다발성 골수종 환자를 대상으로 한 다른 항암 요법과 Talquetamab의 연구 (MonumenTAL-2)
다발성 골수종 환자를 대상으로 다른 항암 요법과 Talquetamab을 병용하는 다군 임상 1b상 연구
The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Groningen, 네덜란드, 9713 GZ
- UMCG
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Maastricht, 네덜란드, 6229 HX
- Maastricht University Medical Centre
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Utrecht, 네덜란드, 3584 CX
- UMCU
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama Birmingham
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California
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San Francisco, California, 미국, 94143
- University of California San Francisco
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Colorado
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Denver, Colorado, 미국, 80218
- Colorado Blood Cancer Institute
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana University
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- Hackensack University Medical Center
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New York
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New York, New York, 미국, 10065
- Weill Cornell Medical College
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New York, New York, 미국, 10029
- Mt. Sinai School of Medicine
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North Carolina
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Charlotte, North Carolina, 미국, 28204
- Levine Cancer Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15232
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, 미국, 37203
- Tennessee Oncology
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Medical College Of Wisconsin
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Brussels, 벨기에, 1200
- Cliniques Universitaires St-Luc
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Edegem, 벨기에, 2650
- UZA
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Ghent, 벨기에, 9000
- UZ Gent
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Leuven, 벨기에, 3000
- UZ Leuven
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London, 영국, W1T 7HA
- University College Hospital London
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Manchester, 영국, M20 4BX
- The Christie Nhs Foundation Trust
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Oxford, 영국, OX3 7LE
- Churchill Hospital
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Surrey, 영국, SM2 5PT
- The Royal Marsden NHS Trust Sutton
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Nantes, 프랑스, 44093
- CHU Nantes
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Pessac, 프랑스, 33604
- CHU de Bordeaux - Hospital Haut-Leveque
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Rennes, 프랑스, 35000
- Chu Rennes Hopital Pontchaillou
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Toulouse, 프랑스, 31059
- Institut Universitaire du cancer de Toulouse-Oncopole
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Fitzroy, 호주, 3065
- St Vincents Hospital Melbourne
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Melbourne, 호주, 3004
- Alfred Health
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Southport, 호주, 4215
- Gold Coast University Hospital
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Wollongong, 호주, 2500
- Wollongong Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (>=) 1.0 gram 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
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration
- A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration
- Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program
Exclusion Criteria:
- Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the start of study treatment administration
- Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Known to be seropositive for human immunodeficiency virus
- History of stroke or seizure within 6 months prior to the first dose of study treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Treatment Regimen A: Talquetamab + Carfilzomib
Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion. |
Talquetamab will be administered subcutaneously.
다른 이름들:
Carfilzomib will be administered as an IV infusion. |
|
실험적: Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib
Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion. |
Talquetamab will be administered subcutaneously.
다른 이름들:
Carfilzomib will be administered as an IV infusion. Daratumumab will be administered subcutaneously. |
|
실험적: Treatment Regimen C: Talquetamab + Lenalidomide
Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally. |
Talquetamab will be administered subcutaneously.
다른 이름들:
Lenalidomide will be self-administered orally. |
|
실험적: Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide
Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally. |
Talquetamab will be administered subcutaneously.
다른 이름들:
Daratumumab will be administered subcutaneously. Lenalidomide will be self-administered orally. |
|
실험적: Treatment Regimen E: Talquetamab + Pomalidomide
Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally. |
Talquetamab will be administered subcutaneously.
다른 이름들:
Pomalidomide will be self-administered orally. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
기간: Up to 1 year and 10 months
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
Up to 1 year and 10 months
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Number of Participants with AEs by Severity
기간: Up to 1 year and 10 months
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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 AE. |
Up to 1 year and 10 months
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Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
기간: Up to 1 year and 6 months
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Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported. |
Up to 1 year and 6 months
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Number of Participants with Dose Limiting Toxicity (DLT)
기간: Up to 49 days
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Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity of grade 3 or higher, clinical laboratory abnormalities, or hematologic toxicity. |
Up to 49 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall Response Rate (ORR)
기간: Up to 1 year and 10 months
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ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria. Response to treatment will be evaluated by the investigator based on IMWG criteria. |
Up to 1 year and 10 months
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Very Good Partial Response (VGPR) or Better Response Rate
기간: Up to 1 year and 10 months
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VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response [sCR] + complete response [CR] +VGPR) according to the IMWG 2016 criteria. |
Up to 1 year and 10 months
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Complete Response (CR) or Better Response Rate
기간: Up to 1 year and 10 months
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CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria. |
Up to 1 year and 10 months
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Stringent Complete Response (sCR)
기간: Up to 1 year and 10 months
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sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria. |
Up to 1 year and 10 months
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Duration of Response
기간: Up to 1 year and 10 months
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Duration of response is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG 2016 criteria, or death due to disease progression, whichever occurs first. |
Up to 1 year and 10 months
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Time to Response
기간: Up to 1 year and 10 months
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Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better. |
Up to 1 year and 10 months
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Serum Concentration of Talquetamab
기간: Up to 1 year and 10 months
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Serum samples will be analyzed to determine concentrations of talquetamab. |
Up to 1 year and 10 months
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Serum Concentration of Daratumumab
기간: Up to 1 year and 10 months
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Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D. |
Up to 1 year and 10 months
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Number of Participants with Anti-Drug Antibodies to Talquetamab
기간: Up to 1 year and 10 months
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Number of participants with anti-drug antibodies to talquetamab will be reported. |
Up to 1 year and 10 months
|
|
Number of Participants with Anti-Drug Antibodies to Daratumumab
기간: Up to 1 year and 10 months
|
Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D. |
Up to 1 year and 10 months
|
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Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
기간: Up to 1 year and 10 months
|
Number of participants with anti-drug antibodies to rHuPH20 will be reported. |
Up to 1 year and 10 months
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CR108946
- 2020-004502-55 (EudraCT 번호)
- 64407564MMY1004 (기타 식별자: Janssen Research & Development, LLC)
- 2023-503620-60-00 (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 and 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
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