Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or JNJ-79635322 in Combination With Pomalidomide for Multiple Myeloma

24 сентября 2026 г. обновлено: Janssen Research & Development, LLC

A Phase 1b Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or in Combination With Pomalidomide for Multiple Myeloma

The primary purpose of this study for Part 1 (Dose Escalation) is to identify the safe effective dose (recommended Phase 2 doses [RP2Ds]) and schedule for JNJ-79635322 treatment regimen in combination with daratumumab with or without lenalidomide or with pomalidomide; and for Part 2 (Dose Expansion) is to further characterize the safety and tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

276

Фаза

  • Фаза 1

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Места учебы

  • Австралия
      • Clayton, Австралия, 3168
        • Рекрутинг
        • Monash Medical Centre
      • Fitzroy, Австралия, 3065
        • Рекрутинг
        • St Vincents Hospital Melbourne
      • Melbourne, Австралия, 3000
        • Рекрутинг
        • Peter MacCallum Cancer Centre
      • Waratah, Австралия, 2298
        • Рекрутинг
        • Calvary Mater Newcastle Hospital
      • Wollongong, Австралия, 2500
        • Рекрутинг
        • Wollongong Hospital
  • Израиль
      • Haifa, Израиль, 3436212
        • Рекрутинг
        • Carmel Medical Center
      • Jerusalem, Израиль, 9112001
        • Рекрутинг
        • Hadassah Medical Center
      • Ramat Gan, Израиль, 52621
        • Рекрутинг
        • Sheba Medical Center
      • Tel Aviv, Израиль, 64239
        • Рекрутинг
        • Tel Aviv Sourasky Medical Center
  • Испания
      • Barcelona, Испания, 08036
        • Рекрутинг
        • Hosp. Clinic de Barcelona
      • Salamanca, Испания, 37007
        • Рекрутинг
        • Hosp Clinico Univ de Salamanca
  • Нидерланды
      • Amsterdam, Нидерланды, 1081 HV
        • Рекрутинг
        • VU Medisch Centrum
      • Groningen, Нидерланды, 9713 GZ
        • Рекрутинг
        • Universitair Medisch Centrum Groningen
      • Utrecht, Нидерланды, 3584 CX
        • Рекрутинг
        • UMC Utrecht
  • Соединенные Штаты
    • Colorado
      • Denver, Colorado, Соединенные Штаты, 80218
        • Рекрутинг
        • Colorado Blood Cancer Institute
    • Georgia
      • Atlanta, Georgia, Соединенные Штаты, 30322
        • Рекрутинг
        • Winship Cancer Institute Emory University

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria for newly diagnosed multiple myeloma (NDMM) and relapsed or refractory multiple myeloma (R/R MM):

  • Have documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria
  • Meet treatment regimen-specific requirements as follows: Treatment regimen A (JNJ-79635322+daratumumab):Treatment regimens A1 and A3: Have been treated with 1 to 3 prior lines of therapy, including a proteasome inhibitor (PI) and an inhibitor, immunomodulatory drug (IMiD) therapy for the treatment of multiple myeloma (MM); Treatment regimens A2 and A4: Newly diagnosed MM naïve to multiple myeloma (or other related plasma cell neoplasm)-directed treatments; Treatment regimen B (JNJ-79635322+pomalidomide): Have received greater than or equal to (>=) 1 prior line of therapy, including a PI and lenalidomide, and are lenalidomide refractory OR >=2 prior lines of therapy, including a PI and lenalidomide; Treatment Regimens C, D, and E: Newly diagnosed MM naïve to multiple myeloma (or other related plasma cell neoplasm)-directed treatments
  • Have a weight >=40 kilograms
  • Must have an Eastern Cooperative Oncology Group status of 0 or 2
  • Have measurable disease at screening as defined by at least 1 of the following: a) Serum monoclonal protein (M-protein) level >= 0.5 gram per deciliter (g/dL); or b) Urine M-protein level >=200 milligram (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal serum Ig kappa lambda FLC ratio. d) For participants without measurable disease in the serum, urine, or involved FLC: presence of 1 or more focus of extramedullary disease which meets the following criteria: extramedullary plasmacytoma not contiguous with a bone lesion, at least 1 lesion >=2 centimeter (cm) (at its greatest dimension) diameter on whole body positron emission tomography-computed tomography (or whole-body magnetic resonance imaging approved by sponsor), and not previously radiated

Inclusion criteria for newly diagnosed amyloid light chain (ND AL) Amyloidosis

  • Have a histopathological diagnosis of amyloidosis
  • Have an ECOG performance status of 0 to 1

Inclusion criteria for High-risk smoldering multiple myeloma (SMM)

  • Have a diagnosis of SMM (per IMWG criteria) for less than or equal to (<=) 5 years with measurable disease at the time of enrollment as defined in the protocol
  • Have an ECOG performance status of 0 to 1

Exclusion Criteria for NDMM and R/R MM:

  • Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: a) Targeted therapy, epigenetic therapy, monoclonal antibody (mAb) treatment, or treatment with an investigational drug or an invasive investigational medical device within 21 days or 5 half-lives, whichever is less. b) Gene-modified adoptive cell therapy (example, chimeric antigen receptor [CAR] modified T cells, natural killer cells) within 90 days. c) Prior anti-CD38 directed therapy within 90 days (for treatment regimens A, C, D and E only; within 21 days for treatment regimen B). d) Conventional chemotherapy within 21 days. e) PI therapy within 14 days. f) Immunomodulatory agent therapy within 7 days. g) Radiotherapy within 14 days
  • Stem cell transplantation: a) Allogeneic stem cell transplant within 6 months before the first dose of study treatment. b) Received an autologous stem cell transplant <=12 weeks before the first dose of study treatment
  • Nonhematologic toxicity from prior anticancer therapy that has not resolved to baseline level or to grade <=1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy grade <=3)
  • Prior treatment with CD3-redirecting therapy

Exclusion Criteria for ND AL Amyloidosis

  • Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, >=60 percent (%) plasma cells in the bone marrow, or hypercalcemia
  • Macroglossia that impairs swallowing difficulty
  • Prior therapy for AL amyloidosis or multiple myeloma

Exclusion Criteria for High-risk SMM

  • Multiple myeloma, requiring treatment
  • Primary systemic AL (immunoglobulin light chain) amyloidosis

Exclusion criteria for all participants:

  • Any serious underlying medical conditions, such as: Evidence of active viral, bacterial, or systemic fungal infection requiring ongoing antiviral, antibacterial, or antifungal treatment; active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment; cardiovascular dysfunction; pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation; human immunodeficiency (HIV) infection; active hepatitis B or C infection; stroke or seizure within 6 months prior to first dose of study treatment
  • Known or suspected chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than (<) 50 percent (%)

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Нерандомизированный
  • Интервенционная модель: Последовательное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Treatment Regimen A and C: JNJ-79635322+Daratumumab

Participants who have received 1-3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) (Treatment regimen A1 and A3) will receive JNJ-79635322 along with daratumumab to establish the recommended phase 2 doses (RP2D[s]) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Based on the study evaluation team (SET) decision, enrollment may proceed in participants with newly diagnosed multiple myeloma (NDMM) (Treatment regimens A2, A4 and C). Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Лекарство: Daratumumab

Daratumumab will be administered subcutaneously.

Лекарство: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.
Экспериментальный: Treatment Regimen B: JNJ-79635322+Pomalidomide

Participants who have received greater than or equal to (>=)1 prior line of therapy, including a PI and lenalidomide, and are lenalidomide refractory or >=2 prior lines of therapy, including a PI and lenalidomide will receive JNJ-79635322 along with pomalidomide to establish the RP2D(s) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Лекарство: Pomalidomide

Pomalidomide will be administered orally.

Лекарство: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.
Экспериментальный: Treatment Regimen D and E: JNJ-79635322 + Daratumumab + Lenalidomide Combination

Participants with NDMM will receive JNJ-79635322 along with daratumumab and lenalidomide to establish the RP2D[s] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Лекарство: Lenalidomide

Lenalidomide will be administered orally.

Лекарство: Daratumumab

Daratumumab will be administered subcutaneously.

Лекарство: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.
Экспериментальный: Treatment Regimen F: JNJ-79635322 + Daratumumab

Participants with newly diagnosed amyloid light chain (ND AL) amyloidosis will receive JNJ-79635322 in treatment regimen F along with daratumumab to establish the RP2D[s] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 and daratumumab at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Лекарство: Daratumumab

Daratumumab will be administered subcutaneously.

Лекарство: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.
Экспериментальный: Treatment Regimen G: JNJ-79635322 + Daratumumab

Participants with high-risk smoldering multiple myeloma (SMM) will receive JNJ-79635322 in treatment regimen G along with daratumumab to establish the RP2D[s] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 and daratumumab at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Лекарство: Daratumumab

Daratumumab will be administered subcutaneously.

Лекарство: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
Временное ограничение: Up to 28 days

DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Up to 28 days
Number of Participants with Adverse Events (AEs) by Severity
Временное ограничение: Up to 3 Years and 3 months

An AE is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0. 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.
Up to 3 Years and 3 months
Number of Participants with Clinically Significant Laboratory Abnormalities
Временное ограничение: Up to 3 Years and 3 months

Participants with clinically significant laboratory abnormalities (hematology and chemistry) will be reported.
Up to 3 Years and 3 months

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants With Overall Response Rate
Временное ограничение: Up to 3 Years and 3 months

Overall response rate is defined as percentage of participants with newly diagnosed multiple myeloma (NDMM), relapsed or refractory multiple myeloma (R/R MM), or high-risk smoldering multiple myeloma (SMM) who have a partial response (PR) or better evaluated by the investigator as per international myeloma working group (IMWG) 2016 criteria.
Up to 3 Years and 3 months
Percentage of Participants With Very Good Partial Response (VGPR) or Better Response Rate
Временное ограничение: Up to 3 Years and 3 months

VGPR or better response rate is defined as the percentage of participants with NDMM, R/R MM, or high-risk SMM who achieve a VGPR or better response (stringent complete response [sCR]+ complete response [CR]+VGPR) according to the IMWG 2016 criteria.
Up to 3 Years and 3 months
Percentage of Participants With CR or Better Response Rate
Временное ограничение: Up to 3 Years and 3 months

CR or better response rate is defined as the percentage of participants with NDMM R/R MM, or high-risk SMM who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.
Up to 3 Years and 3 months
Percentage of Participants With sCR or Better Response Rate
Временное ограничение: Up to 3 Years and 3 months

sCR rate is defined as the percentage of participants with NDMM R/R MM, or high-risk SMM who achieve an sCR according to the IMWG 2016 criteria.
Up to 3 Years and 3 months
Duration of Response (DOR)
Временное ограничение: Up to 3 Years and 3 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), as per IMWG 2016 response criteria, or death due to progression, whichever occurs first in participants with NDMM, R/R MM, or high-risk SMM.
Up to 3 Years and 3 months
Time to Response (TTR)
Временное ограничение: Up to 3 Years and 3 months

TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participants with NDMM, R/R MM, or high-risk SMM has met all criteria for PR or better as defined by IMWG 2016 response criteria.
Up to 3 Years and 3 months
Percentage of Participants With Hematologic Response As Defined by International Amyloidosis Consensus Criteria
Временное ограничение: Up to 3 Years and 3 months

Hematologic response is defined as percentage of participants with newly diagnosed amyloid light chain (ND AL) amyloidosis who achieve complete response, very good partial response, partial response, no response and progression as defined by International amyloidosis consensus criteria present in the protocol will be reported.
Up to 3 Years and 3 months
DOR as Defined by International Amyloidosis Consensus Criteria
Временное ограничение: Up to 3 Years and 3 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), as per International amyloidosis consensus criteria, or death due to progression, whichever occurs first in participants with ND AL amyloidosis.
Up to 3 Years and 3 months
TTR as Defined by International Amyloidosis Consensus Criteria
Временное ограничение: Up to 3 Years and 3 months

TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant with ND AL amyloidosis has met all criteria for PR or better as defined by International amyloidosis consensus criteria.
Up to 3 Years and 3 months
Serum Concentration of JNJ-79635322 and Daratumumab
Временное ограничение: Up to 3 Years and 3 months

Serum samples will be analyzed to determine concentrations of JNJ-79635322 and daratumumab.
Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUCinf) for JNJ-79635322 and Daratumumab
Временное ограничение: Up to 3 Years and 3 months

AUCinf for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve from Time Zero to the Last Measurable Concentration [AUC(0-t)] for JNJ-79635322 and Daratumumab
Временное ограничение: Up to 3 Years and 3 months

AUC(0-t) for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve During the Dosing Interval (AUCtau) for JNJ-79635322 and Daratumumab
Временное ограничение: Up to 3 Years and 3 months

AUCtau for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Maximum Serum Concentration (Cmax) for JNJ-79635322 and Daratumumab
Временное ограничение: Up to 3 Years and 3 months

Cmax for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Half Life (T1/2) for JNJ-79635322 and Daratumumab
Временное ограничение: Up to 3 Years and 3 months

T1/2 for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Time to Reach Cmax (Tmax) for JNJ-79635322 and Daratumumab
Временное ограничение: Up to 3 Years and 3 months

Tmax for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Systemic Clearance (CL/F) for JNJ-79635322 and Daratumumab
Временное ограничение: Up to 3 Years and 3 months

CL/F for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Apparent Volume of Distribution at Steady State (Vss/F) for JNJ-79635322 and Daratumumab
Временное ограничение: Up to 3 Years and 3 months

Vss/F for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322 and Daratumumab
Временное ограничение: Up to 3 Years and 3 months

Participants with anti-drug antibodies to JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Janssen Research & Development, LLC

Следователи

  • Директор по исследованиям: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

4 декабря 2024 г.

Первичное завершение (Оцененный)

2 января 2029 г.

Завершение исследования (Оцененный)

29 июня 2029 г.

Даты регистрации исследования

Первый отправленный

23 декабря 2024 г.

Впервые представлено, что соответствует критериям контроля качества

9 января 2025 г.

Первый опубликованный (Действительный)

10 января 2025 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

25 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

24 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 79635322MMY1002
  • 2024-515316-44-00 (Идентификатор реестра: EUCT number)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

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

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Да

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться