A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 419
- 试验地点
- 88
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to compare the efficacy of ciltacabtagene autoleucel (cilta-cel) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Measurable disease at screening as defined by any of the following: (a) Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 0.5 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours; or (b) Light chain multiple myeloma without measurable M-protein in the serum or the urine: Serum free light chain >=10 mg/dL and abnormal serum free light chain ratio
- Have received 1 to 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)
- Have documented evidence of PD by International Myeloma Working Group (IMWG) criteria based on investigator's determination on or within 6 months of their last regimen
- Be refractory to lenalidomide per IMWG consensus guidelines (failure to achieve minimal response or progression on or within 60 days of completing lenalidomide therapy). Progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion. For participants with more than 1 prior line of therapy, there is no requirement to be lenalidomide refractory to the most recent line of prior therapy. However, participants must be refractory to lenalidomide in at least one prior line
- Have clinical laboratory values meeting the following criteria during the Screening Phase (re testing is allowed but the below criteria must be met in the latest test prior to randomization):
- Hemoglobin >=8 gram per deciliter (g/dL) (without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted);
- Absolute neutrophil count (ANC) >=1 * 10^9 per liter (L) (without recombinant human granulocyte colony-stimulating factor [G-CSF] within 7 days and without pegylated G-CSF within 14 days of the laboratory test);
- Platelet count >=75 * 10^9/L (without prior platelet transfusion within 7 days before the laboratory test) in participants in whom less than (<) 50 percent (%) of bone marrow nucleated cells are plasma cells; platelet count >=50 * 10^9/L (without prior platelet transfusion within 7 days before the laboratory test) in participants in whom >=50% of bone marrow nucleated cells are plasma cells;
- Lymphocyte count >=0.3 * 10^9/L;
- Aspartate aminotransferase (AST) less than or equal to (<=)3 * upper limit of normal (ULN);
- Alanine aminotransferase (ALT) <=3 * ULN;
- Total bilirubin <=2.0 * ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=1.5 * ULN is required);
- Estimated glomerular filtration rate >=40 milliliter per minute (mL/min) per 1.73 meter square (m^2) (to be calculated using the Modification of Diet in Renal Disease [MDRD] formula)
排除标准
- Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy directed at any target
- Any previous therapy that is targeted to B-cell maturation antigen (BCMA)
- Ongoing toxicity from previous anticancer therapy that has not resolved to baseline levels or to Grade 1 or less; except for alopecia
- Participants with Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy will not be permitted to receive pomalidomide, bortezomib, and dexamethasone (PVd) as standard therapy or bridging therapy; however, participants may receive daratumumab, pomalidomide, and dexamethasone (DPd) as standard therapy or bridging therapy
- Received a cumulative dose of corticosteroids equivalent to >=70 mg of prednisone within the 7 days prior to randomization
- Monoclonal antibody treatment within 21 days
- Cytotoxic therapy within 14 days
- Proteasome inhibitor therapy within 14 days
- Immunomodulatory drug (IMiD) therapy within 7 days
研究组 & 干预措施
Arm A: PVd or DPd (Standard Therapy)
Participants will receive either PVd or DPd as a standard therapy. In PVd treatment, participants will receive oral pomalidomide 4 mg on Days 1 to 14 in each cycle; bortezomib 1.3 mg/meter square (m^2) SC on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each cycle will consist of 21 days. In DPd treatment, participants will receive daratumumab SC 1800 mg weekly on Days 1, 8, 15, and 22 (Cycles 1 and 2), every 2 weeks on Days 1 and 15 (Cycles 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); oral pomalidomide 4 mg on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg oral or IV weekly on Days 1, 8, 15, and 22 (Cycle 1 onwards). Each cycle will consist of 28 days. Participants will continue to receive PVd or DPd until confirmed PD, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs earlier.
干预措施: Pomalidomide (Drug)
Arm A: PVd or DPd (Standard Therapy)
Participants will receive either PVd or DPd as a standard therapy. In PVd treatment, participants will receive oral pomalidomide 4 mg on Days 1 to 14 in each cycle; bortezomib 1.3 mg/meter square (m^2) SC on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each cycle will consist of 21 days. In DPd treatment, participants will receive daratumumab SC 1800 mg weekly on Days 1, 8, 15, and 22 (Cycles 1 and 2), every 2 weeks on Days 1 and 15 (Cycles 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); oral pomalidomide 4 mg on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg oral or IV weekly on Days 1, 8, 15, and 22 (Cycle 1 onwards). Each cycle will consist of 28 days. Participants will continue to receive PVd or DPd until confirmed PD, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs earlier.
干预措施: Bortezomib (Drug)
Arm A: PVd or DPd (Standard Therapy)
Participants will receive either PVd or DPd as a standard therapy. In PVd treatment, participants will receive oral pomalidomide 4 mg on Days 1 to 14 in each cycle; bortezomib 1.3 mg/meter square (m^2) SC on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each cycle will consist of 21 days. In DPd treatment, participants will receive daratumumab SC 1800 mg weekly on Days 1, 8, 15, and 22 (Cycles 1 and 2), every 2 weeks on Days 1 and 15 (Cycles 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); oral pomalidomide 4 mg on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg oral or IV weekly on Days 1, 8, 15, and 22 (Cycle 1 onwards). Each cycle will consist of 28 days. Participants will continue to receive PVd or DPd until confirmed PD, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs earlier.
干预措施: Dexamethasone (Drug)
Arm A: PVd or DPd (Standard Therapy)
Participants will receive either PVd or DPd as a standard therapy. In PVd treatment, participants will receive oral pomalidomide 4 mg on Days 1 to 14 in each cycle; bortezomib 1.3 mg/meter square (m^2) SC on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each cycle will consist of 21 days. In DPd treatment, participants will receive daratumumab SC 1800 mg weekly on Days 1, 8, 15, and 22 (Cycles 1 and 2), every 2 weeks on Days 1 and 15 (Cycles 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); oral pomalidomide 4 mg on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg oral or IV weekly on Days 1, 8, 15, and 22 (Cycle 1 onwards). Each cycle will consist of 28 days. Participants will continue to receive PVd or DPd until confirmed PD, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs earlier.
干预措施: Daratumumab (Drug)
Arm B: (Ciltacabtagene Autoleucel [Cilta-cel])
Participants will receive at least one cycle of bridging therapy (PVd or DPd) and additional cycles of bridging therapy may be considered based on participant's clinical status and timing of availability of cilta-cel along with conditioning regimen (cyclophosphamide 300 milligram [mg]/m^2 intravenous [IV] and fludarabine 30 mg/m^2 IV daily, for 3 days), and cilta-cel infusion 0.75 * 10^6 chimeric antigen receptor (CAR)-positive viable T cells/ kilogram (kg).
干预措施: Cilta-cel (Drug)
方案终点
主要结局
Progression Free Survival (PFS)
时间窗: From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years)
PFS: defined as time from date of randomization to date of first documented progressed disease (PD) as per International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 grams per deciliter \[g/dL\] and \>=200 milligrams \[mg\] per 24 hours, respectively); only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase of \>10 mg/dL); only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell (PC)% (absolute increase of \>=10%), appearance of new lesion; definite development of new bone lesions or definite increase in size of existing bone lesions, \>=50% increase in circulating PCs (minimum of 200 cells per microliter \[uL\]) if this was only measure of disease.
次要结局
- Overall Survival (OS)(From randomization (Day 1) up to 7 years)
- Percentage of Participants Who Achieved Complete Response (CR) or Stringent Complete Response (sCR)(From randomization (Day 1) up to 7 years)
- Percentage of Participants Who Achieved Overall Minimal Residual Disease (MRD) Negative Status (at 10^-5)(From randomization (Day 1) up to 7 years)
- Percentage of Participants Who Were in CR or sCR and Achieved MRD-negative Status at 12 Months +/-3 Months(From randomization (Day 1) up to 12 months +/- 3 months)
- Overall Response Rate (ORR)(From randomization (Day 1) up to 7 years)
- Number of Participants With Treatment-emergent Adverse Events (AEs)(From Cycle 1 Day 1 up to 7 years)
- Change From Baseline in Levels of JNJ-68284528 T Cell Expansion (Proliferation), and Persistence on Participants Who Received Cilta-cel as Study Treatment (Arm B)(From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days))
- Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 Item (EORTC-QLQ-C30) Scale Score(From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days))
- Change From Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire Scale Score(From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days))
- Percentage of Participants Who Achieved Sustained MRD-negative Status(From randomization (Day 1) up to 7 years)
- Change From Baseline in Systemic Cytokine Concentrations on Participants Who Received Cilta-cel as Study Treatment (Arm B)(From baseline (Cycle 1 Day 1) up to 7 years)
- Change From Baseline in Levels of CAR-T Cell Activation Markers on Participants Who Received Cilta-cel as Study Treatment (Arm B)(From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days))
- Number of Participants With Anti-JNJ-68284528 Antibodies on Participants Who Received Cilta-cel as Study Treatment (Arm B)(From Cycle 1 Day 1 up to 7 years)
- Change From Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score(From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days))
- Time to Worsening of Symptoms Using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Total Symptom Score(From randomization (Day 1) up to 7 years)
- Progression Free Survival on Next-line Therapy (PFS2)(From randomization (Day 1) up to 7 years)
- Change From Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Sore(From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days))
- Number of Participants With Treatment-emergent Adverse Events (AEs) by Severity(From Cycle 1 Day 1 up to 7 years)
- Number of Participants in Health-Related Quality of Life as Assessed by The Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item(From randomization (Day 1) up to 7 years)
试验结果
结果已于 2025-05-20 在 ClinicalTrials.gov 公示。 在 ClinicalTrials.gov 查看
受试者流程
入组 419 人 · 完成 0 人
主要终点
Progression Free Survival (PFS)
months · 95% Confidence Interval · 时间窗: From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years)
| Arm A: Standard Therapy: PVd or DPd （n=211） | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) （n=208） |
|---|---|
| 11.79 (9.66–14.00) | NA (34.50–NA) |
The intent-to-treat (ITT) analysis set included all participants who were randomized in the study.
Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]): NA refers to data not estimable for median and upper limit of 95% confidence interval due to insufficient number of participants with events.
安全性
| 组别 | 严重不良事件 | 死亡 |
|---|---|---|
| Arm A: Standard Therapy: PVd or DPd | 98 / 208 | 83 / 211 |
| Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | 98 / 208 | 50 / 208 |
最常见的严重不良事件（人数）
| 事件 | Arm A: Standard Therapy: PVd or DPd | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) |
|---|---|---|
| Pneumonia | 14 / 208 | 8 / 208 |
| Covid-19 Pneumonia | 12 / 208 | 12 / 208 |
| Facial Paralysis | 1 / 208 | 9 / 208 |
| Cytokine Release Syndrome | 1 / 208 | 7 / 208 |
| Covid-19 | 7 / 208 | 6 / 208 |
| Febrile Neutropenia | 6 / 208 | 5 / 208 |
| Diarrhoea | 0 / 208 | 5 / 208 |
| Pyrexia | 5 / 208 | 4 / 208 |
| Pneumocystis Jirovecii Pneumonia | 5 / 208 | 1 / 208 |
| Upper Respiratory Tract Infection | 5 / 208 | 4 / 208 |
数值为申办方在 ClinicalTrials.gov 公示的原始数据，未经重新计算；括号内为公示的离散度（如 95% 置信区间）。
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研究者
研究点 (88)
标识符
- NCT 编号
- NCT04181827
- 其他研究编号
- CR108695, 68284528MMY3002, 2019-001413-16, 2023-506588-32-00, 2023, 2019
日期
- 首次提交
- (6年前)
- 首次发布
- (6年前)
- 主要完成日期
- (2年前)
- 研究完成日期
- (6个月后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 是
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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