actual Enrollment :
248 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 :
Oct 27, 2022
Anticipated Study Completion Date :
Oct 27, 2022

Arms and Interventions

Arm 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.

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

Site City State Country Postal Code
1 Oncology Institute of Hope and Innovation Tucson Arizona United States 85745
2 Oncology Institute of Hope and Innovation Corona California United States 92882
3 Oncology Institute of Hope and Innovation Glendale California United States 91204
4 Marin Cancer Center Greenbrae California United States 94904
5 Asclepes Research Weeki Wachee Florida United States 34607
6 Oncology Hematology Assoc of Central Illinois, P.C. d.b.a. Illinois CancerCare, P.C. Peoria Illinois United States 61615
7 Providence Cancer Center Southfield Michigan United States 48075
8 Central Care Cancer Center Bolivar Missouri United States 65613
9 Washington University School of Medicine Saint Louis Missouri United States 63110
10 Optum Care Las Vegas Nevada United States 89102
11 Hunterdon Hematology Oncology Flemington New Jersey United States 08822
12 The Cancer Institute at St. Francis Hospital East Hills New York United States 11548
13 North Shore Hematology Oncology Associates, P.C. East Setauket New York United States 11733
14 The Ohio State University Columbus Ohio United States 43210
15 Grand Hôpital de Charleroi, site Notre Dame Charleroi Belgium 6000
16 Universitair Ziekenhuis Antwerpen Edegem Belgium 2650
17 UZ Leuven Leuven Belgium 3000
18 Ucl de Mont-Godinne Yvoir Belgium 5530
19 Centre Hospitalier du Mans Le Mans France 72000
20 Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez Lille Cedex France 59000
21 CHU de Montpellier, Hopital Saint-Eloi Montpellier France 34295
22 C.H.U. Hotel Dieu - France Nantes France 44093
23 Hopital Saint-Louis Paris cedex 10 France 75475
24 Hopital Saint-Antoine PARIS cedex 12 France 75571
25 CHU de Bordeaux - Hôpital Haut-Lévêque Pessac cedex France 33604
26 Centre hospitalier Lyon-Sud Pierre-Bénite France 69495
27 CHU Poitiers - Hôpital la Milétrie Poitiers France 86021
28 Pôle IUC Oncopole CHU Toulouse cedex 9 France 31059
29 Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik Hamburg Germany 20251
30 Universitaetsklinikum Heidelberg Heidelberg Germany 69120
31 Universitaetsklinikum Koeln Koeln Germany 50397
32 Medizinische Klinik A Muenster Germany 48149
33 Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany Tübingen Germany 72076
34 Universitätsklinikum Würzburg Würzburg Germany 97080
35 U.O. Ematologia con Trapianto- AOU Policlinico di Bari Bari Italy 70124
36 U.O. Ematologia Istituto Tumori Giovanni Paolo II Bari Italy 70124
37 Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi Bologna Italy 40138
38 Policlinico di Catania Catania Italy 95128
39 Azienda Ospedaliera Universitaria Careggi Firenze Italy 50134
40 IRCCS Azienda Ospedaliera San Martino - IST Genova Italy 16132
41 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola Italy 47014
42 Universita degli Studi di Padova - Azienda Ospedaliera di Pa Padova Italy 35128
43 Ospedale Villa Sofia-Cervello Palermo Italy 90146
44 Fondazione IRCCS Policlinico San Matteo Pavia Italy 27100
45 Irccs Crob Rionero in Vulture Italy 85028
46 Università di Roma La Sapienza Roma Italy 00161
47 Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy 00168
48 IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo Italy 71013
49 Ospedale Cardinale G. Panico Tricase Italy 73039
50 A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette Turin Italy 10126
51 VU Medisch Centrum Amsterdam Netherlands 1081 HV
52 UMCG Groningen Netherlands 9713 GZ
53 Erasmus MC - Satellite Rotterdam Netherlands 3075 EA
54 Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich Chorzów Poland 41-500
55 Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie Lublin Poland 20-081
56 Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego Poznan Poland 60-569
57 S.P. Botkin Moscow City Clinical Hospital Moscow Russian Federation 125284
58 City Clinical Hospital # 40 Moscow Russian Federation 129301
59 Nizhniy Novgorod Region Clinical Hospital Nizhny Novgorod Russian Federation 603126
60 Samara Region Clinical Hospital Samara Russian Federation 443095
61 Clinical Research Institute of Hematology and Transfusiology St-Petersburg Russian Federation 191024
62 Hosp. Clinic I Provincial de Barcelona Barcelona Spain 08036
63 Inst. Cat. Doncologia-H Duran I Reynals Barcelona Spain 08908
64 Hosp. Puerta Del Mar Cadiz Spain 11009
65 Hosp. de Jerez de La Frontera Jerez de la Frontera Spain 11407
66 Hosp. de Leon Leon Spain 24080
67 Hosp. Univ. Ramon Y Cajal Madrid Spain 28034
68 Hosp. Univ. 12 de Octubre Madrid Spain 28041
69 Hosp. Univ. Son Espases Palma Spain 7120
70 Clinica Univ. de Navarra Pamplona Spain 31008
71 Hosp. Clinico Univ. de Salamanca Salamanca Spain 37007
72 Hosp. Univ. Marques de Valdecilla Santander Spain 39008
73 Hosp. Mutua Terrassa Terrassa Spain 08221
74 Hosp. Univ. Dr. Peset Valencia Spain 46017
75 Hosp. Clinico Univ. de Valladolid Valladolid Spain 47003
76 University Hospital Birmingham (QE) Birmingham United Kingdom B15 2TH
77 Birmingham Heartlands Hospital Birmingham United Kingdom B9 5SS
78 Southmead Hospital Bristol United Kingdom BS10 5NB
79 Maidstone Hospital Kent United Kingdom ME16 9QQ
80 King's College Hospital London United Kingdom SE5 9RS
81 St George's Hospital London United Kingdom SW17 OQT
82 Manchester Royal Infirmary Manchester United Kingdom M13 9WL
83 Wythenshawe Hospital Manchester United Kingdom M23 9LT
84 Nottingham University Hospitals NHS Trust Nottingham United Kingdom NG5 1PB
85 Sheffield Teaching Hospitals NHS Foundation Trust Sheffield United Kingdom S10 2JF
86 The Royal Marsden NHS Trust Sutton Surrey United Kingdom SM2 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:
Aug 12, 2022
Last Verified:
Aug 1, 2022
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:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of Aug 12, 2022