2023-506668-15-00招募中3 期
A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapy in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 131
- 试验地点
- 49
- 主要终点
- Progression Free Survival (PFS) with Progressive Disease (PD) assessed according to the IMWG (2016) response criteria, per IRC assessment
研究概览
简要总结
To evaluate the efficacy, safety, and tolerability of etentamig administered as monotherapy in adult subjects with RRMM who have received at least 2 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 mAb.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Adult individuals, male or female, ≥18 years old.
- •Subject must be eligible to receive the Investigator's choice SAT based on approved prescribing information, previous MM treatment history, and institutional guidelines.
- •Subjects must accept to be treated with one of the pre-specified Standard Available Therapies (SAT), based on Investigator's choice of local standard of care.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •Subjects must meet the laboratory parameters, as specified in the study protocol, within 2 weeks prior of the first dose of study drug.
- •Subjects must has a diagnosis of relapsed and/or refractory MM during or after the subject's last treatment
- •Subjects must have measurable disease within 28 days prior to randomization, defined as at lease 1 of the following: Serum monoclonal paraprotein (M-protein) ≥0.5 g/dL (≥5 g/L); Urine M-protein ≥200 mg/24 hours; In subjects without measurable serum or urine M-protein, serum FLC ≥100 mg/L (10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio.
- •Subject must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb.
- •Subject with known HIV will be permitted provided that the subject has an undetectable HIV viral load by standard clinical assays on antiretroviral medication (HAART) and is able to tolerate study treatment per Investigator's judgement.
排除标准
- •History of significant cardiovascular or pericardial disease, including uncontrolled angina, arrhythmia, recent myocardial infarction within 6 months of first dose, Class ≥3 New York Heart Association congestive heart failure.
- •Subjects have received BCMA-targeted therapy
- •Subjects have known central nervous system involvement of MM.
- •History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
- •Known allergies, hypersensitivities, or intolerance to constituents of the study drug (and its excipients) or derivatives.
- •Subjects have evidence of active hepatitis B (HbsAg positive) infection based on screening blood testing (HBsAg, antiHBc, antiHBs).
- •SAT-Specific Exclusion Criteria: Subject is not eligible to receive SAT if subject has an ongoing condition or history of a condition which is an exclusion per local (or applicable) approved label, package insert, and/or institutional guidelines for any single agent from SAT regimen.
- •Subjects have evidence of active hepatitis C infection based on screening blood testing.
- •Subject has any of the following conditions: - Non-secretory MM; - Active plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 × 109 /L circulating plasma cells by standard differential; - Waldenstrom's macroglobulinemia; - Light chain amyloidosis; - POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes); - Major surgery within 4 weeks prior to first dose or during planned study participation; or Acute infections within 14 days prior to first dose of study drug requiring therapy (antibiotic, antifungal, or antiviral).
- •SAT-Specific Exclusion Criteria: Subject is not eligible to receive Kd if subject has received prior carfilzomib therapy.
- •SAT-Specific Exclusion Criteria: Subject is not eligible to received SVd if: - Subject has received prior selinexor therapy; - Prior PI treatment is allowed provided that subject achieved ≥PR and > 6 months has elapsed since last PI, with no history of discontinuation due to ≥Grade 3 toxicity.
- •SAT-Specific Exclusion Criteria: Subject is not eligible to receive EloPd if subject has received prior elotuzumab or pomalidomide therapy.
- •Subject have a known active SARS-CoV-2 infection. If a subject has signs/symptoms suggestive of SARS-CoV- 2 infection, the subject must have a negative molecular (e.g., PCR) test or 2 negative antigen test results at least 24 hours apart.
- •History of clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the subject's participation in the study.
- •History of any malignancy within the past 3 years with the following exceptions: - Adequately treated in situ carcinoma of the cervix uteri or the breast; - Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; - Prostate cancer Gleason Grade 6 or lower AND with stable PSA levels on or off treatment; - Previous malignancy with no evidence of disease confirmed and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study.
结局指标
主要结局
Progression Free Survival (PFS) with Progressive Disease (PD) assessed according to the IMWG (2016) response criteria, per IRC assessment
Progression Free Survival (PFS) with Progressive Disease (PD) assessed according to the IMWG (2016) response criteria, per IRC assessment
Overall Response Rate (ORR) per IMWG (2016) response criteria (defined as PR + VGPR + CR + sCR) per IRC assessment
Overall Response Rate (ORR) per IMWG (2016) response criteria (defined as PR + VGPR + CR + sCR) per IRC assessment
次要结局
- Overall Survival (OS)
- Rate of ≥VGPR per IRC assessment
- Rate of ≥CR per IRC assessment
- Rate of MRD negativity with ≥CR, defined as achievement of CR or better by IMWG (2016) response criteria (per IRC assessment) and MRD negative status as assessed by NGS Adaptive Clonoseq at 10- 5 threshold
- Change from baseline at 6 months in disease symptoms as measured by the disease symptoms domain of the EORTC QLQ-MY20
- Change from baseline at 6 months in physical functioning as measured by the physical functioning domain of the EORTC QLQ-C30
- Time to response (TTR) per IRC assessment
- Duration of response (DoR) per IRC assessment
- Time to Disease Progression (TTP) per IRC assessment
- Time to Next Therapy (TTNT)
- Event free survival (EFS)
- Patient Reported Outcomes (PROs): Change from baseline in the score of remaining scales and items of the EORTC QLQ-C30 and EORTC QLQ-MY20, PROMIS Fatigue SF 7a, EQ-5D-5L, PGIS; scores/frequencies of PGIS, PGIC and select items of the PRO-CTCAE
- Skeletal-related event (SREs), defined as presence of any of the following events: - spinal cord compression; - pathologic fracture; - surgery to bone; - radiation to bone
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (49)
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