NCT04680468进行中（未招募）2 期
Phase 2 Study of Belantamab Mafodotin as Pre- and Post-autologous Stem Cell Transplant Consolidation and Maintenance for Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- MRD (minimal residual disease) negativity rate
研究概览
简要总结
This is a single-institution, single-arm, phase 2 study in which belantamab mafodotin (GSK2857916), an antibody-drug conjugate targeting B-cell maturation antigen (BCMA), will be administered to patients with multiple myeloma prior to and following high-dose melphalan and autologous stem cell transplantation (ASCT), in conjunction with standard lenalidomide maintenance. We hypothesize that administration of belantamab mafodotin as part of autologous stem cell transplant consolidation and maintenance will be safe, well tolerated, and efficacious in comparison to historical data.
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
- •Must be able to understand the study procedures and have signed written, informed consent.
- •Must be 18 years of age or older at enrollment.
- •Must have started therapy for active multiple myeloma within 12 months of enrollment.
- •Must have an ECOG performance status of 0-
- •Have received no more than 2 prior lines of induction therapy (induction regimen not specified by protocol), with no prior progressive disease by International Myeloma Working Group (IMWG) criteria.
- •Must be in at least a partial response (PR) but not in a complete response (CR) or better after at least 4 cycles of induction therapy, per IMWG consensus criteria.
- •Eligible by institutional criteria to receive melphalan at a dose of 200 mg/m
- •Eligible to receive lenalidomide maintenance therapy post-ASCT.
- •Adequate bone marrow and organ function at enrollment.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •Is not a woman of childbearing potential (WOCBP), OR
- •Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 4 months after the last dose of belantamab mafodotin and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
- •Male participants are eligible to participate if they agree to the following during belantamab mafodotin treatment and for 6 months after the last dose of belantamab mafodotin to allow for clearance of any altered sperm:
- •Refrain from donating sperm PLUS either:
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, OR Must agree to use contraception/barrier as detailed in the protocol.
- •All prior treatment-related toxicities must be grade 1 or less at the time of enrollment except for alopecia.
排除标准
- •Must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug.
- •Must not have received treatment with a monoclonal antibody within 28 days of receiving the first dose of study drug
- •Must not be simultaneously enrolled in any interventional clinical trial
- •Must not have amyloidosis or POEMS syndrome.
- •Must not be pregnant or lactating.
- •Must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, severe hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.
- •Must not have any evidence of active mucosal or internal bleeding
- •History of an active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfill other criteria.
- •Participant must not have evidence of cardiovascular risk, as defined in the protocol.
- •Must not have any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
- •Must not have invasive malignancies other than disease under study, unless the second malignancy has been definitively treated or has been medically stable for at least 2 years and, in the opinion of the principal investigator, will not affect the evaluation of the effects of clinical trial treatment.
- •Must not have an active infection requiring antibiotic treatment.
- •Any major surgery within the last 4 weeks prior to enrollment.
- •Must not have current corneal epithelial disease except mild changes in corneal epithelium
- •Must not have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment
- •Must not have evidence for active hepatitis B infection (i.e. positive hepatitis B surface antigen or nucleic acid-based testing) at screening or within 3 months prior to first dose of belantamab mafodotin.
- •Must not have positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.
- •Must not have evidence of active HIV infection.
研究组 & 干预措施
Belantamab mafodotin
Experimental
Patients receive Belantamab mafodotin 2.5 mg/kg by intravenous infusion on day -42 relative to autologous stem cell infusion (day 0), on day +60, and every 90 days thereafter, for up to 2 years following ASCT.
干预措施: Belantamab mafodotin (Drug)
结局指标
主要结局
MRD (minimal residual disease) negativity rate
时间窗: 12 months post-ASCT
Percentage of participants who have achieved minimal residual disease (MRD) negativity by next-generation sequencing (NGS) at 12 months post-autologous stem cell transplant (ASCT)
次要结局
- Overall survival(through study completion, approximately 3 years)
- Stem cell collection days(Following stem cell mobilization, about 6 weeks after enrollment)
- Dose reductions(through study completion, approximately 3 years)
- Progression-free survival(through study completion, approximately 3 years)
- Frequency of treatment-related adverse events(through study completion, approximately 3 years)
- Dose delays(through study completion, approximately 3 years)
- MRD Negativity Rate(at 3 and 24 months post-ASCT)
- Overall response rate(through study completion, approximately 3 years)
- Very good partial response (VGPR) or better rate(through study completion, approximately 3 years)
- Complete response (CR) or better rate(through study completion, approximately 3 years)
- Stem cell yield(Following stem cell mobilization, about 6 weeks after enrollment)
- Hematopoietic reconstitution post-ASCT(up to 30 days post-ASCT)
- Change from Baseline in Health-related quality of life (HRQoL) as assessed by Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) questionnaire(baseline through study completion, approximately 3 years.)
研究者
研究点 (1)
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