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Belantamamafodotin Plus Standard of Care (SoC) 在新诊断多发性骨髓瘤中的研究 (DREAMM 9)

2026年11月6日更新者：GlaxoSmithKline

一项旨在调查 Belantamab Mafodotin 联合护理标准在新诊断多发性骨髓瘤参与者中的安全性、药代动力学、药效学和临床活性的随机、剂量和时间表评估研究

This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. Belantamab mafodotin will be administered in combination with VRd every 3 weeks (Q3W), every 6 weeks (Q6W), or every 9 weeks (Q9W) to Cycle 8, and then in combination with Rd every 4 weeks (Q4W), every 8 weeks (Q8W), or every 12 weeks (Q12W) thereafter. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.

研究概览

地位

主动，不招人

条件

多发性骨髓瘤

干预/治疗

研究类型

介入性

注册 (实际的)

118

阶段

阶段1

扩展访问

得到正式认可的出售给公众。查看扩展访问记录。

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

加拿大
- Alberta
  - Edmonton、Alberta、加拿大、T6G 1Z2
    - GSK Investigational Site
- Ontario
  - London、Ontario、加拿大、N6A 5W9
    - GSK Investigational Site
德国
- - Dresden、德国、01307
    - GSK Investigational Site
  - Hamburg、德国、20246
    - GSK Investigational Site
  - Schwerin、德国、19049
    - GSK Investigational Site
  - Tübingen、德国、72076
    - GSK Investigational Site
意大利
- - Bologna、意大利、40138
    - GSK Investigational Site
  - Meldola FC、意大利、47014
    - GSK Investigational Site
法国
- - Poitiers、法国、86021
    - GSK Investigational Site
波兰
- - Lublin、波兰、20-081
    - GSK Investigational Site
  - Poznan、波兰、61-848
    - GSK Investigational Site
澳大利亚
- New South Wales
  - Newcastle、New South Wales、澳大利亚、2298
    - GSK Investigational Site
- Victoria
  - Clayton、Victoria、澳大利亚、3168
    - GSK Investigational Site
  - Fitzroy、Victoria、澳大利亚、3065
    - GSK Investigational Site
美国
- Kansas
  - Westwood、Kansas、美国、66205
    - GSK Investigational Site
- North Carolina
  - Charlotte、North Carolina、美国、28204
    - GSK Investigational Site
- Wisconsin
  - Madison、Wisconsin、美国、53792-0001
    - GSK Investigational Site
英国
- - Leicester、英国、LE1 5WW
    - GSK Investigational Site
  - Oxford、英国、OX3 7LE
    - GSK Investigational Site
- Hampshire
  - Southampton、Hampshire、英国、SO16 6YD
    - GSK Investigational Site
西班牙
- - Barcelona、西班牙、08036
    - GSK Investigational Site
  - Madrid、西班牙、28027
    - GSK Investigational Site
  - Málaga、西班牙、29010
    - GSK Investigational Site
  - PamplonaNavarra、西班牙、31008
    - GSK Investigational Site
  - Pozuelo de AlarcOn Madr、西班牙、28223
    - GSK Investigational Site
  - Santander、西班牙、39008
    - GSK Investigational Site
- Barcelona
  - Badalona、Barcelona、西班牙、08916
    - GSK Investigational Site
韩国
- - Seoul、韩国、03080
    - GSK Investigational Site
  - Seoul、韩国、03722
    - GSK Investigational Site
  - Seoul、韩国、137-701
    - GSK Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Participant must be over 18 years of age inclusive, at the time of signing the informed consent.
Diagnosis of multiple myeloma with a requirement for treatment as documented per international myeloma working group (IMWG) criteria.
Must have at least one aspect of measurable disease, defined as one of the following:
Urine M-protein excretion >=200 mg/24 hours (>=0.2 gram [g]/24 hours), or
Serum M-protein concentration >=0.5 grams per deciliter (g/dL) (>=5.0 gram per liter [g/L]), or
Serum free light chain (FLC) assay: involved FLC level >=10 milligrams per deciliter (mg/dL) (>=100 milligram per liter [mg/L]) and an abnormal serum free light chain ratio (<0.26 or >1.65).
Not a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to presence of significant comorbid condition(s), such as cardiac, pulmonary or other major organ dysfunction that are likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation, as judged by the investigator.
Eastern cooperative oncology group (ECOG) status of 0-2
Adequate organ system functions as defined by the laboratory assessments listed as following: Absolute neutrophil count (ANC) >=1.5 x 10^9/L; Hemoglobin >=8.0 g/dL; Platelets >=75 x 10^9/L; Total bilirubin <=1.5 x upper limit of normal (ULN); (Isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%); Alanine aminotransferase (ALT) <=2.5 x ULN; eGFR >=30 mL/minute/1.73 meter^2; Urine Dipstick for protein OR Albumin/creatinine ratio (from spot urine)- Negative/trace (if >=1 plus only eligible if confirmed <=500 mg/gram (56 mg/millimoles [mmol]) by albumin/creatinine ratio (spot urine from first void); Left Ventricular Ejection Fraction (LVEF) by echocardiogram (ECHO) of >=35% participants with low LVEF (per institutional standards), consider referring to cardiology per local standards of care.
Sex and Contraception/Barrier Requirements (Female):
Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
Is NOT a woman of childbearing potential (WOCBP) or Due to lenalidomide being a thalidomide analogue with risk for embryofetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, and bortezomib having the potential to cause fetal harm, WOCBP participants will be eligible if they commit to either: abstain continuously from heterosexual sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR to use birth control as follows: Two methods of reliable birth control (one method that is highly effective and one additional effective (barrier) method), beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide treatment. Thereafter, WOCBP participants must use one method of reliable birth control that is highly effective for a further 3 months following discontinuation of belantamab mafodotin, or a further 6 months following discontinuation of bortezomib, whichever is longer. WOCBP must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during treatment, during dose interruptions and for 28-days following the last dose of lenalidomide, 4 months following discontinuation of belantamab mafodotin treatment or 7-months following the last dose of bortezomib, whichever is longer. Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing the start of lenalidomide therapy.

The participant should not receive lenalidomide until the investigator has verified that the results of these pregnancy tests are negative. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

Sex and Contraception/Barrier Requirements (Male):
Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Male participants are eligible to participate if they agree to the following from the time of first dose of study treatment until 28-days after the last dose of lenalidomide, 4-months after the last dose of bortezomib, or 6 months after the last dose of belantamab mafodotin, whichever is longer, to allow for clearance of any altered sperm: Refrain from donating sperm - Plus either: - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below: Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a WOCBP. Male participants should also use a condom when having sexual intercourse with pregnant females.
Capable of giving signed informed consent.

Exclusion Criteria:

Smoldering multiple myeloma (SMM).
Prior systemic therapy for multiple myeloma, or SMM. NOTE: An emergency course of steroids (defined as no greater than 40 mg of dexamethasone, or equivalent per day for a maximum of 4 days (that is, a total of 160 mg) is permitted. NOTE: Focal palliative radiation is permitted prior to enrollment, provided that it occurred at least 2 weeks prior to the first dose of study drug, that the participant has recovered from radiation-related toxicities, and that the participant did not require corticosteroids for radiation-induced adverse events.
Participant is eligible for high dose chemotherapy with ASCT, as determined by a frailty score of 0 as assessed by the IMWG frailty index.
Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the national cancer institute (NCI)-common terminology criteria for adverse events (CTCAE) Version 5.
Major surgery within 4 weeks prior to the first dose of study drug.
Presence of active renal condition (infection, requirement for dialysis or any other significant condition that could affect participant's safety). Participants with isolated proteinuria resulting from multiple myeloma (MM) are eligible, provided they fulfil criteria.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
Evidence of active mucosal or internal bleeding uncontrolled by local therapy and not explained by reversible coagulopathy.
Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease as per the Investigator's assessment).
Participants with previous or concurrent malignancies other than multiple myeloma are excluded. Exceptions are surgically treated cervical carcinoma in situ, or any other malignancy that has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. Note: Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction.
Evidence of cardiovascular risk including any of following: Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities including second degree (Mobitz Type II) or third degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening.; Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; Uncontrolled hypertension.
Active infection requiring treatment.
Known human immunodeficiency virus (HIV) infection.
Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb), at Screening or within 3 months prior to first dose of study treatment.
Positive hepatitis C antibody test result.
Current corneal epithelial disease except for mild punctate keratopathy. Note: Participants with mild punctate keratopathy are allowed.
Intolerance or contraindications to anti-viral prophylaxis.
Unable to tolerate antithrombotic prophylaxis.
AL amyloidosis (light chain amyloidosis), active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes (POEMS) syndrome or active plasma cell leukemia at the time of screening.
Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma.
Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.
Plasmapheresis within 7 days prior to the first dose of study drug.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：顺序分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Cohort 1: belantamab mafodotin 1.9 mg/kg Q3/4W + VRd/Rd Participants will receive 1.9 milligram /kilogram (mg/kg) Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.	药品：Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. 药品：Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. 药品：Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. 药品：Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
实验性的：Cohort 2: belantamab mafodotin 1.4 mg/kg Q6/8W + VRd/Rd Participants will receive 1.4 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.	药品：Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. 药品：Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. 药品：Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. 药品：Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
实验性的：Cohort 3: belantamab mafodotin 1.9 mg/kg Q6/8W + VRd/Rd Participants will receive 1.9 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.	药品：Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. 药品：Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. 药品：Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. 药品：Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
实验性的：Cohort 4: belantamab mafodotin 1.0 mg/kg Q3/4W + VRd/Rd Participants will receive 1.0 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.	药品：Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. 药品：Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. 药品：Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. 药品：Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
实验性的：Cohort 5: belantamab mafodotin 1.4 mg/kg Q3/4W + VRd/Rd Participants will receive 1.4 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.	药品：Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. 药品：Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. 药品：Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. 药品：Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
实验性的：Cohort 6: belantamab mafodotin 1.4mg/kg cycle 1, 1.0 mg/kg Q9/12W Cycle 4+VRd/Rd Based on emerging data from Cohort 2-5, participants will receive 1.4 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1, followed by 1.0 mg/kg dose on Day 1 of every third cycle from cycle 4 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	药品：Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. 药品：Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. 药品：Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. 药品：Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
实验性的：Cohort 7: belantamab mafodotin 1.9 mg/kg Cycle 1, 1.4 mg/kg Q9/12W Cycle 4+VRd/Rd Based on emerging data from Cohort 2-5, participants will receive 1.9 mg/kg dose of belantamab mafodotin of cycle 1, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 4 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	药品：Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. 药品：Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. 药品：Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. 药品：Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
实验性的：Cohort 8a : belantamab mafodotin 1.9 mg/kg Cycle 1,4; 1.4 mg/kg Q9/12W from Cycle 7 +VRd/Rd Based on emerging data from Cohort 6-7, participants will receive 1.9 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 4, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 7 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	药品：Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. 药品：Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. 药品：Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. 药品：Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
实验性的：Cohort 8b: belantamab mafodotin 1.4 mg/kg Cycle 1,3; 1.0 mg/kg Q9/12W from Cycle 6 +VRd/Rd Based on emerging data from Cohort 6-7, participants will receive 1.4 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 3, then 1.0 mg/kg on Day 1 of every third cycle from cycle 6 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	药品：Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. 药品：Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. 药品：Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. 药品：Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
实验性的：Cohort 8c: belantamab mafodotin 1.0 mg/kg Cycle 1,5;1.0 mg/kg Q9/12W from Cycle 9 +VRd/Rd Based on emerging data from Cohort 6-7, participants will receive 1.0 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 5, then 1.0 mg/kg on day 1 of every third cycle from cycle 9 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	药品：Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. 药品：Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. 药品：Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. 药品：Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Number of Participants With Dose-limiting Toxicities (DLTs) of Belantamab Mafodotin 大体时间：Up to 63 days	Criteria for DLT included hematologic indicators including Grade(G) 3-5 febrile neutropenia, G4 neutropenia >7 days, G3 or greater thrombocytopenia accompanied by clinically significant bleeding; non-hematologic criteria, including Any G3/4 non-hematologic toxicity, G5 non hematologic toxicity, G3 or greater corneal toxicity; Liver toxicity meeting prespecified GSK liver stopping criteria. Severity was graded using National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.	Up to 63 days
Number of Participants With Adverse Events (AEs) 大体时间：Up to approximately 284 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.	Up to approximately 284 weeks

次要结果测量

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

GlaxoSmithKline

调查人员

研究主任：GSK Clinical Trials、GlaxoSmithKline

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年12月18日

初级完成 (实际的)

2025年6月2日

研究完成 (估计的)

2028年3月10日

研究注册日期

首次提交

2019年9月13日

首先提交符合 QC 标准的

2019年9月13日

首次发布 (实际的)

2019年9月16日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月6日

最后验证

2026年11月1日

结果测量	措施说明	大体时间
Lenalidomide Relative Dose Intensity (RDI) After Treatment With Belantamab Mafodotin in Combination With VRd 大体时间：Up to 168 days	Relative Dose Intensity (RDI) is defined as the percentage of the amount of a drug actually delivered (actual dose intensity [DI]) relative to the amount planned (planned DI).	Up to 168 days
Bortezomib RDI After Treatment With Belantamab Mafodotin in Combination With VRd 大体时间：Up to 168 days	Relative Dose Intensity (RDI) is defined as the percentage of the amount of a drug actually delivered (actual dose intensity [DI]) relative to the amount planned (planned DI).	Up to 168 days
Cumulative Administered Dose of Belantamab Mafodotin After Treatment in Combination With VRd 大体时间：Up to 84 days	Cumulative Dose is sum of the actual dose administered during each infusion for a participant.	Up to 84 days
Area Under the Concentration Time Curve From 0 to 504 Hours [AUC (0 - 504 Hours)] of Belantamab Mafodotin 大体时间：Day 1 Cycle 1 Pre-Dose, End of Infusion (EOI); Anytime between Day 8 and Day 15 after Start of Infusion (SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. The last PK assessment used to derive AUC0-504h was intended to be collected approximately 504 hours (21 days) after the start of the first infusion. Depending on the dosing schedule, this assessment occurred either at the Day 22 visit (±3 days) for participants in the Q6/8W and Q9/12W cohorts or at the Cycle 2 Day 1 pre-dose visit for participants in the Q3W cohorts. Therefore, samples collected at Day 22 or Cycle 2 Day 1 predose represent the protocol-defined PK assessment performed at approximately 504 hours after Dose 1.	Day 1 Cycle 1 Pre-Dose, End of Infusion (EOI); Anytime between Day 8 and Day 15 after Start of Infusion (SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period)
Maximum Plasma Concentration (Cmax) of Belantamab Mafodotin 大体时间：Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)
Time to Reach Cmax (Tmax) of Belantamab Mafodotin 大体时间：Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) of Belantamab Mafodotin 大体时间：Pre-dose at Day 1 of Cycle 1, 2, 3, 4, 5, 7, 10, 13, 14, 15, 16, 17, 23, 24, 27, 28, 29, 30, 31, 34, 36, 37, 41, 43, 49	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. C-trough were measured prior to the next dose for each cycle.	Pre-dose at Day 1 of Cycle 1, 2, 3, 4, 5, 7, 10, 13, 14, 15, 16, 17, 23, 24, 27, 28, 29, 30, 31, 34, 36, 37, 41, 43, 49
Observed Plasma Concentration at the End of Infusion (C-EOI) of Belantamab Mafodotin 大体时间：End of infusion at Day 1 on C1, C2, C3, C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19, C20, C21, C22, C24, C25, C26, C27 (up to approximately 81 weeks)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin.	End of infusion at Day 1 on C1, C2, C3, C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19, C20, C21, C22, C24, C25, C26, C27 (up to approximately 81 weeks)
Time of Last Observed Quantifiable Concentration (Tlast) of Belantamab Mafodotin 大体时间：Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. The last PK assessment used to derive Tlast was intended to be collected approximately 504 hours (21 days) after the start of the first infusion. Depending on the dosing schedule, this assessment occurred either at the Day 22 visit (±3 days) for participants in the Q6/8W and Q9/12W cohorts or at the Cycle 2 Day 1 pre-dose visit for participants in the Q3W cohorts. Therefore, samples collected at Day 22 or Cycle 2 Day 1 predose represent the protocol-defined PK assessment performed at approximately 504 hours after Dose 1.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period)
Clearance of Belantamab Mafodotin 大体时间：Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)
Volume of Distribution at Steady State (Vss) of Belantamab Mafodotin 大体时间：Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)
Apparent Terminal Half Life (t1/2) of Belantamab Mafodotin 大体时间：Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)
AUC (0 - 504 Hour) of Cys-mcMMAF 大体时间：Day 1 Cycle 1 Pre-Dose, End of Infusion (EOI); Anytime between Day 8 and Day 15 after Start of Infusion (SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period)	Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF. The last PK assessment used to derive AUC0-504h was intended to be collected approximately 504 hours (21 days) after the start of the first infusion. Depending on the dosing schedule, this assessment occurred either at the Day 22 visit (±3 days) for participants in the Q6/8W and Q9/12W cohorts or at the Cycle 2 Day 1 pre-dose visit for participants in the Q3W cohorts. Therefore, samples collected at Day 22 or Cycle 2 Day 1 predose represent the protocol-defined PK assessment performed at approximately 504 hours after Dose 1.	Day 1 Cycle 1 Pre-Dose, End of Infusion (EOI); Anytime between Day 8 and Day 15 after Start of Infusion (SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period)
Cmax of Cys-mcMMAF 大体时间：D1 C1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72h; D8-15 post Start of Infusion(SOI); 22d post-SOI; PD & EOI at D1 of C2-7,10,14-17,19,22,26; PD at D1 of C13,18,21,23,24,27-31,34,36,37,39,41,43,46,49; End of Treatment(EOT) (~C52, up to ~234weeks)	Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF.	D1 C1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72h; D8-15 post Start of Infusion(SOI); 22d post-SOI; PD & EOI at D1 of C2-7,10,14-17,19,22,26; PD at D1 of C13,18,21,23,24,27-31,34,36,37,39,41,43,46,49; End of Treatment(EOT) (~C52, up to ~234weeks)
Time to Reach Cmax (Tmax) of Cys-mcMMAF 大体时间：Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)	Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)
Observed Plasma C-EOI of Cys-mcMMAF 大体时间：End of infusion at Day 1 on C1, C2, C3, C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19, C20, C21, C22, C24, C25, C26, C27 (up to approximately 81 weeks)	Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF.	End of infusion at Day 1 on C1, C2, C3, C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19, C20, C21, C22, C24, C25, C26, C27 (up to approximately 81 weeks)
Tlast of Cys-mcMMAF 大体时间：Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI)	Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI)
Number of Participants With Positive Post-baseline Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin 大体时间：Up to approximately 234 weeks	Serum samples were collected for the analysis of ADAs of anti-belantamab mafodotin.	Up to approximately 234 weeks
Titers of ADAs Against Belantamab Mafodotin 大体时间：Up to approximately 234 weeks	Serum Samples were collected for the analysis of ADAs of anti-belantamab mafodotin.	Up to approximately 234 weeks
Overall Response Rate (ORR) 大体时间：Up to approximately 284 weeks	ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR: negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR: CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hour (h); PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg/24 h.	Up to approximately 284 weeks
Complete Response Rate (CRR) 大体时间：Up to approximately 284 weeks	CRR is defined as the percentage of participants with a confirmed complete response (CR) or better (i.e. CR and stringent complete response [sCR]), according to the IMWG Response Criteria. CR: negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR: CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.	Up to approximately 284 weeks
Percentage of Participants With Confirmed VGPR or Better 大体时间：Up to approximately 284 weeks	VGPR or better (i.e. VGPR, CR, sCR) is defined as - VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h , CR: negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR: CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.	Up to approximately 284 weeks

Belantamamafodotin Plus Standard of Care (SoC) 在新诊断多发性骨髓瘤中的研究 (DREAMM 9)

一项旨在调查 Belantamab Mafodotin 联合护理标准在新诊断多发性骨髓瘤参与者中的安全性、药代动力学、药效学和临床活性的随机、剂量和时间表评估研究

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

扩展访问

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (实际的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

IPD 共享时间框架

IPD 共享访问标准

IPD 共享支持信息类型

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品