Clinical trial NCT04035226: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Legend Biotech
First posted: 2019-07-29
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Very Good Partial Response (VGPR) Rate
timeFrame: Up to 24 months
measure: Complete Response (CR) Rate
timeFrame: Up to 24 months
measure: Stringent Complete Response (sCR) Rate
timeFrame: Up to 24 months
measure: Minimal Residual Disease (MRD) Negative Rate
timeFrame: Up to 24 months
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to 24 months
measure: Duration of Response
timeFrame: Up to 24 months
measure: Time to Response
timeFrame: Up to 24 months
measure: Time to Next Treatment [TTNT]
timeFrame: Up to 24 months
measure: Progression-free Survival (PFS)
timeFrame: Up to 24 months
measure: Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death (PFS2)
timeFrame: Up to 24 months
measure: Overall Survival (OS)
timeFrame: Up to 24 months
measure: Change from Baseline in Health-related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Scale Score
timeFrame: Baseline up to 24 months
measure: Change from Baseline in Health-related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer (EORTC) QLQ-MY20 Scale Score
timeFrame: Baseline up to 24 months
measure: Change from Baseline in Health-related Quality of Life (HRQoL) using EQ-5D-5L Questionnaire Score
timeFrame: Baseline up to 24 months
measure: Number of Patients with Adverse Events (AEs)
timeFrame: Up to 24 months
measure: Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Oncology Institute of Hope and Innovation
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Center
state: California
city: Weeki Wachee
country: United States
facility: Asclepes Research
state: Florida
city: Peoria
country: United States
facility: Oncology Hematology Assoc of Central Illinois, P.C. d.b.a. Illinois CancerCare, P.C.
state: Illinois
city: Southfield
country: United States
facility: Providence Cancer Center
state: Michigan
city: Bolivar
country: United States
facility: Central Care Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Optum Care
state: Nevada
city: Flemington
country: United States
facility: Hunterdon Hematology Oncology
state: New Jersey
city: East Hills
country: United States
facility: The Cancer Institute at St. Francis Hospital
state: New York
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates, P.C.
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi, site Notre Dame
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven
city: Yvoir
country: Belgium
facility: Ucl de Mont-Godinne
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lille Cedex
country: France
facility: Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
city: Montpellier
country: France
facility: CHU de Montpellier Hopital Saint Eloi
city: Nantes
country: France
facility: C.H.U. Hotel Dieu - France
city: Paris cedex 10
country: France
facility: Hopital Saint Louis
city: PARIS cedex 12
country: France
facility: Hopital Saint-Antoine
city: Pierre-Bénite
country: France
facility: Centre hospitalier Lyon-Sud
city: Poitiers
country: France
facility: CHU Poitiers - Hopital la Miletrie
city: Toulouse cedex 9
country: France
facility: Pôle IUC Oncopole CHU
city: Hamburg
country: Germany
facility: Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Koeln
country: Germany
facility: Universitaetsklinikum Koelnt
city: Muenster
country: Germany
facility: Medizinische Klinik A
city: Tubingen
country: Germany
facility: Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
city: Wuerzburg
country: Germany
facility: Universitatsklinikum Wurzburg
city: Bari
country: Italy
facility: U.O. Ematologia con Trapianto- AOU Policlinico di Bari
city: Bari
country: Italy
facility: U.O. Ematologia Istituto Tumori Giovanni Paolo II
city: Bologna
country: Italy
facility: Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
city: Catania
country: Italy
facility: Policlinico di Catania
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera San Martino - IST
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Padova
country: Italy
facility: Universita degli Studi di Padova Azienda Ospedaliera di Pa
city: Palermo
country: Italy
facility: Ospedale Villa Sofia-Cervello
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Rionero in Vulture
country: Italy
facility: Irccs Crob
city: Roma
country: Italy
facility: Università di Roma La Sapienza
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli IRCCS
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
city: Tricase
country: Italy
facility: Ospedale Cardinale G. Panico
city: Turin
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Groningen
country: Netherlands
facility: UMCG
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Satellite
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
city: Poznan
country: Poland
facility: Szpital Kliniczny im H Swiecickiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu
city: Moscow
country: Russian Federation
facility: S.P. Botkin Moscow City Clinical Hospital
city: Samara
country: Russian Federation
facility: Samara Region Clinical Hospital
city: St-Petersburg
country: Russian Federation
facility: Clinical Research Institute of Hematology and Transfusiology
city: Barcelona
country: Spain
facility: Inst. Cat. Doncologia-H Duran I Reynals
city: Cadiz
country: Spain
facility: Hosp. Puerta Del Mar
city: Jerez de la Frontera
country: Spain
facility: Hosp. de Jerez de La Frontera
city: Leon
country: Spain
facility: Hosp. de Leon
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Palma
country: Spain
facility: Hosp. Univ. Son Espases
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Terrassa
country: Spain
facility: Hosp. Mutua Terrassa
city: Valencia
country: Spain
facility: Hosp. Univ. Dr. Peset
city: Valladolid
country: Spain
facility: Hosp. Clinico Univ. de Valladolid
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Kent
country: United Kingdom
facility: Maidstone Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Surrey
country: United Kingdom
facility: The Royal Marsden NHS Trust Sutton
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.