CTRI/2022/05/042713尚未招募2 期
Phase 2, Randomized, Parallel, Open-Label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-AgentBelantamab Mafodotin (GSK2857916) in Participants with Relapsed or Refractory Multiple Myeloma (DREAMM-14) - DREAMM-14
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •18 or older, capable of giving signed informed consent
- •ECOG Performance Status 0-2
- •Histologically or cytologically confirmed diagnosis of: Multiple Myeloma as defined according to IMWG, 2014 criteria [Rajkumar, 2014], and:
- •Has undergone autologous stem cell transplant ( >100 days), or is considered transplant ineligible,
- •Has received at least 3 prior lines, including an anti-CD38 antibody and is refractory to an immunomodulatory agent and a proteasome inhibitor
- •Must have measurable disease
- •Serum M-protein >=0.5 g/dL (>=5 g/L), or
- •Urine M-protein >=200 mg/24h, or
- •Serum Free Light Chain (FLC) assay: Involved serum FLC level >=5 mg/dL (>=50 mg/L) and an abnormal serum FLC ratio ( <0.26 or >1.65) or
- •Prior treatment-related toxicities must be <= Grade 1, except for alopecia and Grade 2 neuropathy (CTCAE, V5)
- •Life expectancy of at least 6 months
- •Sex and Contraception/Barrier Requirements:
- •Female: Unless not a WOCBP, use highly effective contraceptive method (failure rate of <1% per year), preferably with low user dependency. During intervention & 4 months after last dose
- •Male: Be abstinent from heterosexual intercourse OR agree to use a male condom and female partner to use an additional highly effective contraceptive method throughout study treatment including the 6-month follow-up period even if they have undergone a successful vasectomy
排除标准
- •Symptomatic amyloidosis, active POEMS syndrome, active plasma cell leukemia
- •Corneal epithelial disease, except nonconfluent superficial punctate keratitis
- •Evidence of active mucosal or internal bleeding
- •Presence of renal or liver condition, active infection requiring treatment, serious or unstable medical conditions, other malignancies, protocol-defined cardiovascular risk/disease, pregnancy/lactation (female), recent major surgery
- •Presence of HIV, Hepatitis B, Hepatitis C (as per protocol requirements)
- •Prior therapy with:
- •Systemic MM treatment <= 14 days or 5 half-lives, whichever is shorter
- •Steroids (equivalent to >= 60 mg prednisone daily for >=4 days) within 14 days
- •BCMA-targeted therapy, or Hypersensitivity to study treatment
- •Investigational drug (<= 14 days or 5 half-lives), monoclonal antibody (<= 30 days), any ADC
- •Plasmapheresis within 7 days of first dose
- •Anti-MM mAb within 30 days of first dose
- •Allogenic stem cell transplant (syngeneic transplant will be allowed if no GVHD)
- •Inadequate bone marrow reserve or organ functions as demonstrated by any of the following:
- •Absolute neutrophil count <1.0Ã?109/L
- •Hemoglobin <8 g/dL
- •Platelet count <50Ã?109/L
- •Spot urine (albumin/creatinine ratio) >500 mg/g (56 mg/mmol)
- •eGFR <30mL/min/1.73 m2 (as calculated by Modified Diet in Renal Disease equation)
- •Note: Laboratory results obtained during screening must be used to determine eligibility criteria. In situations where laboratory results are outside the permitted range, the investigator may re-test the participant and the subsequent within range screening result may be used to confirm eligibility.
- •Note: Supportive care as needed, including transfusion of blood products or growth factors, prior to or during the study is allowed
研究者
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