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The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: JNJ-79635322 | Experimental | Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first). |
|
| Arm B: Teclistamab | Active Comparator | Participants will receive teclistamab 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 |
|---|---|---|
| Complete Response (CR) or Better | CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria during or after the study treatment. | Up to approximately 41 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 approximately 41 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve partial response (PR) or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria. | Up to approximately 41 months |
| Very Good Partial Response (VGPR) or Better |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Recruiting | Springdale | Arkansas | 72762 | United States | |
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. |
|
VGPR or better is defined as the percentage of participants achieving VGPR, CR, or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. |
| Up to approximately 41 months |
| Duration of Response (DoR) | DoR is defined as the time interval between the date of initial documentation of a 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 approximately 41 months |
| Minimal Residual Disease (MRD)-negative CR | MRD-negative CR is defined as the percentage of participants with CR or better 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. | Up to approximately 41 months |
| MRD-negative CR at 1 Year | MRD-negative CR at 1 year is defined as the percentage of participants who achieve MRD-negative status at 12 months as determined by NGF, prior to PD or subsequent antimyeloma therapy and who also achieve CR or better according to IMWG criteria. | At 1 Year |
| MRD-negative CR at 5 Years | MRD-negative CR at 5 years is defined as the percentage of participants who achieve MRD-negative status at 5 years as determined by NGF, prior to PD or subsequent antimyeloma therapy and who also achieve CR or better according to IMWG criteria. | At 5 Years |
| 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 approximately 41 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 approximately 41 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 approximately 41 months |
| Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. 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 will be considered treatment-related regardless of the start date of the event. 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, Grade 5= death related to adverse event. | Up to approximately 41 months |
| Number of Participants with Abnormalities in Laboratory Parameters | Number of participants with abnormalities in laboratory parameters (serum chemistry, hematology, and urinalysis) will be reported. | Up to approximately 41 months |
| Change from Baseline in Health-related Quality of Life (HRQoL), Symptoms and Functioning using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Scores | Change from baseline in HRQoL, symptoms and functioning as assessed by 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. | From Baseline up to approximately 41 months |
| Change from Baseline in HRQoL, Symptoms and Functioning Using the European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Scores | Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported. | From Baseline up to approximately 41 months |
| Change from Baseline in HRQoL, Symptoms and Functioning Using the European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Scores | 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. | From Baseline up to approximately 41 months |
| Time to Worsening in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores | Time to worsening in HRQoL, symptoms and functioning using the MySIm-Q scale scores will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment with established content validity for participants with RRMM and newly diagnosed MM. | Up to approximately 41 months |
| Time to Worsening in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores | Time to worsening in HRQoL, symptoms and functioning using the EORTC-QLQ-C30 score will be reported. | Up to approximately 41 months |
| Time to Worsening in HRQoL, Symptoms and Functioning using the EQ-5D-5L Scale Scores | 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 approximately 41 months |
| Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores | The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM. | Up to approximately 41 months |
| Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores | Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported. | Up to approximately 41 months |
| Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EQ-5D-5L Scale Scores | 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 approximately 41 months |
| Percentage of Participants who Report Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List (EORTC IL) 46 | The EORTC IL46 consists of one single question that measures global impression of burden due to treatment-related symptoms. The response options range from "not at all" to "very much" on a 4-point scale. | Up to approximately 41 months |
| Valkyrie Clinical Trials |
| Recruiting |
| Los Angeles |
| California |
| 90067 |
| United States |
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
| Nebraska Cancer Specialists | Recruiting | Omaha | Nebraska | 68130 | United States |
| Astera Cancer Care | Recruiting | East Brunswick | New Jersey | 08816 | United States |
| Christus St. Vincent Regional Cancer Center | Recruiting | Santa Fe | New Mexico | 87505 | United States |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island | Recruiting | Mineola | New York | 11501 | United States |
| Laura and Isaac Perlmutter Cancer Center NYU ACC | Recruiting | New York | New York | 10016 | United States |
| New York Cancer and Blood Specialists | Recruiting | Shirley | New York | 11967 | United States |
| Gabrail Cancer Center | Recruiting | Canton | Ohio | 44718 | United States |
| The Christ Hospital | Recruiting | Cincinnati | Ohio | 45069 | United States |
| St Vincent s Hospital Sydney | Recruiting | Darlinghurst | 2010 | Australia |
| Rambam Med.Center - Hematology Institute | Recruiting | Haifa | 3109601 | Israel |
| Carmel Medical Center | Recruiting | Haifa | 3436212 | Israel |
| Rabin Medical Center | Recruiting | Petah Tikva | 4941492 | Israel |
| Sheba Medical Center | Recruiting | Ramat Gan | 5266202 | Israel |
| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 6423906 | Israel |
| Matsuyama Red Cross Hospital | Recruiting | Matsuyama | 790-8524 | Japan |
| National Hospital Organization Okayama Medical Center | Recruiting | Okayama | 701-1192 | Japan |
| The Cancer Institute Hospital of JFCR | Recruiting | Tokyo | 135-8550 | Japan |
| Kanagawa Cancer Center | Recruiting | Yokohama | 241 8515 | Japan |
| China Medical University Hospital | Recruiting | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Recruiting | Taichung | 40705 | Taiwan |
| Taipei Veterans General Hospital | Recruiting | Taipei | 112 | Taiwan |
| Liv Hospital Ankara | Recruiting | Ankara | 06680 | Turkey (Türkiye) |
| Memorial Antalya Hospital | Recruiting | Antalya | 07025 | Turkey (Türkiye) |
| Medipol Mega University Hospital | Recruiting | Istanbul | 34214 | Turkey (Türkiye) |
| Istanbul Florance Nightingale Hospital | Recruiting | Istanbul | 34381 | Turkey (Türkiye) |
| Ondokuz Mayis University | Recruiting | Samsun | 55420 | Turkey (Türkiye) |
| 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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