KCT0009561尚未招募Unknown
A Prospective Investigator-initiated Study to explore the optimal dose of lenalidomide in combination therapy for patients with Multiple Myeloma Featuring Renal Dysfunction
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 19(Year) 至 72(Year)（—）
- 性别
- All
入选标准
- •Male or female aged 19 to less than 72 years.
- •Patients with multiple myeloma according to IMWG criteria (19. Miscellaneous for safe and scientifically valid clinical trials).
- •Patients diagnosed with multiple myeloma who meet the following criteria (all must be met):
- •Monoclonal plasma cells in the bone marrow.
- •=10% monoclonal plasma cells confirmed by tissue examination.
- •Patients with evaluable multiple myeloma and one or more of the following:
- •i. Serum M-protein = 0.5 g/dL or urine M-protein = 200 mg/24 hours.
- •ii. IgA multiple myeloma: Serum M-protein = 0.5 g/dL or urine M-protein = 200 mg/24 hours.
- •iii. Light chain multiple myeloma: Serum free light chain (sFLC) = 100 mg/L and abnormal serum kappa/lambda FLC ratio.
- •Patients starting or receiving one of the following immunotherapy treatments for multiple myeloma:
- •I. Lenalidomide-containing combination therapy for multiple myeloma:
- •(1) Lenalidomide-Dexamethasone
- •(2) Daratumumab-Lenalidomide-Dexamethasone
- •(3) Bortezomib-Lenalidomide-Dexamethasone
- •(4) Ixazomib-Lenalidomide-Dexamethasone
- •(5) Carfilzomib-Lenalidomide-Dexamethasone
- •II. Maintenance therapy after autologous hematopoietic stem cell transplantation:
- •(6) Lenalidomide monotherapy
- •*The 6 lenalidomide-based therapeutic regimens listed above are currently covered by health insurance in the Korean medical field as combination therapy or monotherapy.
- •Presence of renal dysfunction: eGFR < 50 mL/min.
- •Patients with adequate liver function (all must be met):
- •Serum total bilirubin less than 2 times the upper limit of normal (except in cases of Gilbert's syndrome, less than 3 times the upper limit of normal).
- •AST/ALT less than 2.5 times the upper limit of normal.
- •Eastern Cooperative Oncology Group Performance Status 0-2.
- •Normal cardiac function (Ejection fraction =45%).
- •Adequate bone marrow function (all must be met)*:
- •Neutrophil count = 1,000/µL.
- •Platelet count = 70,000/µL.
- •Hemoglobin = 9 g/dL.
- •*Allowance for application of granulocyte colony-stimulating factor or blood transfusions at screening or before screening.
- •For female participants:
- •Postmenopausal women with amenorrhea for = 1 year.
- •Pre-menopausal women with negative pregnancy test before treatment initiation (at the time of screening) and who can maintain contraception during the study period [limited to pre-menopausal women or women with amenorrhea for less than 1 year (within 1 year after menopause)].
- •*During the consent process for fertile women, participants are informed of contraception methods such as natural cycle methods and abstinence according to the Catholic ideology of the hospital.
排除标准
- •Asymptomatic smoldering multiple myeloma, active plasma cell leukemia, monoclonal gammopathy of undetermined significance (MGUS), amyloidosis or multiple myeloma involving the central nervous system.
- •Active cardiovascular dysfunction.
- •HIV positive.
- •Active hepatitis A, B*, or C.
- •*May participate if evidence of hepatitis B (HBV) infection exists but HBV DNA is not detected through antiviral therapy.
- •Currently undergoing treatment or requiring treatment for any cancer other than multiple myeloma.
- •History of any cancer other than melanoma or in situ carcinoma of the cervix uteri that has been cured within the past 5 years.
- •Peripheral neuropathy with severity grade 3 or above or peripheral neuropathy symptoms with severity grade 2 or above accompanied by pain.
- •Participation in another clinical trial involving administration of an anti-neoplastic agent within the past 3 weeks.
- •Concurrent severe mental illness making participation in the study difficult.
- •Pregnant women.
研究者
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A Prospective Investigator-initiated Study for dose-finding of lenalidomide in Multiple Myeloma (MM) Patients with Impaired Renal FunctioKCT0008994The Catholic University of Korea, Seoul St. Mary's Hospital30