Janssen Pharmaceutica N.V., Belgium Clinical Trial Study Director Janssen Pharmaceutica N.V., Belgium
Kontakt
Study Contact Kontakt: Phone: 844-434-4210 E-Mail: Participate-In-This-Study@its.jnj.com» Kontaktdaten anzeigen
Studienlocations (3 von 48)
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin 12203 Berin (Berlin) GermanyRekrutierend» Google-MapsUniversitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden 01307 Dresden (Sachsen) GermanyRekrutierend» Google-MapsUniversitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik 20251 Hamburg (Hamburg) GermanyRekrutierend» Google-Maps
Universitaetsklinikum Heidelberg 69120 Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Koeln 50397 Koeln (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Leipzig 4103 Leipzig (Sachsen) GermanyRekrutierend» Google-MapsKlinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany 72076 Tubingen (Baden-Württemberg) GermanyRekrutierend» Google-MapsUniversitatsklinikum Wurzburg 97080 Wuerzburg (Bayern) GermanyRekrutierend» Google-MapsUZ Leuven 3000 Leuven BelgiumAbgeschlossen» Google-MapsUcl de Mont-Godinne 5530 Yvoir BelgiumAbgeschlossen» Google-MapsCHRU de Lille - Hopital Claude Huriez 59037 Lille FranceAktiv, nicht rekrutierend» Google-MapsCHU de Montpellier, Hopital Saint-Eloi 34295 Montpellier Cedex 5 FranceAktiv, nicht rekrutierend» Google-MapsCHU de Nantes hotel Dieu 44093 Nantes Cedex 1 FranceAbgeschlossen» Google-MapsCentre hospitalier Lyon-Sud 69495 Pierre-Bénite FranceAktiv, nicht rekrutierend» Google-MapsPôle IUC Oncopole CHU 31059 Toulouse cedex 9 FranceAktiv, nicht rekrutierend» Google-MapsU.O. Ematologia Istituto Tumori Giovanni Paolo II 70124 Bari ItalyAbgeschlossen» Google-MapsIstituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi 40138 Bologna ItalyAktiv, nicht rekrutierend» Google-MapsPoliclinico di Catania 95128 Catania ItalyAktiv, nicht rekrutierend» Google-MapsIRCCS Azienda Ospedaliera San Martino - IST 16132 Genova ItalyAbgeschlossen» Google-MapsIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori 47014 Meldola ItalyAktiv, nicht rekrutierend» Google-MapsUniversita degli Studi di Padova Azienda Ospedaliera di Pa 35128 Padova ItalyAktiv, nicht rekrutierend» Google-MapsOspedale Villa Sofia-Cervello 90146 Palermo ItalyAktiv, nicht rekrutierend» Google-MapsFondazione IRCCS Policlinico San Matteo 27100 Pavia ItalyAktiv, nicht rekrutierend» Google-MapsUniversità di Roma La Sapienza 00161 Roma ItalyAbgeschlossen» Google-MapsFondazione Policlinico Universitario A Gemelli IRCCS 00168 Roma ItalyAktiv, nicht rekrutierend» Google-MapsIRCCS Ospedale Casa Sollievo della Sofferenza 71013 San Giovanni Rotondo ItalyAbgeschlossen» Google-MapsOspedale Cardinale G. Panico 73039 Tricase ItalyAbgeschlossen» Google-MapsVU Medisch Centrum 1081 HV Amsterdam NetherlandsAbgeschlossen» Google-MapsUMCG 9713 GZ Groningen NetherlandsAktiv, nicht rekrutierend» Google-MapsInst. Cat. Doncologia-H Duran I Reynals 08908 Barcelona SpainAbgeschlossen» Google-MapsHosp. de Cabuenes 33394 Gijón SpainAktiv, nicht rekrutierend» Google-MapsHosp. de Jerez de La Frontera 11407 Jerez de la Frontera SpainAbgeschlossen» Google-MapsHosp. de Leon 24008 Leon SpainAbgeschlossen» Google-MapsHosp. Univ. Ramon Y Cajal 28034 Madrid SpainAbgeschlossen» Google-MapsHosp. Univ. 12 de Octubre 28041 Madrid SpainAbgeschlossen» Google-MapsHosp. Univ. Son Espases 7120 Palma SpainAktiv, nicht rekrutierend» Google-MapsClinica Univ. de Navarra 31008 Pamplona SpainAbgeschlossen» Google-MapsHosp. Clinico Univ. de Salamanca 37007 Salamanca SpainAbgeschlossen» Google-MapsHosp. Univ. Marques de Valdecilla 39008 Santander SpainAbgeschlossen» Google-MapsHosp. Clinico Univ. de Santiago 15706 Santiago de Compostela SpainAbgeschlossen» Google-MapsHosp. Clinico Univ. de Valladolid 47003 Valladolid SpainAbgeschlossen» Google-MapsSouthmead Hospital BS10 5NB Bristol United KingdomAktiv, nicht rekrutierend» Google-MapsUniversity College Hospital NW1 2PG London United KingdomAbgeschlossen» Google-MapsKing s College Hospital SE5 9RS London United KingdomAbgeschlossen» Google-MapsSt George's Hospital SW17 OQT London United KingdomAbgeschlossen» Google-MapsMaidstone Hospital ME16 9QQ Maidstone United KingdomAbgeschlossen» Google-MapsNottingham University Hospitals NHS Trust NG5 1PB Nottingham United KingdomAktiv, nicht rekrutierend» Google-MapsThe Royal Marsden NHS Trust Sutton SM2 5PT Surrey United KingdomAbgeschlossen» Google-Maps
1. Overall Response Rate (ORR) (Time Frame - Up to 35 months): Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC).
Secondary outcome:
1. Very Good Partial Response (VGPR) Rate (Time Frame - Up to 35 months): VGPR rate is defined as the percentage of participants who achieve a VGPR or better response according to IMWG response criteria.
2. Complete Response (CR) Rate (Time Frame - Up to 35 months): CR rate is defined as the percentage of participants who achieve a CR or better response according to IMWG response criteria.
3. Stringent Complete Response (sCR) Rate (Time Frame - Up to 35 months): sCR rate is defined as the percentage of participants who achieve a sCR according to IMWG response criteria.
4. Minimal Residual Disease (MRD) Negative Rate (Time Frame - Up to 35 months): MRD negative rate is defined as the percentage of participants with negative MRD status according to IMWG response criteria.
5. Clinical Benefit Rate (CBR) (Time Frame - Up to 35 months): CBR is defined as the percentage of participants with clinical benefit. CBR=ORR (sCR + CR + VGPR + PR) + minimal response (MR).
6. Duration of Response (DOR) (Time Frame - Up to 35 months): DOR 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 as defined in the IMWG criteria.
7. Time to Response (TTR) (Time Frame - Up to 35 months): TTR is defined as the time between the date of Day 1 of Cycle 1 and the first clinical response evaluation that the participant has met all criteria for PR or better response.
8. Time to Best Response (Time Frame - Up to 35 months): Time to best response is defined as the time between the date of Day 1 of Cycle 1 and best objective response.
9. Time to Next Treatment (TTNT) (Time Frame - Up to 35 months): TTNT is defined as the time from diagnosis to the start of the next-line treatment.
10. Progression-free Survival (PFS) (Time Frame - Up to 35 months): PFS is defined as the time from the date of Day 1 of Cycle 1 to the date of first documented disease progression (as defined in the IMWG response criteria) or death due to any cause, whichever occurs first.
11. Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (PFS2) (Time Frame - Up to 35 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.
12. Overall Survival (OS) (Time Frame - Up to 35 months): OS is the duration from the date of Day 1 of Cycle 1 to the date of the participant's death or study completion, whichever occurs first.
13. 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 (Time Frame - Baseline up to 35 months): The EORTC-QLQ-C30 Version 3 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
14. 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) (Time Frame - Baseline up to 35 months): The EQ-5D-5L is a generic measure of health status. The 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. Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EORTC QLQ-IL39 (Time Frame - Baseline up to 35 months): EORTC QLQ-IL39 (four single items from the EORTC QLQMY20) 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).
16. Number of Participants with Adverse Events (AEs) (Time Frame - Up to 35 months): An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
17. Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (Time Frame - Up to 35 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.
