A Phase 2, Multicenter, Open Label, Non-randomized Study to Evaluate the Efficacy and Safety of Extended Dosing of Belantamab Mafodotin in Different Combinations With Standard of Care Regimens in Participants With Relapsed-refractory Multiple Myeloma (DREAMM-15)
概览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Overall Response Rate (ORR)
概览
简要总结
This study is for adults with multiple myeloma (a type of blood cancer) that has come back after being treated earlier or isn't responding to the current treatment.
The main goal is to find out if the study drug, belantamab mafodotin, given less often (on an extended schedule) with other cancer medicines, can still treat the cancer effectively while causing fewer side effects, especially those affecting the eyes. The study will also look at how well the treatment works overall and how safe it is when administered to the participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Applicable to All Arms - BPd, BVd, BKd:
- •Male or female, 18 years or older (at the time consent is obtained).
- •Have a confirmed diagnosis of Multiple Myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status of zero to
- •Have been previously treated with at least 1, but no more than 2, prior lines of MM therapy and must have documented disease progression during or after their most recent therapy.
- •Must have at least 1 aspect of measurable disease, defined as one the following:
- •Urine M-protein excretion ≥200 mg/24 h, or
- •Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or
- •Free Light Chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (\<0.26 or \>1.65) only if patient has no measurable urine or serum M spike.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Applicable for all (BPd, BVd, BKd):
- •Active plasma cell leukemia at Screening.
- •Symptomatic amyloidosis, including active Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma proliferative disorder, and Skin changes (POEMS).
- •Previous or concurrent invasive malignancy other than MM, except:
- •The disease must be considered medically stable for at least 2 years; or
- •The patient must not be receiving active therapy, other than hormonal therapy for this disease.
- •Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
- •Plasmapheresis within 7 days prior to the first dose of study intervention.
- •Patients after prior allogeneic stem cell transplant
研究组 & 干预措施
Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd)
干预措施: Belantamab mafodotin (Drug)
Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd)
干预措施: Pomalidomide (Drug)
Belantamab mafodotin + Bortezomib + Dexamethasone (BVd)
干预措施: Belantamab mafodotin (Drug)
Belantamab mafodotin + Bortezomib + Dexamethasone (BVd)
干预措施: Dexamethasone (Drug)
Belantamab mafodotin + Bortezomib + Dexamethasone (BVd)
干预措施: Bortezomib (Drug)
Belantamab mafodotin + Carfilzomib + dexamethasone (BKd)
干预措施: Belantamab mafodotin (Drug)
Belantamab mafodotin + Carfilzomib + dexamethasone (BKd)
干预措施: Dexamethasone (Drug)
Belantamab mafodotin + Carfilzomib + dexamethasone (BKd)
干预措施: Carfilzomib (Drug)
Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd)
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Up to approximately 52 months
ORR is defined as the percentage of participants with a confirmed partial response \[PR\] or better (i.e., PR, very good partial response (VGPR), complete response \[CR\], stringent complete response \[sCR\]). Responses will be assessed using International Myeloma Working Group (IMWG) criteria.
Overall Response Rate (ORR)
时间窗: Up to approximately 54 months
ORR is defined as the percentage of participants with a confirmed partial response \[PR\] or better (i.e., PR, very good partial response (VGPR), complete response \[CR\], stringent complete response \[sCR\]). Responses will be assessed using International Myeloma Working Group (IMWG) criteria.
次要结局
- Number of participants with adverse events (AEs), Serious adverse events (SAEs) by severity(Up to approximately 52 months)
- Number of participants with AEs leading to dose modifications or AEs leading to treatment discontinuation(Up to approximately 52 months)
- Number of Participants With Ocular Findings on Ophthalmic Examination by severity(Up to approximately 52 months)
- Complete Response Rate (CRR)(Up to approximately 52 months)
- Minimal Residual Disease (MRD) Negativity Rate(Up to approximately 52 months)
- Duration of Response (DoR)(Up to approximately 52 months)
- Proportion of participants showing concordance between patient-reported ocular symptoms and ophthalmic examination findings(Up to approximately 52 months)
- Complete Response Rate (CRR)(Up to approximately 54 months)
- Minimal Residual Disease (MRD) Negativity Rate(Up to approximately 54 months)
- Duration of Response (DoR)(Up to approximately 54 months)
- Number of participants with adverse events (AEs), Serious adverse events (SAEs) by severity(Up to approximately 54 months)
- Number of participants with AEs leading to dose modifications or AEs leading to treatment discontinuation(Up to approximately 54 months)
- Number of Participants With Ocular Findings on Ophthalmic Examination by severity(Up to approximately 54 months)
- Proportion of participants showing concordance between patient-reported ocular symptoms and ophthalmic examination findings(Up to approximately 54 months)