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| ID | Type | Description | Link |
|---|---|---|---|
| 79635322MMY2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2025-521976-80-00 | Registry Identifier | EUCT number |
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The purpose of this study is to evaluate how well JNJ-79635322 works (efficacy) in participants with Relapsed or Refractory Multiple Myeloma (RRMM; a cancer that forms in a type of white blood cells called a plasma cell. Cancer is called relapsed if it comes back after treatment and is called 'refractory' if does not respond to treatment) who have received at least 3 prior lines of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-79635322 | Experimental | Participants will receive JNJ-79635322 as an injection under the skin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-79635322 | Drug | JNJ-79635322 will be administered as an injection under the skin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Up to 2 years and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Very Good Partial Response (VGPR) or Better Rate | Up to 2 years and 9 months | |
| Complete Response (CR) or Better Rate | Up to 2 years and 9 months | |
| Duration of Response (DoR) |
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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 monoclonal antibody (mAb)
Documented evidence of progressive disease(PD) or failure to achieve a response to the last line of therapy based on investigator's determination of response by the 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 (PS) 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 |
|---|---|---|---|---|---|---|
| O Neal Comprehensive Cancer Center at UAB | Recruiting | Birmingham | Alabama | 35294 | 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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| Up to 2 years and 9 months |
| Progression-Free Survival (PFS) | Up to 2 years and 9 months |
| Overall Survival (OS) | Up to 2 years and 9 months |
| Time To Next Line of Therapy (TTNT) | Up to 2 years and 9 months |
| Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity | Up to 2 years and 9 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) Scale Score | From Baseline up to 2 years and 9 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) Scale Score | From Baseline up to 2 years and 9 months |
| Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Score | From Baseline up to 2 years and 9 months |
| Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q | Up to 2 years and 9 months |
| Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 | Up to 2 years and 9 months |
| Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L | Up to 2 years and 9 months |
| Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q | Up to 2 years and 9 months |
| Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 | Up to 2 years and 9 months |
| Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L | Up to 2 years and 9 months |
| Serum Concentrations for JNJ-79635322 | Up to 2 years and 9 months |
| Number of Participants With Anti JNJ-79635322 Antibodies | Up to 2 years and 9 months |
| Number of Participants With JNJ-79635322 Neutralizing Antibodies (NAb) | Up to 2 years and 9 months |
| Banner MD Anderson Cancer Center |
| Recruiting |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
| City of Hope Orange County Lennar Foundation Cancer Center | Recruiting | Irvine | California | 92618 | United States |
| Cancer and Blood Specialty Clinic | Recruiting | Los Alamitos | California | 90720 | United States |
| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States |
| Rocky Mountain Cancer Centers | Recruiting | Aurora | Colorado | 80012 | United States |
| Colorado Blood Cancer Institute | Recruiting | Denver | Colorado | 80218 | United States |
| Cancer Specialists of North Florida | Recruiting | Jacksonville | Florida | 32256 | United States |
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
| Northside Hospital Cancer Institute | Recruiting | Atlanta | Georgia | 30342 | United States |
| Cancer Care Specialists of Central Illinois | Recruiting | O'Fallon | Illinois | 62269 | United States |
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
| Mission Cancer Blood | Recruiting | Waukee | Iowa | 50263 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Rutgers Cancer Institute | Recruiting | New Brunswick | New Jersey | 08901 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| Cleveland Clinic Foundtation | Recruiting | Cleveland | Ohio | 44195 | United States |
| Oncology Associates of Oregon PC Willamette Valley Cancer Institute | Recruiting | Eugene | Oregon | 97401 | United States |
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| Tennessee Oncology, PLLC | Recruiting | Nashville | Tennessee | 37203 | United States |
| Texas Oncology | Recruiting | Austin | Texas | 78705 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Oncology Consultants Texas | Recruiting | Houston | Texas | 77030 | United States |
| Texas Oncology - Northeast | Recruiting | Tyler | Texas | 75702 | United States |
| Virginia Cancer Specialists | Recruiting | Fairfax | Virginia | 22031 | United States |
| Virginia Oncology Associates | Recruiting | Norfolk | Virginia | 23502 | United States |
| NorthWest Medical Specialties, PLLC | Recruiting | Tacoma | Washington | 98405 | United States |
| Peking Union Medical College Hospital | Recruiting | Beijing | 100006 | China |
| Beijing Chaoyang Hospital | Recruiting | Chaoyang District | 100020 | China |
| Sun Yat Sen University Cancer Center | Recruiting | Guangzhou | 510700 | China |
| Shanghai Fourth People s Hospital | Recruiting | Shanghai | 200434 | China |
| Ha'Emek Medical Center | Recruiting | Afula | 1834111 | Israel |
| Samson Assuta Ashdod University Hospital | Recruiting | Ashdod | 7747629 | Israel |
| Hillel Yaffe Medical Center | Recruiting | Hadera | 3820302 | Israel |
| Hadassah Medical Center | Recruiting | Jerusalem | 9112000 | Israel |
| Rabin Medical Center | Recruiting | Petah Tikva | 4941492 | Israel |
| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 6423906 | Israel |
| ASST Papa Giovanni XXIII Bergamo | Recruiting | Bergamo | 24127 | Italy |
| Azienda Ospedaliera S Croce e Carle Cuneo | Recruiting | Cuneo | 12100 | Italy |
| Azienda Ospedaliero Universitaria Careggi | Recruiting | Florence | 50134 | Italy |
| Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone | Recruiting | Palermo | 90127 | Italy |
| IRCCS Policlinico San Matteo, Università degli studi di Pavi | Recruiting | Pavia | 27100 | Italy |
| Presidio Ospedaliero Pescara | Recruiting | Pescara | 65124 | Italy |
| AOU Policlinico Umberto I | Recruiting | Roma | 00161 | Italy |
| Centro Ricerche Cliniche di Verona S r l | Recruiting | Verona | 37134 | Italy |
| National Hospital Organization Shibukawa Medical Center | Recruiting | Gunma | 377-0280 | Japan |
| National Hospital Organization Okayama Medical Center | Recruiting | Okayama | 701-1192 | Japan |
| Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza | Recruiting | Brzozów | 36 200 | Poland |
| Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach | Recruiting | Kielce | 25 734 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie | Recruiting | Krakow | 30 688 | Poland |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi | Recruiting | Lodz | 93 513 | Poland |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie | Recruiting | Lublin | 20 081 | Poland |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Recruiting | Poznan | 60-569 | Poland |
| Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu | Recruiting | Torun | 87 100 | Poland |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu | Recruiting | Wroclaw | 50 367 | Poland |
| Chonnam National University Hwasun Hospital | Recruiting | Jeollanam-do | 58128 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St Marys Hospital | Recruiting | Seoul | 06591 | South Korea |
| Ankara University Medical Faculty | Recruiting | Ankara | 06590 | Turkey (Türkiye) |
| Liv Hospital Ankara | Recruiting | Ankara | 06680 | Turkey (Türkiye) |
| Memorial Antalya Hospital | Recruiting | Antalya | 07025 | Turkey (Türkiye) |
| Medipol University Hospital | Recruiting | Istanbul | 34214 | Turkey (Türkiye) |
| Istanbul Florance Nightingale Hospital | Recruiting | Istanbul | 34381 | Turkey (Türkiye) |
| Sakarya Üniversitesi Tıp Fakültesi Hastanesi | Recruiting | Sakarya | 54050 | 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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