2025-524793-42-00招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 123
- 试验地点
- 37
- 主要终点
- Alive and free of treatment emergent ASTCT Grade ≥2 CRS without the use of additional intervening treatment for CRS of any grade.
研究概览
简要总结
To determine if the addition of tocilizumab as prophylaxis compared to placebo will mitigate CRS by using a single dose of tocilizumab, prior to ramantamig dosing.
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
- •Documented diagnosis of MM as defined by the criteria below: a. MM diagnosis according to the IMWG diagnostic criteria. b. Measurable disease at screening as assessed by local laboratory, defined by any of the following: i. Serum M-protein level ≥0.5 g/dL ii. Serum immunoglobulin FLC ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio iii. Urine M-protein level ≥200 mg/24 hours
- •Received at least 1 prior lines of antimyeloma therapy.
- •Relapsed or refractory disease as defined below: a. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed PD by the IMWG response criteria >60 days after cessation of treatment. b. Refractory disease is defined as failure to achieve a response (ie, PR or better) or confirmed PD by the IMWG response criteria during previous treatment or ≤60 days after cessation of treatment.
- •Have an ECOG performance status score of 0 to 2 at screening and immediately before the start of study treatment administration (Oken 1982). Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (eg, wheelchair-bound due to prior spinal cord injury) and not related to MM or associated therapy.
排除标准
- •Concurrent use of any other anticancer treatment (including non-palliative radiotherapy) or investigational agent. For participants who received an allogeneic stem cell transplant, the transplant must be dated at least 6 months before first dose of study treatment. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks before the start of study treatment administration without signs of graft-versus-host disease.Toxicity related to prior anticancer treatment must have resolved to Grade 1 or better (except alopecia, skin fibrosis or discoloration, dry mouth, hearing loss, endocrinopathy managed with replacement therapy, peripheral neuropathy, which must be Grade 2 or better).
- •Serious underlying medical conditions, such as: a. Evidence of active systemic viral, fungal, or bacterial infection requiring systemic antiviral, antifungal, or antimicrobial therapy. b. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment. EXCEPTION: Participants with vitiligo, Type I diabetes, or prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing are eligible regardless of when these conditions were diagnosed or treatment. c. Overt clinical evidence of dementia or altered mental status d. Any of the following within 6 months prior to first dose of study treatment: severe or unstable angina, myocardial infarction, seizure, major thromboembolic events (eg, pulmonary embolism, cerebrovascular accident [including TIA and stroke]), clinically significant ventricular arrhythmias or heart failure New York Heart Association functional classification Class III to IV. Uncomplicated deep vein thrombosis is not considered exclusionary.
- •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. The only allowed exceptions are: i. Any active malignancy (ie, that was not progressing nor requiring treatment change in the last 24 months and not considered at high risk of recurrence requiring systemic therapy. ii. malignancies treated within the last 24 months that are considered at very low risk for recurrence: a) Non-muscle invasive bladder cancer (solitary Ta-papillary urothelial neoplasm of low malignant potential or low-Grade <3 cm, no carcinoma in situ). b) Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone. c) Non-invasive cervical cancer. d) Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer (anti-hormonaltherapy is permitted). e) Localized prostate cancer (M0, N0) with a Gleason Score ≤7, treated locally only (Radical Prostatectomy/Radiotherapy/focal treatment). iii. Other malignancy that is considered cured with minimal risk of recurrence in consultation with the sponsor. NOTE: In the event of any questions, consult with the sponsor prior to enrolling a participant.
- •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.
研究组 & 干预措施
TOCILIZUMAB
Test
干预措施: TOCILIZUMAB (Drug)
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
Test
干预措施: IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM. (Drug)
JNJ-79635322, JNJ-79635322
Test
干预措施: JNJ-79635322 (Drug)
结局指标
主要结局
Alive and free of treatment emergent ASTCT Grade ≥2 CRS without the use of additional intervening treatment for CRS of any grade.
Alive and free of treatment emergent ASTCT Grade ≥2 CRS without the use of additional intervening treatment for CRS of any grade.
次要结局
- Treatment-emergent CRS of any ASTCT Grade, Grade ≥2, and Grade ≥3 by the end of Day28 from the ramantamig step-up dose, respectively. Treatment-emergent CRS of any ASTCT Grade, Grade ≥2, and Grade ≥3 during the course of ramantamig treatment. Re-occurrence of CRS with ASTCT Grade ≥2 after the initial occurrence of treatment-emergent Grade ≥2 CRS event, and re-occurrence of CRS for all Grades.
- ORR (PR or better response); CR or better response, VGPR or better response as defined by the IMWG response criteria. DOR TTR PFS TTNT
- AE occurrence and severityas well as cytopenia and infections, laboratory results, and other safety parameters.
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (37)
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