A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma

Официальное название

A Phase 2, Open-label Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody

Обзор

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.

Вмешательства

• Препарат JNJ-79635322
  JNJ-79635322 will be administered as an injection under the skin.

Первичные конечные точки

• Overall Response Rate (ORR) [Срок оценки: Up to 2 years and 9 months]

Вторичные конечные точки (12)

• Very Good Partial Response (VGPR) or Better Rate [Срок оценки: Up to 2 years and 9 months]
• Complete Response (CR) or Better Rate [Срок оценки: Up to 2 years and 9 months]
• Duration of Response (DoR) [Срок оценки: Up to 2 years and 9 months]
• Progression-Free Survival (PFS) [Срок оценки: Up to 2 years and 9 months]
• Overall Survival (OS) [Срок оценки: Up to 2 years and 9 months]
• Time To Next Line of Therapy (TTNT) [Срок оценки: Up to 2 years and 9 months]
• Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From Baseline up to 2 years and 9 months]
• Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q [Срок оценки: Up to 2 years and 9 months]
• Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 [Срок оценки: Up to 2 years and 9 months]

Критерии участия

Inclusion:

• Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:

• MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
• Measurable disease at screening as assessed by central laboratory
• 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:

• Suspected or known allergies, hypersensitivity, or intolerance to excipients of JNJ-79635322
• Had major surgery within 2 weeks before first dose or has planned major surgery during study treatment phase
• Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
• Participant has leptomeningeal disease
• Participant has a prior or concurrent second malignancy the natural history or treatment of which could likely interfere with any study endpoints of safety or the efficacy of the study treatment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 30 центров

• O Neal Comprehensive Cancer Center at UAB — Birmingham
• Banner MD Anderson Cancer Center — Gilbert
• City of Hope — Duarte
• City of Hope Orange County Lennar Foundation Cancer Center — Irvine
• Cancer and Blood Specialty Clinic — Los Alamitos
• University of California San Francisco — San Francisco
• Rocky Mountain Cancer Centers — Aurora
• Colorado Blood Cancer Institute — Denver
• … и ещё 22 центра

Италия · 9 центров

• ASST Papa Giovanni XXIII Bergamo — Bergamo
• Policlinico Sant'Orsola Malpighi — Bologna
• Azienda Ospedaliera S Croce e Carle Cuneo — Cuneo
• Azienda Ospedaliero Universitaria Careggi — Florence
• Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone — Palermo
• IRCCS Policlinico San Matteo, Università degli studi di Pavi — Pavia
• Presidio Ospedaliero Pescara — Pescara
• AOU Policlinico Umberto I — Roma
• … и ещё 1 центр

Польша · 8 центров

• Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza — Brzozów
• Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach — Kielce
• Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie — Krakow
• Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi — Lodz
• Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie — Lublin
• Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan
• Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu — Torun
• Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu — Wroclaw

Израиль · 6 центров

• Ha'Emek Medical Center — Afula
• Samson Assuta Ashdod University Hospital — Ashdod
• Hillel Yaffe Medical Center — Hadera
• Hadassah Medical Center — Jerusalem
• Rabin Medical Center — Petah Tikva
• Tel Aviv Sourasky Medical Center — Tel Aviv

South Korea · 6 центров

• Chonnam National University Hwasun Hospital — Jeollanam-do
• Seoul National University Hospital — Seoul
• Severance Hospital Yonsei University Health System — Seoul
• Asan Medical Center — Seoul
• Samsung Medical Center — Seoul
• The Catholic University of Korea Seoul St Marys Hospital — Seoul

Turkey (Türkiye) · 6 центров

• Ankara University Medical Faculty — Ankara
• Liv Hospital Ankara — Ankara
• Memorial Antalya Hospital — Antalya
• Medipol University Hospital — Istanbul
• Istanbul Florance Nightingale Hospital — Istanbul
• Sakarya Üniversitesi Tıp Fakültesi Hastanesi — Sakarya

Китай · 4 центра

• Peking Union Medical College Hospital — Пекин
• Beijing Chaoyang Hospital — Chaoyang District
• Sun Yat Sen University Cancer Center — Гуанчжоу
• Shanghai Fourth People s Hospital — Шанхай

Япония · 2 центра

• National Hospital Organization Shibukawa Medical Center — Gunma
• National Hospital Organization Okayama Medical Center — Okayama

Идентификаторы

NCT: NCT07266441 · 79635322MMY2001 · 79635322MMY2001 · 2025-521976-80-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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