A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide
Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Kontakt
Study Contact Kontakt: Phone: 844-434-4210 E-Mail: Participate-In-This-Study@its.jnj.com» Kontaktdaten anzeigen
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Darmzentrum Klinikum Augsburg Stenglinstraße 2 86156 Augsburg DeutschlandRekrutierend» Google-MapsUniversitaetsklinikum Halle (Saale) 06120 Halle (Saale) (Sachsen-Anhalt) GermanyRekrutierend» Google-MapsKlinikum rechts der Isar der TU Muenchen 81675 München (Bayern) GermanyRekrutierend» Google-Maps
Universitaetsklinikum Tuebingen 72076 Tuebingen (Baden-Württemberg) GermanyRekrutierend» Google-MapsRoyal Adelaide Hospital 5000 Adelaide AustraliaRekrutierend» Google-MapsBox Hill Hospital 3128 Box Hill AustraliaRekrutierend» Google-MapsSt. Vincent's Hospital 2010 Darlinghurst AustraliaRekrutierend» Google-MapsSt. Vincent's Hospital Melbourne 3065 Fitzroy AustraliaRekrutierend» Google-MapsGold Coast University Hospital 4215 Southport AustraliaRekrutierend» Google-MapsWollongong Hospital 2500 Wollongong AustraliaRekrutierend» Google-MapsGrand Hopital de Charleroi, site Notre Dame 6000 Charleroi BelgiumRekrutierend» Google-MapsZiekenhuis Oost-Limburg 3600 Genk BelgiumRekrutierend» Google-MapsGhent University Hospital 9000 Gent BelgiumRekrutierend» Google-MapsAZ Nikolaas - Campus Sint-Niklaas Moerland 9100 Sint-Niklaas BelgiumRekrutierend» Google-MapsJuravinski Cancer Centre L8V5C2 Hamilton CanadaRekrutierend» Google-MapsUniversity Health Network (UHN) Princess Margaret Cancer Centre M5G 2M9 Toronto CanadaRekrutierend» Google-MapsCIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont H1T 2M4 Montreal CanadaRekrutierend» Google-MapsPeking University People s Hospital 100044 Beijing ChinaRekrutierend» Google-MapsFakultni nemocnice Brno 625 00 Brno - Bohunice CzechiaRekrutierend» Google-MapsFakultni nemocnice Hradec Kralove 500 05 Hradec Kralove CzechiaRekrutierend» Google-MapsFakultni nemocnice Ostrava 708 52 Ostrava CzechiaRekrutierend» Google-MapsAarhus University Hospital 8200 Aarhus DenmarkRekrutierend» Google-MapsOdense University Hospital 5000 Odense C DenmarkRekrutierend» Google-MapsVejle Hospital 7100 Vejle DenmarkRekrutierend» Google-MapsCHU de Limoges Hopital Dupuytren 87042 Limoges FranceRekrutierend» Google-MapsInstitut Paoli Calmettes 13009 Marseille FranceRekrutierend» Google-MapsCHU Nantes 44093 Nantes FranceRekrutierend» Google-MapsCHU de Bordeaux - Hospital Haut-Leveque 33604 Pessac Cedex FranceRekrutierend» Google-MapsCHU Lyon Sud 69495 Pierre-Benite FranceRekrutierend» Google-MapsInstitut Universitaire du Cancer Toulouse Oncopole 31100 Toulouse Cedex 9 FranceRekrutierend» Google-MapsCHRU Tours Hopital Bretonneau 37044 TOURS Cedex 01 FranceRekrutierend» Google-MapsDeenanath Mangeshkar Hospital and Research Centre 411004 Pune IndiaRekrutierend» Google-MapsShamir Medical Center (Assaf Harofeh) 70300 Be'er Ya'akov IsraelRekrutierend» Google-MapsCarmel Medical Center 3436212 Haifa IsraelRekrutierend» Google-MapsRabin Medical center - Petah-Tikva 49100 Petah-Tikva IsraelRekrutierend» Google-MapsSheba Medical Center 52621 Ramat Gan IsraelRekrutierend» Google-MapsTel Aviv Sourasky Medical Center 64239 Tel Aviv-Yafo IsraelRekrutierend» Google-MapsAzienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria 15121 Alessandria ItalyRekrutierend» Google-Mapsoncologia medica - Oncology 72100 Brindisi ItalyRekrutierend» Google-MapsAsst Ovest Milanese - Ospedale Di Legnano 20025 Legnano ItalyRekrutierend» Google-MapsFondazione IRCCS Policlinico San Matteo 27100 Pavia ItalyRekrutierend» Google-MapsPresidio Ospedaliero Pescara 65124 Pescara ItalyRekrutierend» Google-MapsOspedale S. Maria Delle Croci 48121 Ravenna ItalyRekrutierend» Google-MapsJuntendo University Hospital 113 8431 Bunkyo Ku JapanRekrutierend» Google-MapsKanazawa University Hospital 920-8641 Kanazawa JapanRekrutierend» Google-MapsUniversity Hospital Kyoto Prefectural University of Medicine 602-8566 Kyoto JapanRekrutierend» Google-MapsNiigata Cancer Center Hospital 951-8566 Niigata JapanRekrutierend» Google-MapsIwate Medical University Hospital 028-3695 Shiwa-gun JapanRekrutierend» Google-MapsOsaka University Hospital 565-0871 Suita-City JapanRekrutierend» Google-MapsTottori University Hospital 683-0824 Tottori JapanRekrutierend» Google-MapsKanagawa Cancer Center 241 8515 Yokohama City JapanRekrutierend» Google-MapsDong-A University Hospital 49201 Busan Korea, Republic ofRekrutierend» Google-MapsPusan National University Hospital 49241 Busan Korea, Republic ofRekrutierend» Google-MapsChonnam National University Hwasun Hospital 58128 Jeollanam-do Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsSamsung Medical Center 06351 Seoul Korea, Republic ofRekrutierend» Google-MapsThe Catholic University of Korea Seoul St. Mary's Hospital 06591 Seoul Korea, Republic ofRekrutierend» Google-MapsUlsan University Hospital 44033 Ulsan Korea, Republic ofRekrutierend» Google-MapsFlevoziekenhuis 1315RA Almere NetherlandsRekrutierend» Google-MapsHaga ziekenhuis 2545 CH Den Haag NetherlandsRekrutierend» Google-MapsCatharinaziekenhuis 5623 EJ Eindhoven NetherlandsRekrutierend» Google-MapsSt. Antonius Ziekenhuis Nieuwegein 3435 CM Nieuwegein NetherlandsRekrutierend» Google-MapsIsala Kliniek 8025 AB Zwolle NetherlandsRekrutierend» Google-MapsSzpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza 36-200 Brzozow PolandRekrutierend» Google-MapsSwietokrzyskie Centrum Onkologii SPZOZ w Kielcach 25-734 Kielce PolandRekrutierend» Google-MapsCentrum Onkologii Ziemii Lubelskiej 20-090 Lublin PolandRekrutierend» Google-MapsUniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie 71-252 Szczecin PolandRekrutierend» Google-MapsUniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu 52-007 Wroclaw PolandRekrutierend» Google-MapsHosp. de Cabuenes 33394 Asturias SpainRekrutierend» Google-MapsHosp. Univ. de Burgos 09003 Burgos SpainRekrutierend» Google-MapsHosp. San Pedro de Alcantara 10003 Cáceres SpainRekrutierend» Google-MapsHosp. Univ. Virgen de Las Nieves 18014 Granada SpainRekrutierend» Google-MapsHosp. Univ. Lucus Augusti 27003 Lugo SpainRekrutierend» Google-MapsHosp. Univ. La Paz 28046 Madrid SpainRekrutierend» Google-MapsHosp. Univ. Son Espases 07120 Palma de Mallorca SpainRekrutierend» Google-MapsClinica Univ. de Navarra 31008 Pamplona SpainRekrutierend» Google-MapsHosp. Clinico Univ. de Salamanca 37007 Salamanca SpainRekrutierend» Google-MapsHosp. Univ. Donostia 20014 San Sebastian SpainRekrutierend» Google-MapsHosp. Clinico Univ. de Santiago 15706 Santiago de Compostela SpainRekrutierend» Google-MapsSkanes universitetssjukhus 221 85 Lund SwedenRekrutierend» Google-MapsAkademiska Sjukhuset 75185 Uppsala SwedenRekrutierend» Google-MapsVarberg Hospital 432 81 Varberg SwedenRekrutierend» Google-MapsUniversity Hospital of Wales CF14 4HY Cardiff United KingdomRekrutierend» Google-MapsUniversity Hospitals Plymouth NHS Trust PL6 8DH Plymouth United KingdomRekrutierend» Google-Maps
1. Progression Free Survival (PFS) (Time Frame - Up to 6 years 5 months): PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first.
Secondary outcome:
1. Overall Response Rate (ORR) (Time Frame - Up to 6 years 5 months): ORR is defined as the percentage of participants with best overall response of partial response (PR) or better according to international myeloma working group (IMWG) response criteria.
2. Complete Response (CR) or Better Rate (Time Frame - Up to 6 years 5 months): CR or better is defined as the percentage of participants with best overall response of CR or better according to IMWG response criteria.
3. Very Good Partial Response (VGPR) or Better Rate (Time Frame - Up to 6 years 5 months): VGPR or better is defined as the percentage of participants with best overall response of VGPR or better rate according to IMWG response criteria.
4. Minimal Residual Disease (MRD)-negative CR Rate (Time Frame - Up to 6 years 5 months): MRD-negative CR is defined as the percentage of participants who achieve both CR or better and MRD negativity at a threshold of 10^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy (SST).
5. Overall Survival (OS) (Time Frame - Up to 6 years 5 months): OS is defined as the time from randomization to the date of participant's death.
6. Progression Free Survival on Next-line Therapy (PFS2) (Time Frame - Up to 6 years 5 months): PFS2 is defined as time from randomization to progression on the next line of therapy or death, whichever comes first.
7. Time to Next Treatment (TTNT) (Time Frame - Up to 6 years 5 months): TTNT is defined as the time from randomization to the start of SST.
8. Serum Concentration of Talquetamab and Teclistamab (Time Frame - Up to 6 years 5 months): Serum concentration of talquetamab and teclistamab will be reported.
9. Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab (Time Frame - Up to 6 years 5 months): Number of participants with ADAs to talquetamab and teclistamab will be reported.
10. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) (Time Frame - Up to 6 years 5 months): Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale.
11. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30 (Time Frame - Up to 6 years 5 months): Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and 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.
12. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) (Time Frame - Up to 6 years 5 months): Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
13. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression -Severity (PGI-S) (Time Frame - Up to 6 years 5 months): Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe."
14. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey (Time Frame - Up to 6 years 5 months): Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The epstein taste survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes developed for use in patients with head and neck cancer as a composite of the Vanderbilt Head and Neck Symptom Survey.
15. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q (Time Frame - Up to 6 years 5 months): Change from baseline in symptoms, functioning, and HRQoL as assessed by MySIm-Q will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale.
16. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30 (Time Frame - Up to 6 years 5 months): Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and 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 or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems.
17. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L (Time Frame - Up to 6 years 5 months): Change from baseline in symptoms, functioning, and HRQoL as assessed by EQ-5D-5L will be reported. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
18. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S (Time Frame - Up to 6 years 5 months): Change from baseline in symptoms, functioning, and HRQoL as assessed by PGI-S will be reported. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe."
19. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey (Time Frame - Up to 6 years 5 months): Change from baseline in symptoms, functioning, and HRQoL as assessed by epstein taste survey will be reported. The epstein taste survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes. developed for use in patients with head and neck cancer as a composite of the Vanderbilt Head and Neck Symptom Survey.
20. Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30 (Time Frame - Up to 6 years 5 months): Percentage of participants with meaningful improvement in HRQol as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and 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 or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems.
Experimental: Arm A: Talquetamab + Pomalidomide (Tal-P) Participants will receive talquetamab as subcutaneous (SC) injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Experimental: Arm B: Talquetamab + Teclistamab (Tal-Tec) Participants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Active Comparator: Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd) Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per investigator choice. Dexamethasone will be administered as a pretreatment medication.
Talquetamab (JNJ-64407564 / Talvey / ): Talquetamab will be administered as a SC injection.
Pomalidomide (Pomalyst / Imnovid / ): Pomalidomide will be administered orally.
Teclistamab (JNJ-64007957 / Tecvayli / ): Teclistamab will be administered as a SC injection.
Elotuzumab (Empliciti): Elotuzumab will be administered intravenously.
Dexamethasone: Dexamethasone will be administered either orally or intravenously.
Bortezomib (Velcade): Bortezomib will be administered as a SC injection.
Quelle: ClinicalTrials.gov
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"A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide"
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