Clinical trial NCT05160584: A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma
Official title: A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Relapsed/Refractory Multiple Myeloma
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2021-12-16
Enrollment: 300
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: The study population consists of participants with previously treated multiple myeloma, having received standard of care (SOC) antimyeloma treatments during local clinical practices.

Brief summary: The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.


Eligibility criteria: Inclusion Criteria:

For Period 1, 2 and 3

* Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria
* 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
* Participants must sign an informed consent form (ICF) indicating that he or she understands the purpose and observational nature of the study and is willing to participate. Consent is to be obtained prior to the initiation of any study-related data collection
* For Period 1 and 2: Received at least 3 prior lines of therapy (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the line of therapy
* Must have documented evidence of progressive disease based on participating physician's determination of response by the IMWG response criteria on or after the last regimen. Participants with documented evidence of progressive disease within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are also eligible
* Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level 1.0 g/dL or urine M-protein level 200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
* Period 1: Received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody (prior exposure can be from different monotherapy or combination regimens)
* Period 2: Received as part of previous therapy a PI, an IMiD, an anti-CD38 antibody, and BCMA-targeted therapy (prior exposure can be from different monotherapy or combination regimens)
* For period 3: Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level .5 g/dL or urine M-protein level 200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 35 months
Secondary outcomes:
measure: Very Good Partial Response (VGPR) Rate
timeFrame: Up to 35 months
measure: Complete Response (CR) Rate
timeFrame: Up to 35 months
measure: Stringent Complete Response (sCR) Rate
timeFrame: Up to 35 months
measure: Minimal Residual Disease (MRD) Negative Rate
timeFrame: Up to 35 months
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to 35 months
measure: Duration of Response (DOR)
timeFrame: Up to 35 months
measure: Time to Response (TTR)
timeFrame: Up to 35 months
measure: Time to Best Response
timeFrame: Up to 35 months
measure: Time to Next Treatment (TTNT)
timeFrame: Up to 35 months
measure: Progression-free Survival (PFS)
timeFrame: Up to 35 months
measure: Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (PFS2)
timeFrame: Up to 35 months
measure: Overall Survival (OS)
timeFrame: Up to 35 months
measure: Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
timeFrame: Baseline up to 35 months
measure: Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
timeFrame: Baseline up to 35 months
measure: Period 1 and 2: Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EORTC QLQ-IL39
timeFrame: Baseline up to 35 months
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 35 months
measure: Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
timeFrame: Up to 35 months
measure: Period 3: Number of Participants Reporting Oral Toxicities Using Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Up to 35 months
measure: Period 3: Number of Participants Reporting Oral Toxicity Symptoms Using the Epstein Taste Survey (ETS)
timeFrame: Up to 35 months
measure: Period 3: Percentage of Participants with Overall Response to Subsequent Therapies
timeFrame: Up to 35 months
Other outcomes:
Locations:
city: Leoben
country: Austria
facility: LKH Leoben
city: Wien
country: Austria
facility: Krankenhaus der barmherzigen Schwestern
city: Leuven
country: Belgium
facility: UZ Leuven
city: Mons
country: Belgium
facility: Chu Helora Hospital De Mons Site Kennedy
city: Yvoir
country: Belgium
facility: Ucl de Mont-Godinne
city: Lille
country: France
facility: CHRU de Lille Hopital Claude Huriez
city: Montpellier Cedex 5
country: France
facility: CHU de Montpellier Hopital Saint Eloi
city: Nantes Cedex 1
country: France
facility: CHU de Nantes hotel Dieu
city: Pierre-Bénite
country: France
facility: Centre hospitalier Lyon-Sud
city: Toulouse cedex 9
country: France
facility: Pôle IUC Oncopole CHU
city: Berin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden
city: Hamburg
country: Germany
facility: Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik
city: Hamm
country: Germany
facility: St. Barbara-Klinik Hamm GmbH
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Karlsruhe
country: Germany
facility: Staedtisches Klinikum Karlsruhe gGmbH
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
city: Leipzig
country: Germany
facility: MVZ Mitte-Onkologische Schwerpunktpraxis
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
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: Zwickau
country: Germany
facility: Heinrich-Braun-Klinikum gGmbH
city: Alexandroupoli
country: Greece
facility: University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: Alexandra Hospital
city: Rio
country: Greece
facility: General University Hospital of Patras
city: Thessaloniki
country: Greece
facility: Anticancer Hospital of Thessaloniki Theageneio
city: Bari
country: Italy
facility: U.O. Ematologia Istituto Tumori Giovanni Paolo II
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: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera San Martino - IST
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino IRCCS
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
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: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
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: Casa Sollievo Della Sofferenza IRCCS
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
city: Tricase
country: Italy
facility: Ospedale Cardinale G. Panico
city: Vicenza
country: Italy
facility: Azienda Ulss 8 Berica- Ospedale Di Vicenza
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Groningen
country: Netherlands
facility: UMCG
city: Barcelona
country: Spain
facility: Inst. Cat. Doncologia-H Duran I Reynals
city: Gijón
country: Spain
facility: Hosp. de Cabuenes
city: Granada
country: Spain
facility: Hosp. Univ. Virgen de Las Nieves
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: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Valencia
country: Spain
facility: Hosp. Clinico Univ. de Valencia
city: Valencia
country: Spain
facility: Hosp. Univ. Dr. Peset
city: Valladolid
country: Spain
facility: Hosp. Clinico Univ. de Valladolid
city: Zaragoza
country: Spain
facility: Hosp. Univ. Miguel Servet
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: London
country: United Kingdom
facility: University College Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone 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 Pharmaceutica N.V., Belgium
name: Janssen Pharmaceutica N.V., Belgium Clinical Trial
role: STUDY_DIRECTOR
References: