Lenalidomide と Pomalidomide と Daratumumab で多発性骨髄腫と免疫グロブリン軽鎖アミロイドーシスとくすぶっている多発性骨髄腫-臨床試験登録-ICH GCP

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

276

段階

フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Study Contact
電話番号：844-434-4210
メール：Participate-In-This-Study1@its.jnj.com

研究場所

アメリカ
- Colorado
  - Denver、Colorado、アメリカ、80218
    - 募集
    - Colorado Blood Cancer Institute
- Georgia
  - Atlanta、Georgia、アメリカ、30322
    - 募集
    - Winship Cancer Institute Emory University
イスラエル
- - Haifa、イスラエル、3436212
    - 募集
    - Carmel Medical Center
  - Jerusalem、イスラエル、9112001
    - 募集
    - Hadassah Medical Center
  - Ramat Gan、イスラエル、52621
    - 募集
    - Sheba Medical Center
  - Tel Aviv、イスラエル、64239
    - 募集
    - Tel Aviv Sourasky Medical Center
オランダ
- - Amsterdam、オランダ、1081 HV
    - 募集
    - VU Medisch Centrum
  - Groningen、オランダ、9713 GZ
    - 募集
    - Universitair Medisch Centrum Groningen
  - Utrecht、オランダ、3584 CX
    - 募集
    - UMC Utrecht
オーストラリア
- - Clayton、オーストラリア、3168
    - 募集
    - Monash Medical Centre
  - Fitzroy、オーストラリア、3065
    - 募集
    - St Vincents Hospital Melbourne
  - Melbourne、オーストラリア、3000
    - 募集
    - Peter MacCallum Cancer Centre
  - Waratah、オーストラリア、2298
    - 募集
    - Calvary Mater Newcastle Hospital
  - Wollongong、オーストラリア、2500
    - 募集
    - Wollongong Hospital
スペイン
- - Barcelona、スペイン、08036
    - 募集
    - Hosp. Clinic de Barcelona
  - Salamanca、スペイン、37007
    - 募集
    - Hosp Clinico Univ de Salamanca

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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 (%)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

主な目的：処理
割り当て：非ランダム化
介入モデル：順次割り当て
マスキング：なし（オープンラベル）

アーム数

5

武器と介入

参加者グループ / アーム	介入・治療
実験的：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.	薬：Daratumumab Daratumumab will be administered subcutaneously. 薬：JNJ-79635322 JNJ-79635322 will be administered subcutaneously.
実験的：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.	薬：Pomalidomide Pomalidomide will be administered orally. 薬：JNJ-79635322 JNJ-79635322 will be administered subcutaneously.
実験的：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.	薬：Lenalidomide Lenalidomide will be administered orally. 薬：Daratumumab Daratumumab will be administered subcutaneously. 薬：JNJ-79635322 JNJ-79635322 will be administered subcutaneously.
実験的：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.	薬：Daratumumab Daratumumab will be administered subcutaneously. 薬：JNJ-79635322 JNJ-79635322 will be administered subcutaneously.
実験的：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.	薬：Daratumumab Daratumumab will be administered subcutaneously. 薬：JNJ-79635322 JNJ-79635322 will be administered subcutaneously.

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Part 1: Number of Participants with Dose-limiting Toxicity (DLT) 時間枠：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 時間枠：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 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Percentage of Participants With Overall Response Rate 時間枠：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 時間枠：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 時間枠：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 時間枠：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) 時間枠：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) 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Janssen Research & Development, LLC

捜査官

スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

Pillarisetti K, Yang D, Luistro L, Yao J, Smith M, Vulfson P, Testa JS, Ponticiello R, Brodeur S, Heidrich B, Packman K, Singh S, Attar R, Elsayed Y, Philippar U. Ramantamig (JNJ-79635322), a novel T-cell-engaging trispecific antibody targeting BCMA, GPRC5D, and CD3, in multiple myeloma models. Blood. 2026 Feb 19;147(8):834-847. doi: 10.1182/blood.2025030027.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年12月4日

一次修了 (推定)

2029年1月2日

研究の完了 (推定)

2029年6月29日

試験登録日

最初に提出

2024年12月23日

QC基準を満たした最初の提出物

2025年1月9日

最初の投稿 (実際)

2025年1月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月25日

QC基準を満たした最後の更新が送信されました

2026年9月24日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

79635322MMY1002
2024-515316-44-00 (レジストリ識別子：EUCT number)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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

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

調査の概要

状態

条件

介入・治療

研究の種類

入学 (推定)

段階

連絡先と場所

研究連絡先

研究場所

参加基準

適格基準

就学可能な年齢

健康ボランティアの受け入れ

受講資格のある性別

説明

研究計画

研究はどのように設計されていますか？

デザインの詳細

アーム数

武器と介入

参加者グループ / アーム

介入・治療

この研究は何を測定していますか？

主要な結果の測定

結果測定

メジャーの説明

時間枠

二次結果の測定

結果測定

メジャーの説明

時間枠

協力者と研究者

スポンサー

捜査官

出版物と役立つリンク

一般刊行物

研究記録日

主要日程の研究

研究開始 (実際)

一次修了 (推定)

研究の完了 (推定)

試験登録日

最初に提出

QC基準を満たした最初の提出物

最初の投稿 (実際)

学習記録の更新

投稿された最後の更新 (実際)

QC基準を満たした最後の更新が送信されました

最終確認日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

IPD プランの説明

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

米国FDA規制機器製品の研究

米国で製造され、米国から輸出された製品。