NCT06711705招募中2 期
Phase II MRD-Adapted Study of Elranatamab in Relapsed/Refractory
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
- 33
- 试验地点
- 1
- 主要终点
- MRD negativity rate as best response
研究概览
简要总结
This study evaluates the efficacy of elranatamab alone in patients with relapsed and/or refractory Multiple myeloma who has previously received 1 to 3 combinations of treatment.
详细描述
Phase II study of elranatamab in patients with relapsed/refractory multiple myeloma who has received 1 to 3 prior lines of therapy. Patients may enter treatment-free observation period if they have a sustained MRD negative response for greater than 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Prior diagnosis of relapsed/refractory MM and have received 1 to 3 prior lines of therapy as defined by the IMWG criteria (Rajkumar et al., 2014) including anti-CD38 monoclonal antibody, proteosome inhibitor (PI), and immunomodulatory drug (IMiD), and BCMA-directed chimeric antigen receptor T-cell (CAR T-cell) therapy
- •Refractory is defined as having disease progression while on therapy or within 60 days of last dose in any line, regardless of response.
- •If participant has not received BCMA-directed CAR T-cell therapy, must be ineligible for CAR T-cell therapy or deferred such treatment by participant
- •Aged greater or equal to 18 years
- •Measurable disease as defined by any of the following:
- •Serum M-protein level ≥ 0.5 g/dL by serum protein electrophoresis (SPEP), or
- •Urine M-protein ≥ 200mg/24 hours by urine protein electrophoresis (UPEP), or
- •Involved serum free light chain ≥ 10 mg/dL (≥100mg/L) AND an abnormal serum free light chain ratio in patients without measurable disease in the serum or urine
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Adequate hematological function defined as
- •Absolute neutrophil count (ANC) ≥1,000/mm3 (G-CSF not permitted for at least 1 week prior to the first dose of elranatamab)
- •Hemoglobin ≥8.0 g/dL (transfusion support is permitted if completed at least 1 week prior to planned start of dosing)
- •Platelet count ≥75,000/mm3 or ≥50,000/mm3 if >50% involvement with plasma cells in the screening bone marrow (transfusion support is permitted if completed at least 1 week prior to planned start of dosing)
- •Adequate renal function with estimated creatinine clearance (CrCl) ≥30 mL/min as calculated using Cockcroft-Gault equation.
- •Adequate liver function defined as
- •Aspartate and alanine aminotransferase (AST and ALT) ≤2.5 x upper limit of normal (ULN); ≤5.0 x ULN if there is liver involvement by the tumor.
- •Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN in case of bone metastasis).
- •Total bilirubin ≤2.0 mg/dL, except in patients with Gilbert Syndrome who must have a total bilirubin less than 3.0 mg/dL.
- •Able to receive outpatient treatment of elranatamab by meeting the following criteria:
- •Lives within 30minutes from the site of medication administration
- •Reliable caregiver present, who is able to watch participant continuously for at least until 48 hours after administration of first full treatment dose
- •No history of grade 3-4 CRS or grade 3-4 ICANS from other immune effector cell or bispecific antibody therapies
- •Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
- •Serum pregnancy test (for females of childbearing potential) negative at screening.
- •a. Female patients of non-childbearing potential must meet at least 1 of the following criteria: i. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.
- •ii. Have undergone a documented hysterectomy and/or bilateral oophorectomy. iii. Have medically confirmed ovarian failure. b. All other female patients (including female patients with tubal ligations) are considered to be of childbearing potential.
- •Agreement to adhere to Lifestyle Considerations (see section 5.3 and Appendix 2) throughout study duration
排除标准
- •Subjects with smoldering multiple myeloma, IgM multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, POEMS syndrome, and primary and secondary plasma cell leukemia, defined as circulating plasma cells ≥ 5%
- •Extramedullary relapse who does not meet criteria for measurable disease as above
- •Active malignancy other than Multiple Myeloma requiring treatment in the past 3 years, with the exception of successfully treated non-metastatic squamous or basal skin carcinoma
- •Known CNS involvement by multiple myeloma
- •Active, uncontrolled autoimmune disorders
- •Active uncontrolled infection. Active infections must be resolved and/or controlled at least 14 days prior to enrollment.
- •Radiation therapy within 2 weeks prior to study entry (bone lesions requiring radiation may be treated with limited [ie, ≤25% of bone marrow in field] radiation therapy during this period).
- •Last systemic treatment within 2 weeks or 5 half lives, whichever is shorter. Subjects can receive a maximum of 160mg of dexamethasone or equivalent during screening, but at least 7 days prior to start of therapy.
- •Last radiation treatment to multiple sites within 2 weeks and single site within 1 week
- •History of autologous stem cell transplant within 100 days prior to study enrollment.
- •History of allogeneic transplant within 1 year prior to study enrollment or active graft versus host disease.
- •On immunosuppressive therapy for concurrent comorbid conditions
- •Other major uncontrolled medical comorbidities that may put patients at risk of serious adverse event with treatment with study medication.
- •Clinically significant, uncontrolled cardiac disease
- •Grade ≥2 peripheral sensory or motor neuropathy
- •History of Guillan-Barre syndrome
- •Other surgical (including major surgery within 14 days prior to enrollment) or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
- •Pregnancy or lactation
- •Known or suspected hypersensitivity to the study intervention or any of its excipients.
研究组 & 干预措施
Elranatamab
Experimental
Treatment with elranatamab
干预措施: Elranatamab (Drug)
结局指标
主要结局
MRD negativity rate as best response
时间窗: 1 year of starting treatment
MRD negativity rate as best response
次要结局
- Complete response rate(Within 1 year of treatment)
- Progression free survival(Through study completion, up to 5 years)
- Duration of response(Through study completion, up to 5 years)
- Quality of life (questionnaire and by EORTC QLQ-MY20 questionnaire)(Through study completion, up to 5 years)
- Safety (cytokine release syndrome, neurotoxicity, treatment-related adverse events)(Through study completion, on average 4 weeks (cytokine release syndrome, neurotoxicity); Through study completion, up to 5 years (treatment-related adverse events as assessed by CTCAE v5.0 ))
- Sustained MRD negativity rate at 10^-5(Through study completion, up to 5 years)
- Overall response rate(Within 1 year of treatment)
研究者
Ah-Reum "Autumn" Jeong
Assistant Clinical Professor, Medicine
University of California, San Diego
研究点 (1)
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