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| ID | Type | Description | Link |
|---|---|---|---|
| 79635322MMY3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2025-522007-18-00 | Registry Identifier | EUCT number |
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The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-79635322 | Experimental | Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity. |
|
| Anti BCMAxCD3 Bispecific Antibody | Active Comparator | Participants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-79635322 | Drug | JNJ-79635322 will be administered as SC injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve partial response (PR) or better, according to the international myeloma working group (IMWG) response criteria. | Up to 5 years and 4 months |
| Progression-Free Survival (PFS) | PFS is defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria. | Up to 5 years and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Very Good Partial Response (VGPR) or Better | VGPR or better is defined as the percentage of participants achieving VGPR, complete response (CR), or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. | Up to 5 years and 4 months |
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Inclusion:
Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:
Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD)38 antibody
Documented evidence of progressive disease (PD) or failure to achieve a response (that is partial response [PR] or better) to the last line of therapy based on investigator's determination of response by IMWG criteria
Have discontinued concurrent use of any other anticancer treatment (including nonpalliative radiotherapy) or investigational agent
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the start of study treatment administration
Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAMS | Recruiting | Little Rock | Arkansas | 72205 | United States | |
| USC Norris Comprehensive Cancer Center |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Teclistamab |
| Drug |
Teclistamab will be administered as SC injection. |
|
| Complete Response (CR) or Better |
CR or better is defined as the percentage of participants achieving CR or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. |
| Up to 5 years and 4 months |
| Duration of Response (DoR) | DoR is defined as the time interval between the date of initial documentation of a response (partial response [PR] or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria or death due to any cause, whichever occurs first. | Up to 5 years and 4 months |
| Minimal Residual Disease (MRD)-negative CR | MRD-negative CR is defined as the percentage of participants who achieve MRD-negative status, as determined by next-generation flow cytometry (NGF), at any time point after randomization and prior to PD or subsequent antimyeloma therapy and who achieve CR or better. | Up to 5 years and 4 months |
| MRD-negative CR at 9 months | MRD-negative CR at 9 months is defined as the participants who achieve MRD-negative status at 9 months, as determined by NGF prior to PD or subsequent anti-myeloma therapy and who also achieve CR or better, according to IMWG criteria. | 9 months |
| Sustained MRD-negative CR | Sustained MRD-negative CR is defined as participants with confirmed CR or better who sustain MRD-negative status, as determined by NGF, for at least 12 months without any examination showing MRD-positive status or progressive disease in between. | Up to 5 years and 4 months |
| Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2) | PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. Those who are alive and for whom a second disease progression has not been observed are censored at the last date of follow-up. | Up to 5 years and 4 months |
| Overall Survival (OS) | OS is defined as the time from the date of randomization to the date of the participant's death due to any cause. | Up to 5 years and 4 months |
| Time To Next Line of Therapy (TTNT) | TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment. Death due to progressive disease without the start of any subsequent antimyeloma therapy will be considered as an event. | Up to 5 years and 4 months |
| Number of Participants With Treatment-Emergent Adverse Events (TEAE) by Severity | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy or any AE that is considered treatment-related regardless of the start date of the event is considered to be treatment-emergent. TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0. Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, to Grade 5= death related to adverse event. | Up to 5 years and 4 months |
| Number of Participants with Abnormalities in Clinical Laboratories Results | Number of participants with abnormalities in clinical laboratories results (serum chemistry and hematology) will be reported. | Up to 5 years and 4 months |
| Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Score | Change from baseline in symptoms, functioning, and health-related quality of life (HRQoL) as assessed by multiple myeloma symptom and impact questionnaire (MySIm-Q) score will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment with established content validity for participants with relapsed or refractory multiple myeloma (RRMM) and newly diagnosed MM. | Baseline up to 5 years and 4 months |
| Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Score | Change from baseline in symptoms, functioning, and HRQoL as assessed by european organization for research and treatment of cancer quality of life questionnaire core 30 (EORTC-QLQ-C30) score will be reported. | Baseline up to 5 years and 4 months |
| Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Score | The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (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). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual. | Baseline up to 5 years and 4 months |
| Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score | Time to worsening in symptoms, functioning, and HRQoL as assessed by MySIm-Q score will be reported. The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM. | Up to 5 years and 4 months |
| Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score | Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported. | Up to 5 years and 4 months |
| Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score | The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (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). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual. | Up to 5 years and 4 months |
| Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score | The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM. It is included to be complementary to the EORTC-QLQ-C30. It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days" and responses are reported on a 5-point verbal rating scale. | Up to 5 years and 4 months |
| Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score | Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported. | Up to 5 years and 4 months |
| Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score | The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (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). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual. | Up to 5 years and 4 months |
| Percentage of Participants With Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List 46 (EORTC IL46) | Percentage of participants with side effects burden on the EORTC IL46 will be reported. The EORTC IL46 measures the global impression of burden due to treatment-related symptoms. | Up to 5 years and 4 months |
| Serum Concentrations for JNJ-79635322 | Serum concentrations of JNJ-79635322 will be reported. | Up to 5 years and 4 months |
| Number of Participants With Anti-drug Antibodies (ADA) to JNJ-79635322 | Serum samples will be analyzed for the detection of ADA to JNJ-79635322 using a validated assay method. | Up to 5 years and 4 months |
| Number of Participants With Neutralizing Antibodies (NAb) to JNJ-79635322 | Number of participants who are ADA-positive will be assessed for the presence of NAbs. | Up to 5 years and 4 months |
| Recruiting |
| Los Angeles |
| California |
| 90033 |
| United States |
| University of California San Francisco | Recruiting | San Francisco | California | 94122 | United States |
| Colorado Blood Cancer Institute | Recruiting | Denver | Colorado | 80218 | United States |
| University of Connecticut Health Center | Recruiting | Farmington | Connecticut | 06030 | United States |
| Yale Cancer Center | Recruiting | New Haven | Connecticut | 06510 | United States |
| Florida Cancer Specialists & Research Institute | Recruiting | Fort Myers | Florida | 33901 | United States |
| Moffit Cancer center | Recruiting | Tampa | Florida | 33612 | United States |
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
| University of Iowa Hospital and Clinics | Recruiting | Iowa City | Iowa | 52242 | United States |
| Mission Cancer Blood | Recruiting | Waukee | Iowa | 50263 | United States |
| University of Kansas Cancer Center | Recruiting | Kansas City | Kansas | 66160 | United States |
| Norton Cancer Institute | Recruiting | Louisville | Kentucky | 40207 | United States |
| Mount Sinai Brooklyn | Recruiting | Brooklyn | New York | 11234 | United States |
| NYU Winthrop | Recruiting | Mineola | New York | 11501 | United States |
| Mount Sinai Chelsea | Recruiting | New York | New York | 10011 | United States |
| Laura and Isaac Perlmutter Cancer Center NYU ACC | Recruiting | New York | New York | 10016 | United States |
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| Durham VAMC | Recruiting | Durham | North Carolina | 27705 | United States |
| Oregon Health And Science University | Recruiting | Portland | Oregon | 97239 | United States |
| Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| St. David's South Austin Medical Center | Recruiting | Austin | Texas | 78704 | United States |
| Baylor University Medical Center | Recruiting | Dallas | Texas | 75246 | United States |
| Texas Transplant Institute | Recruiting | San Antonio | Texas | 78229 | United States |
| Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
| Medical College Of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| Box Hill Hospital | Recruiting | Box Hill | 3128 | Australia |
| Mater Misericordiae Ltd | Recruiting | Brisbane | 4101 | Australia |
| Monash Medical Centre | Recruiting | Clayton | 3168 | Australia |
| St Vincents Hospital Melbourne | Recruiting | Fitzroy | 3065 | Australia |
| The Alfred Hospital | Recruiting | Melbourne | 3004 | Australia |
| Fiona Stanley Hospital | Recruiting | Murdoch | 6150 | Australia |
| Sir Charles Gairdner Hospital | Recruiting | Nedlands | 6009 | Australia |
| Gold Coast University Hospital | Recruiting | Southport | 4215 | Australia |
| Arthur J E Child Comprehensive Cancer Centre | Recruiting | Calgary | Alberta | T2N 4N1 | Canada |
| British Columbia Cancer Agency | Recruiting | Vancouver | British Columbia | V5Z4E6 | Canada |
| Queen Elizabeth II Health Sciences Centre | Recruiting | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Juravinski Cancer Centre | Recruiting | Hamilton | Ontario | L8V5C2 | Canada |
| London Health Sciences Centre | Recruiting | London | Ontario | N6A 5W9 | Canada |
| University Health Network UHN Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
| Peking University People's Hospital | Recruiting | Beijing | 100044 | China |
| First affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | 310003 | China |
| Hotel Dieu CHU de Nantes | Recruiting | Nantes | 44000 | France |
| APHP | Recruiting | Paris | 75012 | France |
| CHU Toulouse | Recruiting | Toulouse | 31300 | France |
| Marien Hospital Dusseldorf | Recruiting | Düsseldorf | 40479 | Germany |
| Universitaetsklinikum Heidelberg | Recruiting | Heidelberg | 69120 | Germany |
| Universitatsklinikum Jena | Recruiting | Jena | 07747 | Germany |
| Universitaetsklinikum Wuerzburg | Recruiting | Würzburg | 97080 | Germany |
| Evangelismos S A | Recruiting | Athens | 106 76 | Greece |
| Alexandra General Hospital of Athens | Recruiting | Athens | 11528 | Greece |
| Theageneio Cancer Hospital | Recruiting | Thessaloniki | 546 39 | Greece |
| Geniko Nosokomeio Thessalonikis George Papanikolaou | Recruiting | Thessaloniki | 570 10 | Greece |
| Soroka Medical Center | Recruiting | Beersheba | 8457108 | Israel |
| Bnai Zion Medical Center | Recruiting | Haifa | 31048 | Israel |
| Rambam Medical Center | Recruiting | Haifa | 3109601 | Israel |
| Carmel Medical Center | Recruiting | Haifa | 34362 | Israel |
| Shaare Zedek MC | Recruiting | Jerusalem | 9103102 | Israel |
| Sheba Medical Center | Recruiting | Ramat Gan | 52621 | Israel |
| Baruch Padeh MC | Recruiting | Ramat Poriya | 1520800 | Israel |
| Assuta MC | Recruiting | Tel Aviv | 69710 | Israel |
| A.O.U. SS. Antonio e Biagio e Cesare Arrigo | Recruiting | Alessandria | 15121 | Italy |
| Spedali Civili di Brescia | Recruiting | Brescia | 25123 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano | Recruiting | Milan | 20122 | Italy |
| Campus Bio Medico di Roma | Recruiting | Roma | 00128 | Italy |
| Fondazione Policlinico Universitario A Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
| Humanitas Hospital | Recruiting | Rozzano | 20089 | Italy |
| Casa Sollievo Della Sofferenza IRCCS | Recruiting | San Giovanni Rotondo | 71013 | Italy |
| U.O. Ematologia Ospedale San Bortolo | Recruiting | Vicenza | 36100 | Italy |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital | Recruiting | Bunkyō City | 113 8677 | Japan |
| Chiba Cancer Center | Recruiting | Chiba | 260 0801 | Japan |
| Shonan Kamakura General Hospital | Recruiting | Kamakura-shi | 247-8533 | Japan |
| Kameda Medical Center | Recruiting | Kamogawa | 296-8602 | Japan |
| Yamanashi Prefectural Central Hospital | Recruiting | Kofu | 400-0027 | Japan |
| The Jikei University Hospital | Recruiting | Minato | 105-8471 | Japan |
| Japanese Red Cross Medical Center | Recruiting | Shibuya City | 150-8935 | Japan |
| Kanagawa Cancer Center | Recruiting | Yokohama | 241 8515 | Japan |
| VU Medisch Centrum | Recruiting | Amsterdam | 1081 HV | Netherlands |
| Universitair Medisch Centrum Groningen | Recruiting | Groningen | 9713 GZ | Netherlands |
| St. Antonius Ziekenhuis Nieuwegein | Recruiting | Nieuwegein | 3435 CM | Netherlands |
| Radboud Umcn | Recruiting | Nijmegen | 6525 GA | Netherlands |
| Erasmus MC | Recruiting | Rotterdam | 3015 | Netherlands |
| Haga ziekenhuis | Recruiting | The Hague | 2545 AA | Netherlands |
| Akershus Universitetssykehus | Recruiting | Lorenskog | 1478 | Norway |
| Oslo University Hospital HF Ulleval sykehus | Recruiting | Oslo | 0450 | Norway |
| Stavanger University Hospital Ullandhaug | Recruiting | Stavanger | 4021 | Norway |
| St. Olavs Hospital | Recruiting | Trondheim | 7030 | Norway |
| Hosp. Univ. Germans Trias I Pujol | Recruiting | Badalona | 08916 | Spain |
| Hosp. Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hosp. Univ. Virgen de Las Nieves | Recruiting | Granada | 18014 | Spain |
| Hosp. Univ. 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hosp Clinico Univ de Salamanca | Recruiting | Salamanca | 37007 | Spain |
| Hosp. Univ. I Politecni La Fe | Recruiting | Valencia | 46026 | Spain |
| Kent and Canterbury Hospital | Recruiting | Canterbury | CT1 3NG | United Kingdom |
| Cardiff and Vale UHB - University Hospital of Wales | Recruiting | Cardiff | CF14 4XW | United Kingdom |
| Ninewells Hospital & Medical School | Recruiting | Dundee | DD1 9SY | United Kingdom |
| University College London Hospitals | Recruiting | London | NW1 2PG | United Kingdom |
| Nottingham City Hospital | Recruiting | Nottingham | NG5 1PB | United Kingdom |
| Queen Alexandra Hospital | Recruiting | Portsmouth | PO6 3LY | United Kingdom |
| Royal Marsden Hospital | Recruiting | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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