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A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma (TRI Pro)

2026년 5월 11일 업데이트: Janssen Research & Development, LLC

79635322MMY2002: Phase 2 Randomized, Double-blind, Placebo-controlled Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma

The purpose of this study is to find out whether giving a single dose of tocilizumab before treatment with ramantamig can help prevent or reduce the severity of cytokine release syndrome (CRS) within 28 days from ramantamig, compared to participants who receive placebo. CRS is an acute inflammatory reaction that can occur during treatment and may be associated with flu-like or other systemic symptoms, such as fever and tiredness.

연구 개요

연구 유형

중재적

등록 (추정된)

230

단계

  • 2 단계

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연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

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설명

Inclusion criteria:

  • Documented diagnosis of multiple myeloma (MM) as defined by the criteria: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria; b. Measurable disease at screening as assessed by local laboratory as defined in the protocol
  • Received at least 1 prior lines of antimyeloma therapy
  • Relapsed or refractory disease as defined: a. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by the IMWG response criteria greater than (>) 60 days after cessation of treatment.; b. Refractory disease is defined as failure to achieve a response (that is, partial response or better) or confirmed PD by the IMWG response criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
  • Have an eastern cooperative oncology group (ECOG) performance status (PS) score of 0 to 2 at screening and immediately before the start of study treatment administration. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to MM or associated therapy
  • Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment

Exclusion criteria:

  • Concurrent use of any other anticancer treatment (including non-palliative radiotherapy) or investigational agent
  • Major surgery, (for example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
  • Suspected or known allergies, hypersensitivity, or intolerance to ramantamig and tocilizumab or their excipients
  • Presence of any of the following: a. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); b. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; c. Any active malignancy other than MM that is considered at high risk of recurrence requiring systemic therapy
  • Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

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디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Arm A: Tocilizumab + Ramantamig
Participants will receive tocilizumab alongwith ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until progressive disease (PD) or intolerable toxicity (whichever is earlier).
Ramantamig will be administered as subcutaneous (SC) injection.
다른 이름들:
  • JNJ-79635322
Tocilizumab will be administered as intravenous (IV) injection.
위약 비교기: Arm B: Placebo + Ramantamig
Participants will receive placebo (saline) alongwith ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until PD or intolerable toxicity (whichever is earlier).
Ramantamig will be administered as subcutaneous (SC) injection.
다른 이름들:
  • JNJ-79635322
Placebo (saline) will be administered as IV injection.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Alive and Free of Treatment-Emergent American Society for Transplantation and Cellular Therapy (ASTCT) Grade Greater Than or Equal to (>=) 2 Cytokine Release Syndrome (CRS)
기간: End of Day 28 from ramantamig dose
Percentage of participants alive and free of treatment-emergent ASTCT Grade >=2 CRS without the use of intervening treatment for CRS of any grade by the end of Day 28 from ramantamig dose will be reported.
End of Day 28 from ramantamig dose

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 by the End of Day 28 from Ramantamig Dose
기간: End of Day 28 from ramantamig dose
Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 by the end of Day 28 from the ramantamig dose, respectively, will be reported.
End of Day 28 from ramantamig dose
Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 During Ramantamig Treatment
기간: Up to 37 months
Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 during ramantamig treatment will be reported.
Up to 37 months
Percentage of Participants with Re-occurrence of CRS with ASTCT Grade >=2 After the Initial Occurrence of Treatment-Emergent Grade >=2 CRS Event
기간: Up to approximately 3 years and 6 months
Percentage of participants with re-occurrence of CRS with ASTCT Grade >=2 after the initial occurrence of treatment-emergent Grade >=2 CRS event will be reported.
Up to approximately 3 years and 6 months
Percentage of Participants with Re-occurrence of CRS for All Grades
기간: Up to approximately 3 years and 6 months
Percentage of participants with re-occurrence of CRS for all Grades will be reported.
Up to approximately 3 years and 6 months
Overall Response Rate (ORR)
기간: Up to approximately 3 years and 6 months
ORR is defined as the percentage of participants who achieve partial response (PR) or better prior to progressive disease (PD) or subsequent antimyeloma therapy, in accordance with the international myeloma working group (IMWG) criteria.
Up to approximately 3 years and 6 months
Complete Response (CR) or Better
기간: Up to approximately 3 years and 6 months
CR or better rate is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to PD or subsequent antimyeloma therapy, in accordance with the IMWG criteria.
Up to approximately 3 years and 6 months
Very Good Partial Response (VGPR) or Better
기간: Up to approximately 3 years and 6 months
VGPR or better rate is defined as the percentage of participants achieving VGPR, CR or sCR prior to PD or subsequent antimyeloma therapy, in accordance with the IMWG criteria.
Up to approximately 3 years and 6 months
Duration of Response (DoR)
기간: Up to approximately 3 years and 6 months
DoR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of PD according to the IMWG response criteria or death due to any cause, whichever occurs first.
Up to approximately 3 years and 6 months
Time to Response (TTR)
기간: Up to approximately 3 years and 6 months
TTR is defined as the time from the date of randomization to the date of first documentation of a confirmed response (PR or better) for participants who have PR or better as their best response.
Up to approximately 3 years and 6 months
Progression-Free Survival (PFS)
기간: Up to approximately 3 years and 6 months
PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria.
Up to approximately 3 years and 6 months
Time To Next Line of Therapy (TTNT)
기간: Up to approximately 3 years and 6 months
TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment. Death due to progressive disease without the start of any subsequent antimyeloma therapy will be considered as an event.
Up to approximately 3 years and 6 months
Time to the First Treatment-emergent Infection with Toxicity Grade >=3
기간: Up to approximately 3 years and 6 months
Time to the first treatment-emergent infection with toxicity grade >=3 will be reported.
Up to approximately 3 years and 6 months
Percentage of Participants with Primary Immunoglobulin Replacement Therapy (IgRT) Prophylaxis Use
기간: Up to approximately 3 years and 6 months
Percentage of participants with primary IgRT prophylaxis use will be reported.
Up to approximately 3 years and 6 months
Percentage of Participants with Secondary IgRT Prophylaxis Use or Without IgRT Prophylaxis Use
기간: Up to approximately 3 years and 6 months
Percentage of participants with secondary IgRT prophylaxis use or without IgRT prophylaxis use will be reported.
Up to approximately 3 years and 6 months
Percentage of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
기간: Up to approximately 3 years and 6 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent antimyeloma therapy, whichever is earlier, or any follow-up AE (linked to an existing TEAE) with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy, or any AE that is considered treatment-related regardless of the start date of the event, is considered to be treatment-emergent. TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0. Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, Grade 5= death related to adverse event.
Up to approximately 3 years and 6 months
Percentage of Participants with Abnormalities in Laboratory Parameters
기간: Up to approximately 3 years and 6 months
Percentage of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.
Up to approximately 3 years and 6 months
Percentage of Participants with Incidence of Adverse Events of Clinical Interests
기간: Up to approximately 3 years and 6 months
Percentage of participants with incidence of adverse events of clinical interests such as cytopenia will be reported.
Up to approximately 3 years and 6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 20일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2030년 11월 8일

연구 등록 날짜

최초 제출

2026년 5월 11일

QC 기준을 충족하는 최초 제출

2026년 5월 11일

처음 게시됨 (실제)

2026년 5월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 11일

마지막으로 확인됨

2026년 5월 1일

추가 정보

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IPD 계획 설명

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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