2026-526654-14-01招募中3 期
A Phase 3 Randomized Study Comparing Ramantamig Plus Daratumumab Versus Investigator’s Choice of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 423
- 试验地点
- 88
- 主要终点
- PFS as assessed by a validated computerized algorithm: time from randomization to confirmed progressive disease (per IMWG response criteria) or death, whichever occurs first.
研究概览
简要总结
The primary objective is to evaluate whether ramantamig plus daratumumab (ramantamig D) will result in prolongation of PFS and improved 12 month MRD-negative CR rate, compared with investigator choice (IC) of DVRd or DRd, in patients with NDMM who are ineligible for ASCT as initial therapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •At the time of informed consent, be ≥18 years of age or at least the legal age of majority in the jurisdiction in which the trial is taking place
- •Documented diagnosis of MM according to IMWG diagnostic criteria (Section 12.6)
- •Measurable disease at screening as assessed by central laboratory, defined by any of the following: i. Serum M-protein level ≥1.0 g/dL; or ii. Serum immunoglobulin FLC ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio; or iii. Urine M-protein level ≥200 mg/24 hours (if sFLC assay results are not available)
- •Criterion modified per Amendment
- •4.1 Not considered for high-dose chemotherapy with ASCT due to: i. Ineligible due to advanced age; or ii. Ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT
- •Have an ECOG performance status of 0 to 2 (Oken 1982)
- •Have an eGFR, calculated with the CKD-epi formula using adjusted BSA (Section 12.11), of ≥30 mL/min/1.73m2 during the screening period and within 1 day prior to first administration of trial intervention
- •Have the following laboratory values during the screening period and within 1 day prior to first administration of trial intervention: AST and ALT<2.5xULN; Total bilirubin<1.5xULN, except in participants with congenital nonhemolytic indirect hyperbilirubinemias, such as Gilbert’s syndrome (in which case conjugated [direct] bilirubin ≤1.5×ULN is required)
- •Have the following laboratory values during the screening period and within 1 day prior to first administration of trial intervention: Hemoglobin: ≥7.5 g/dL (≥4.65 mmol/L) (without RBC transfusion within 7 days of the laboratory test; recombinant human erythropoietin use is permitted); Platelets: ≥75×10⁹/L in participants in whom <50% of bone marrow nucleated cells are plasma cells and ≥50×10⁹/L in participants in whom ≥50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test); ANC: ≥1.0×10⁹//L
排除标准
- •Myeloma Frailty Score of ≥2 with the exception of participants who have a score of 2 based on age alone (Section 12.13).
- •Active hepatitis of infectious origin.
- •Received any prior therapy(ies) for treatment of MM or smoldering myeloma, with the exception of emergency use of a short course of corticosteroids. Participants are allowed corticosteroids not exceeding >160 mg of dexamethasone (or equivalent).
- •Received any radiotherapy on measurable STP(s), even in the setting of palliation for symptomatic management. However, if the radiation is given for palliative purposes and the radiation portal covered ≤5% of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy (see Section 12.8).
- •Underwent plasmapheresis within 28 days before randomization
- •History of uncontrolled illness, including but not limited to: a. Acute diffuse infiltrative pulmonary disease b. Has COPD with an FEV1 <50% of predicted normal c. Has moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification. d. Evidence of active systemic viral, fungal or bacterial infection requiring systemic antiviral, antifungal, or antimicrobial therapy. e. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of trial intervention. f. Disabling psychiatric conditions (eg, alcohol or drug abuse), severe dementia, or altered mental status. g. Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization.
- •Suspected or known allergies, hypersensitivity, intolerance or other contraindications to any trial intervention or its excipients.
- •Had major surgery (eg, requiring general anesthesia) or had significant traumatic injury within 2 weeks prior to 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 trial.
- •Any of the following within 6 months prior to first dose of trial intervention: severe or unstable angina, myocardial infarction, major thromboembolic events, clinically significant ventricular arrhythmias or heart failure Class III to IV .
- •Presence of any of the following prior/ current malignancies: 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 (ie, progressing or requiring treatment change in the last 24 months) other than MM except for certain malignancies that are considered cured with minimal risk of recurrence.
- •Plasma cell leukemia at the time of screening, Waldenstrom’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or systemic amyloid light chain amyloidosis.
- •Known active or prior CNS involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain MRI and lumbar cytology are required.
- •Poorly controlled HIV infection.
研究组 & 干预措施
DARZALEX 1800 mg solution for injection
Test
干预措施: DARZALEX 1800 mg solution for injection (Drug)
JNJ-79635322, JNJ-79635322
Test
干预措施: JNJ-79635322 (Drug)
VELCADE 3.5 mg powder for solution for injection, Bortezomib injection, powder, lyophilized, for solution, Bortezomib injection, powder, lyophilized, for solution
Comparator
干预措施: VELCADE 3.5 mg powder for solution for injection (Drug)
VELCADE 3.5 mg powder for solution for injection, Bortezomib injection, powder, lyophilized, for solution, Bortezomib injection, powder, lyophilized, for solution
Comparator
干预措施: Bortezomib injection, powder, lyophilized, for solution (Drug)
Lenalidomide Mylan 20 mg hard capsules, Lenalidomide Mylan 25 mg hard capsules, Lenalidomide Accord 10 mg hard capsules, Lenalidomide Accord 20 mg hard capsules, Lenalidomide Mylan 10 mg hard capsules, Lenalidomide Accord 25 mg hard capsules, Lenalidomide Accord 5 mg hard capsules, Lenalidomide Accord 15 mg hard capsules, Lenalidomide Mylan 15 mg hard capsules, Lenalidomide Mylan 5 mg hard capsules
Comparator
干预措施: Lenalidomide Mylan 20 mg hard capsules (Drug)
Lenalidomide Mylan 20 mg hard capsules, Lenalidomide Mylan 25 mg hard capsules, Lenalidomide Accord 10 mg hard capsules, Lenalidomide Accord 20 mg hard capsules, Lenalidomide Mylan 10 mg hard capsules, Lenalidomide Accord 25 mg hard capsules, Lenalidomide Accord 5 mg hard capsules, Lenalidomide Accord 15 mg hard capsules, Lenalidomide Mylan 15 mg hard capsules, Lenalidomide Mylan 5 mg hard capsules
Comparator
干预措施: Lenalidomide Mylan 25 mg hard capsules (Drug)
Lenalidomide Mylan 20 mg hard capsules, Lenalidomide Mylan 25 mg hard capsules, Lenalidomide Accord 10 mg hard capsules, Lenalidomide Accord 20 mg hard capsules, Lenalidomide Mylan 10 mg hard capsules, Lenalidomide Accord 25 mg hard capsules, Lenalidomide Accord 5 mg hard capsules, Lenalidomide Accord 15 mg hard capsules, Lenalidomide Mylan 15 mg hard capsules, Lenalidomide Mylan 5 mg hard capsules
Comparator
干预措施: Lenalidomide Accord 10 mg hard capsules (Drug)
Lenalidomide Mylan 20 mg hard capsules, Lenalidomide Mylan 25 mg hard capsules, Lenalidomide Accord 10 mg hard capsules, Lenalidomide Accord 20 mg hard capsules, Lenalidomide Mylan 10 mg hard capsules, Lenalidomide Accord 25 mg hard capsules, Lenalidomide Accord 5 mg hard capsules, Lenalidomide Accord 15 mg hard capsules, Lenalidomide Mylan 15 mg hard capsules, Lenalidomide Mylan 5 mg hard capsules
Comparator
干预措施: Lenalidomide Accord 20 mg hard capsules (Drug)
Lenalidomide Mylan 20 mg hard capsules, Lenalidomide Mylan 25 mg hard capsules, Lenalidomide Accord 10 mg hard capsules, Lenalidomide Accord 20 mg hard capsules, Lenalidomide Mylan 10 mg hard capsules, Lenalidomide Accord 25 mg hard capsules, Lenalidomide Accord 5 mg hard capsules, Lenalidomide Accord 15 mg hard capsules, Lenalidomide Mylan 15 mg hard capsules, Lenalidomide Mylan 5 mg hard capsules
Comparator
干预措施: Lenalidomide Mylan 10 mg hard capsules (Drug)
Lenalidomide Mylan 20 mg hard capsules, Lenalidomide Mylan 25 mg hard capsules, Lenalidomide Accord 10 mg hard capsules, Lenalidomide Accord 20 mg hard capsules, Lenalidomide Mylan 10 mg hard capsules, Lenalidomide Accord 25 mg hard capsules, Lenalidomide Accord 5 mg hard capsules, Lenalidomide Accord 15 mg hard capsules, Lenalidomide Mylan 15 mg hard capsules, Lenalidomide Mylan 5 mg hard capsules
Comparator
干预措施: Lenalidomide Accord 25 mg hard capsules (Drug)
Lenalidomide Mylan 20 mg hard capsules, Lenalidomide Mylan 25 mg hard capsules, Lenalidomide Accord 10 mg hard capsules, Lenalidomide Accord 20 mg hard capsules, Lenalidomide Mylan 10 mg hard capsules, Lenalidomide Accord 25 mg hard capsules, Lenalidomide Accord 5 mg hard capsules, Lenalidomide Accord 15 mg hard capsules, Lenalidomide Mylan 15 mg hard capsules, Lenalidomide Mylan 5 mg hard capsules
Comparator
干预措施: Lenalidomide Accord 5 mg hard capsules (Drug)
Lenalidomide Mylan 20 mg hard capsules, Lenalidomide Mylan 25 mg hard capsules, Lenalidomide Accord 10 mg hard capsules, Lenalidomide Accord 20 mg hard capsules, Lenalidomide Mylan 10 mg hard capsules, Lenalidomide Accord 25 mg hard capsules, Lenalidomide Accord 5 mg hard capsules, Lenalidomide Accord 15 mg hard capsules, Lenalidomide Mylan 15 mg hard capsules, Lenalidomide Mylan 5 mg hard capsules
Comparator
干预措施: Lenalidomide Accord 15 mg hard capsules (Drug)
Lenalidomide Mylan 20 mg hard capsules, Lenalidomide Mylan 25 mg hard capsules, Lenalidomide Accord 10 mg hard capsules, Lenalidomide Accord 20 mg hard capsules, Lenalidomide Mylan 10 mg hard capsules, Lenalidomide Accord 25 mg hard capsules, Lenalidomide Accord 5 mg hard capsules, Lenalidomide Accord 15 mg hard capsules, Lenalidomide Mylan 15 mg hard capsules, Lenalidomide Mylan 5 mg hard capsules
Comparator
干预措施: Lenalidomide Mylan 15 mg hard capsules (Drug)
Lenalidomide Mylan 20 mg hard capsules, Lenalidomide Mylan 25 mg hard capsules, Lenalidomide Accord 10 mg hard capsules, Lenalidomide Accord 20 mg hard capsules, Lenalidomide Mylan 10 mg hard capsules, Lenalidomide Accord 25 mg hard capsules, Lenalidomide Accord 5 mg hard capsules, Lenalidomide Accord 15 mg hard capsules, Lenalidomide Mylan 15 mg hard capsules, Lenalidomide Mylan 5 mg hard capsules
Comparator
干预措施: Lenalidomide Mylan 5 mg hard capsules (Drug)
Dexamethason 8 mg GALEN Tabletten, Fortecortin® 2 mg Tabletten
Comparator
干预措施: Dexamethason 8 mg GALEN Tabletten (Drug)
Dexamethason 8 mg GALEN Tabletten, Fortecortin® 2 mg Tabletten
Comparator
干预措施: Fortecortin® 2 mg Tabletten (Drug)
结局指标
主要结局
PFS as assessed by a validated computerized algorithm: time from randomization to confirmed progressive disease (per IMWG response criteria) or death, whichever occurs first.
PFS as assessed by a validated computerized algorithm: time from randomization to confirmed progressive disease (per IMWG response criteria) or death, whichever occurs first.
12-month MRD-negative CR rate: complete response or better (per IMWG response criteria) and MRD negative status, at the analysis time window of 12 months, prior to progressive disease or subsequent antimyeloma therapy (including autologous stem cell transplant)
12-month MRD-negative CR rate: complete response or better (per IMWG response criteria) and MRD negative status, at the analysis time window of 12 months, prior to progressive disease or subsequent antimyeloma therapy (including autologous stem cell transplant)
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (88)
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