재발성 또는 불응성 다발성 골수종 환자의 JNJ-79635322 연구
재발성 또는 불응성 다발성 골수종 환자를 대상으로 삼중특이성 항체 JNJ-79635322의 임상 1상, 인간 최초, 용량 증량 연구
The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Study Contact
- 전화번호: 844-434-4210
- 이메일: Participate-In-This-Study1@its.jnj.com
연구 장소
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Amsterdam, 네덜란드, 1081 HV
- 모병
- VUMC Amsterdam
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Groningen, 네덜란드, 9713 GZ
- 모병
- Universitair Medisch Centrum Groningen
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Utrecht, 네덜란드, 3584 CX
- 모병
- UMC Utrecht
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California
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Duarte, California, 미국, 91010
- 모병
- City of Hope
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Irvine, California, 미국, 92618
- 모병
- City of Hope Orange County Lennar Foundation Cancer Center
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San Francisco, California, 미국, 94143
- 모병
- University of California San Francisco
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Colorado
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Denver, Colorado, 미국, 80218
- 모병
- Colorado Blood Cancer Institute
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New York
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New York, New York, 미국, 10065
- 모병
- Memorial Sloan Kettering Cancer Center
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New York, New York, 미국, 10029
- 모병
- Icahn School of Medicine at Mt. Sinai
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North Carolina
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Charlotte, North Carolina, 미국, 28001
- 모병
- Levine Cancer Institute
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- 모병
- University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
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Texas
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Houston, Texas, 미국, 77030
- 모병
- MD Anderson Cancer Center
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Edegem, 벨기에, 2650
- 모병
- UZ Antwerpen
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Ghent, 벨기에, 9000
- 모병
- UZ Gent
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Liège, 벨기에, 4000
- 모병
- CHU de Liege
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Badalona, 스페인, 08916
- 모병
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, 스페인, 08036
- 모병
- Hosp Clinic de Barcelona
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Madrid, 스페인, 28040
- 모병
- Hosp Univ Fund Jimenez Diaz
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Pamplona, 스페인, 31008
- 모병
- Clinica Univ. de Navarra
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Salamanca, 스페인, 37007
- 모병
- Hosp Clinico Univ de Salamanca
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London, 영국, W1T 7HA
- 모병
- University College Hospital
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Sutton, 영국, SM2 5PT
- 모병
- Royal Marsden Hospital
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Shibuya City, 일본, 150-8935
- 모집하지 않고 적극적으로
- Japanese Red Cross Medical Center
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Suita-shi, 일본, 565-0871
- 모집하지 않고 적극적으로
- Osaka University Hospital
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Tokyo, 일본, 135-8550
- 완전한
- The Cancer Institute Hospital of JFCR
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Nantes, 프랑스, 44093
- 모병
- CHU Nantes
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Pierre-Bénite, 프랑스, 69495
- 모병
- CHU Lyon Sud
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Rennes, 프랑스, 35000
- 완전한
- Chu Rennes Hopital Pontchaillou
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Toulouse, 프랑스, 31100
- 모병
- Institut Claudius Regaud
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
For participants with relapsed or refractory multiple myeloma:
- Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Part 1: Have relapsed or refractory disease, have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM),and should have been treated with at least 3 prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, and an anti-CD38-based therapy regardless of prior lines of therapy, Part 2: Have relapsed or refractory disease, have been treated with a PI, IMiD and an anti-CD38 based therapy
- Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); or b) Urine M-protein level >=200 milligrams (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (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 (EMD) 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 and Computed Tomography (PET-CT) Scans (or whole body magnetic resonance imaging [MRI] approved by sponsor), and not previously radiated (Part 2C participants are not required to have measurable disease)
For participants with previously treated AL amyloidosis:
- Initial histopathological diagnosis of amyloidosis
- Participant who is not a candidate for available AL amyloidosis therapy with established clinical benefit and should have received at least 3 cycles of 1 prior line of therapy or a total of at least 2 cycles of 2 or more prior lines of therapy for AL amyloidosis
- Measurable disease at screening defined by at least 1 of the following: serum involved free light chain (iFLC) >=50 mg/L or difference between involved and uninvolved free light chains (dFLC) >=50 mg/L, or serum m-protein >= 0.5 g/dL
- One or more organs impacted by systemic AL amyloidosis
- Left ventricular ejection fraction (LVEF) >=45%
Exclusion Criteria:
For participants with relapsed or refractory multiple myeloma:
- Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
- Received a cumulative dose of corticosteroids equivalent to greater than (>) 140 mg of prednisone within the 14-day period before the start of study treatment administration
- Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days [not applicable for Part 2C participants], or CD3-redirecting therapy within 21 days[not applicable for Part 2B or 2C participants])
- Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
- Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3)
- The following medical conditions: 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, autoimmune disease, serious active viral or bacterial infection, uncontrolled systemic fungal infection, cardiac conditions (myocardial infarction <=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, et cetera)
- Part 2C: have progressive disease or refractory disease per IMWG after CAR-T administration
For participants with previously treated AL amyloidosis:
- CNS involvement or clinical signs of meningeal involvement of AL amyloidosis. If either is suspected, whole brain MRI and lumbar cytology are required
- Any form of non-AL amyloidosis, including but not limited to transthyretin (ATTR) amyloidosis
- Active plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome
- Pulmonary compromise requiring supplemental oxygen use
- Any serious medical conditions such as: active viral, bacterial, fungal infection; active autoimmune disease; HIV infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, significant cardiovascular conditions
- Previous or current diagnosis of symptomatic multiple myeloma
- Macroglossia that impairs swallowing difficulty
- Received a cumulative dose of corticosteroids equivalent to > 140 mg of prednisone within the 14-day period before the start of study treatment administration
- Prior antitumor therapy within 21 days prior to the first dose of study treatment (PI therapy or radiotherapy within 14 days, IMiD agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days, or CD3-redirecting therapy within 21 days)
- Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
- Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to <=1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Part 1: Dose Escalation
Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. |
JNJ-79635322 will be administered as SC injection. |
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실험적: Part 2: Dose Expansion
Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1. |
JNJ-79635322 will be administered as SC injection. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
기간: Up to 2 years 5 months
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DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. |
Up to 2 years 5 months
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Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity
기간: Up to 2 years 5 months
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An adverse event 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 2 years 5 months
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Part 2: Number of Participants with Abnormalities in Laboratory Values
기간: Up to 2 Years 5 months
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Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported. |
Up to 2 Years 5 months
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Serum Concentration of JNJ-79635322
기간: Up to 2 Years 5 months
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Serum samples will be analyzed to determine concentrations of JNJ-79635322. |
Up to 2 Years 5 months
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Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322
기간: Up to 2 Years 5 months
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Number of participants with presence of anti-drug antibodies to JNJ-79635322 will be reported. |
Up to 2 Years 5 months
|
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Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Myeloma Working Group (IMWG) 2016 Response Criteria
기간: Up to 2 Years 5 months
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Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria. |
Up to 2 Years 5 months
|
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Time to Response (TTR) as Defined by IMWG 2016 Response Criteria
기간: Up to 2 Years 5 months
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TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for partial response (PR) or better as defined by IMWG 2016 response criteria. |
Up to 2 Years 5 months
|
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Duration of Response (DOR) as Defined by IMWG 2016 Response Criteria
기간: Up to 2 Years 5 months
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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), per IMWG 2016 response criteria, or death due to any cause, whichever occurs first. |
Up to 2 Years 5 months
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Part 2: Time to Response (TTR) as Defined by International Amyloidosis Consensus Criteria
기간: Up to 2 Years 5 months
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TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for PR or better as defined by International Amyloidosis Consensus Criteria. |
Up to 2 Years 5 months
|
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Part 2: Duration of Response (DOR) as Defined by International Amyloidosis Consensus Criteria
기간: Up to 2 Years 5 months
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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), per International Amyloidosis Consensus Criteria or death due to any cause, whichever occurs first. |
Up to 2 Years 5 months
|
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Part 2: Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Amyloidosis Consensus Criteria
기간: Up to 2 Years 5 months
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Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Amyloidosis Consensus Criteria. |
Up to 2 Years 5 months
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- CR109234
- 2022-001465-12 (EudraCT 번호)
- 79635322MMY1001 (기타 식별자: Janssen Research & Development, LLC)
- 2023-503679-12-00 (레지스트리 식별자: EUCT number)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .