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
Studienlocations (3 von 77)
Charite Campus Benjamin Franklin 12203 Berlin (Berlin) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Heidelberg 69120 Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Muenster 48149 Muenster (Nordrhein-Westfalen) GermanyAbgeschlossen» Google-Maps
Universitatsklinikum Wurzburg 97080 Wuerzburg (Bayern) GermanyRekrutierend» Google-MapsUniversity of Alabama Birmingham 35294 Birmingham United StatesRekrutierend» Google-MapsUniversity of Arkansas for Medical Sciences 72205 Little Rock United StatesRekrutierend» Google-MapsCity of Hope 91010 Duarte United StatesAbgeschlossen» Google-MapsEmory University - Winship Cancer Institute 30322 Atlanta United StatesRekrutierend» Google-MapsUniversity of Chicago 60637 Chicago United StatesRekrutierend» Google-MapsNorton Cancer Institute 40207 Louisville United StatesRekrutierend» Google-MapsUniversity of Michigan Health System 48109 Ann Arbor United StatesRekrutierend» Google-MapsWashington University School of Medicine 63110 Saint Louis United StatesRekrutierend» Google-MapsNYU Langone Health 10016 New York United StatesRekrutierend» Google-MapsMount Sinai Medical Center 10023 New York United StatesRekrutierend» Google-MapsUniversity of Rochester Medical Center 14642 Rochester United StatesRekrutierend» Google-MapsProvidence Portland Medical Center 97213 Portland United StatesRekrutierend» Google-MapsTennessee Oncology 37203 Nashville United StatesRekrutierend» Google-MapsUCL - Saint Luc 1200 Brussels BelgiumRekrutierend» Google-MapsUZ Antwerpen 2650 Edegem BelgiumRekrutierend» Google-MapsUZ Leuven 3000 Leuven BelgiumRekrutierend» Google-MapsCHU de Liège - Domaine Universitaire du Sart Tilman 4000 Liège BelgiumRekrutierend» Google-MapsPeking University Third Hospital 100191 Beijing ChinaRekrutierend» Google-MapsSun Yat-Sen University Cancer Center 510060 Guangzhou ChinaRekrutierend» Google-MapsThe 1St Affiliated Hospital of Medical College Zhejiang University 310003 Hangzhou ChinaAktiv, nicht rekrutierend» Google-MapsThe 1St Affiliated Hospital of Medical College Zhejiang University 310003 Hangzhou ChinaRekrutierend» Google-MapsFirst Affiliated Hospital SooChow University 215006 Su Zhou ChinaRekrutierend» Google-MapsInstitute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science 300320 Tianjin ChinaRekrutierend» Google-MapsThe First Affiliated Hospital of Xian Jiaotong University 710063 XI An Shi ChinaRekrutierend» Google-MapsThe Second Affiliated Hospital of Xi'an Jiaotong University 710004 Xi'an ChinaAbgeschlossen» Google-MapsCHU Henri Mondor 94000 Creteil FranceRekrutierend» Google-MapsCHU de Montpellier, Hopital Saint-Eloi 34295 Montpellier FranceRekrutierend» Google-MapsC.H.U. Hotel Dieu - France 44093 Nantes FranceRekrutierend» Google-MapsCHU de Bordeaux - Hospital Haut-Leveque 33604 Pessac cedex FranceRekrutierend» Google-MapsCentre hospitalier Lyon-Sud 69495 Pierre Benite cedex FranceRekrutierend» Google-MapsPôle IUC Oncopole CHU 31059 Toulouse cedex 9 FranceRekrutierend» Google-MapsRambam Medical Center 31096 Haifa IsraelRekrutierend» Google-MapsCarmel Medical Center 3436212 Haifa IsraelRekrutierend» Google-MapsHadassah Medical Center 91120 Jerusalem IsraelRekrutierend» Google-MapsSheba Medical Center 52621 Ramat Gan IsraelRekrutierend» Google-MapsTel Aviv Sourasky Medical Center 64239 Tel Aviv IsraelRekrutierend» Google-MapsKameda General Hospital 296-8602 Chiba JapanAktiv, nicht rekrutierend» Google-MapsFukuoka University Hospital 814-0180 Fukuoka JapanAktiv, nicht rekrutierend» Google-MapsOgaki Municipal Hospital 503-8502 Gifu JapanAktiv, nicht rekrutierend» Google-MapsTeine Keijinkai Hospital 006-8555 Hokkaido JapanAktiv, nicht rekrutierend» Google-MapsKobe City Medical Center General Hospital 650-0047 Hyogo JapanAktiv, nicht rekrutierend» Google-MapsDokkyo Medical University Saitama Medical Center 343-8555 Koshigaya JapanAktiv, nicht rekrutierend» Google-MapsKumamoto University Hospital 860-8556 Kumamoto JapanAktiv, nicht rekrutierend» Google-MapsKurashiki Central Hospital 710-8602 Kurashiki JapanAktiv, nicht rekrutierend» Google-MapsNational Hospital Organization Matsumoto Medical Center 399-8701 Matsumoto JapanAktiv, nicht rekrutierend» Google-MapsNational Hospital Organization Okayama Medical Center 701-1192 Okayama JapanAktiv, nicht rekrutierend» Google-MapsJapanese Red Cross Osaka Hospital 543-8555 Osaka JapanAktiv, nicht rekrutierend» Google-MapsHiroshima West Medical Center 739-0696 Otake JapanAktiv, nicht rekrutierend» Google-MapsIwate Medical University Hospital 028-3695 Shiwa-gun JapanAktiv, nicht rekrutierend» Google-MapsChonnam National University Hwasun Hospital 58128 Jeollanam-do Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital, Yonsei University Health System 03722 Seoul Korea, Republic ofAbgeschlossen» Google-MapsAsan Medical Center 05505 Seoul Korea, Republic ofAbgeschlossen» Google-MapsSamsung Medical Center 06351 Seoul Korea, Republic ofAbgeschlossen» Google-MapsThe Catholic University of Korea Seoul St. Mary's Hospital 06591 Seoul Korea, Republic ofRekrutierend» Google-MapsVU Medisch Centrum 1081 HV Amsterdam NetherlandsRekrutierend» Google-MapsUMCU 3584 CX Utrecht NetherlandsAbgeschlossen» Google-MapsUniwersyteckie Centrum Kliniczne 80-214 Gdansk PolandAktiv, nicht rekrutierend» Google-MapsNarodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach 44102 Gliwice PolandAbgeschlossen» Google-MapsUniwersytecki Szpital Kliniczny w Poznaniu 60-569 Poznan PolandAktiv, nicht rekrutierend» Google-MapsNarodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy 02-781 Warszawa PolandAktiv, nicht rekrutierend» Google-MapsUniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu 52-007 Wroclaw PolandAktiv, nicht rekrutierend» Google-MapsHosp. Univ. Germans Trias I Pujol 08916 Badalona SpainRekrutierend» Google-MapsHosp. Univ. Vall D Hebron 08035 Barcelona SpainRekrutierend» Google-MapsInst. Cat. Doncologia-H Duran I Reynals 8908 Barcelona SpainRekrutierend» Google-MapsHosp. Univ. Fund. Jimenez Diaz 28040 Madrid SpainAbgeschlossen» Google-MapsHosp. Univ. 12 de Octubre 28041 Madrid SpainRekrutierend» Google-MapsHosp. Univ. Virgen de La Arrixaca 30120 Murcia SpainRekrutierend» Google-MapsClinica Univ. de Navarra 31008 Pamplona SpainRekrutierend» Google-MapsHosp. Quiron Madrid Pozuelo 28223 Pozuelo de Alarcon SpainRekrutierend» Google-MapsHosp. Clinico Univ. de Salamanca 37007 Salamanca SpainRekrutierend» Google-MapsHosp. Univ. Marques de Valdecilla 39008 Santander SpainRekrutierend» Google-MapsHosp. Virgen Del Rocio 41013 Sevilla SpainRekrutierend» Google-Maps
1. Overall Response Rate (ORR) (Time Frame - Up to 2 years and 10 months): ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.
Secondary outcome:
1. Duration of Response (DOR) (Time Frame - Up to 2 years and 10 months): DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria, or death due to PD, whichever occurs first.
2. Very Good Partial Response (VGPR) or Better Rate (Time Frame - Up to 2 years and 10 months): VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.
3. Complete Response (CR) or Better Rate (Time Frame - Up to 2 years and 10 months): CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria.
4. Stringent Complete Response (sCR) Rate (Time Frame - Up to 2 years and 10 months): sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria.
5. Time to Response (TTR) (Time Frame - Up to 2 years and 10 months): TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.
6. Progression-Free Survival (PFS) (Time Frame - Up to 2 years and 10 months): PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.
7. Overall Survival (OS) (Time Frame - Up to 2 years and 10 months): OS is defined as the time from the date of first dose of study drug to the date of the participant's death.
8. Minimal Residual Disease (MRD) Negative Rate (Time Frame - Up to 2 years and 10 months): MRD negativity rate is measured only for participants who achieve at least a CR but is reported based on all treated similar to the other response data.
9. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Time Frame - Up to 2 years and 10 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.
10. Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability (Time Frame - Up to 2 years and 10 months): An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
11. Number of Participants with AEs by Severity (Time Frame - Up to 2 years and 10 months): Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
12. Number of Participants with Abnormalities in Clinical Laboratory Values (Time Frame - Up to 2 years and 10 months): Number of participants with abnormalities in clinical laboratory values (such as hematology, serum chemistry and coagulation) will be reported.
13. Serum Concentration of Talquetamab (Time Frame - Up to 2 years and 10 months): Serum samples will be analyzed to determine concentrations of talquetamab.
14. Number of Participants with Talquetamab Antibodies (Time Frame - Up to 2 years and 10 months): Antibodies to talquetamab will be assessed to evaluate potential immunogenicity.
15. Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30) (Time Frame - Baseline up to 2 years and 10 months): The EORTC- QLQ-Core-30 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/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week ("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 higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
16. Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L) (Time Frame - Baseline up to 2 years and 10 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). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers.
17. Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS) (Time Frame - Baseline up to 2 years and 10 months): The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).
18. Overall Response Rate (ORR) in Participants with High-risk Molecular Features (Time Frame - Up to 2 years and 10 months): ORR in participants with high risk is defined as the overall response rate among the high risk molecular subgroups or other high-risk molecular subtypes.
Experimental: Part 3: Cohort A (Talquetamab) Cohort A will enroll participants with multiple myeloma who have previously received greater than or equal to (>=) 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study.
Experimental: Part 3: Cohort B (Talquetamab) Cohort B will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study.
Experimental: Part 3: Cohort C (Talquetamab) Cohort C will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study.
Experimental: Part 3: Cohort D (Talquetamab) Cohort D will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study.
