CTIS2022-500453-16-00招募中1 期
Randomized phase II trial for patients with newly diagnosed low-risk multiple myeloma to evaluate the benefit of 6 cycles of isatuximab with lenalidomide/bortezomib/dexamethasone (I-VRD) followed by maintenance therapy with lenalidomide and isatuximab randomized in comparison with therapy consisting of 3 cycles of I-VRD followed by one cycle of high-dose therapy and maintenance therapy with lenalidomide and isatuximab - UZL22_01
niversity Medical Centre Schleswig-Holstein0 个研究点目标入组 100 人开始时间: 2022年7月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •newly diagnosed, untreated, symptomatic, documented myeloma (according to the revised CRAB criteria 2014) with clonal bone marrow (BM) plasma cells =10% or biopsy-proven osseous or extramedullary plasmacytoma and any one or more of the following myeloma defining events: I.Hypercalcemia: serum calcium >0,25 mmol/L (>1 mg/dl) higher than the upper limit of normal or >2,75 mmol/L (>11 mg/dL); II.Renal insufficiency: serum creatinine >177 µmol/l (>2 mg/dl); III.Anemia: hemoglobin value of >20 g/l below the lower limit of normal, or a hemoglobin value lower than 10g/dl; IV.Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT; V.Clonal BM plasma cell percentage =60%; VI.Involved: uninvolved serum free light chain ratio =100; VII.>1 focal lesions on MRI examination, Subjects must have adequate vascular access for leukapheresis, A male participant must agree to use contraception during the intervention period and for at least 5 months after the last dose of isatuximab treatment and refrain from donating sperm during this period. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: i)Not a Female of childbearing potential (FCBP), OR ii)A FCBP who must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 28 days prior to and again within 24 hours prior to starting study medication and then every 21 days during each cycle of induction as well as experimental arm consodilation and every 28 days during maintenance therapy and other therapy cycles and must either commit to continue abstinence from heterosexual intercourse or apply a highly effective method of birth control during the intervention period and for at least 5 months after the last dose of isatuximab treatment. In case of more frequent menstruation, a test will be applied every 14 days. In case of unexpected heavy bleeding or delay of menstruation, additional tests will be applied. Of note: contraception duration should take also into consideration any backbone therapy. All females: Must understand the damages and hazards lenalidomide can cause to an unborn fetus and the necessary precautions associated with the use of lenalidomide. Females of childbearing potential (FCBPs) must understand the need for effective contraception, without interruption. [...], All subjects must: I.Agree to abstain from donating blood while taking lenalidomide, during dose interruptions and for at least 5 months after the last dose of lenalidomide and/or isatuximab. II.Agree never to give lenalidomide to another person. III.Agree to return all unused lenalidomide capsules to the investigator (with exception of prescribed lenalidomide capsules) IV.Be aware that no more than a 28-day lenalidomide supply may be dispensed with each cycle of lenalidomide during induction and consolidation therapy and be prescribed during maintenance therapy., Presence of measurable disease: I.Serum M-protein = 0.5 g/dL or urine M-protein = 200 mg/24 hours. II.Involved FLC level = 10 mg/dl, provided sFLC ratio is abnormal, R-ISS stage I, Standard gene expression pattern of isolated plasma cell based on SKY92 GEP assay, Must be = 18 and =70 years at the time of signing the informed consent form, Must be able to adhere to the study visit schedule and other protocol requirements in the investigator's opinion, WHO performance status 0-2 (WHO=2 is allowed on
排除标准
- •Direct Coombs test positive hemolytic anemia, An inadequate pulmonary function defined as oxygen saturation (Sa02) < 92 % on room air, Known to be HIV+ or to have uncontrolled or active hepatitis A, B, or C infection [...], Subject with prior history of malignancies, other than MM, unless the subject has been free of the disease for = 5 years, Subjects with severe polyneuropathy with accompanying pain, Hypersensitivity or allergy against any of the study drugs, Contraindications against any of the study drugs as outlined in the Investigator brochure or equivalent, Prisoners or subjects who are legally institutionalized, or those unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions, Participation in another interventional clinical trial during this trial or within 4 weeks before entry into this trial. There may be exceptions at the discretion of the (coordinating) investigator, Active systemic infection and severe infections requiring treatment with a parenteral administration of antibiotics, Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose the patient to excessive risk or may interfere with compliance or interpretation of the study results, Involvement of the central nervous system (CNS), Hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents, History or presence of clinically relevant CNS pathology such as clinically relevant epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis, Subject with active or history of plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome or clinically significant amyloidosis, Patients having nonsecretory MM, Systemic AL amyloidosis (with exception of AL amyloidosis of BM), Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy for myeloma treatment or benign diseases, such as nonmalignant thyroid diseases. (Note: patients may have received a cumulative dose of up to 320 mg of dexamethasone or equivalent as emergency therapy.) Previous therapy due to smouldering myeloma or a single dose of bortezomib may be acceptable. In this case the coordinating investigator or his deputy has to be consulted prior to inclusion, Patients with any of the following laboratory abnormalities: I.Absolute neutrophil count (ANC) < 1,000/µL. II.Platelet count < 50,000 / µL (Platelet transfusions are not permitted to improve platelet count one week prior to study inclusion.) III.Serum Creatinine Clearance (CrCl) < 30 mL/min / 1,73m2. IV.Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN) (unless due to liver infiltration by myeloma cells), serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert’s syndrome. V.International ratio (INR) or partial thromboplastin time (PTT) > 1.5 × ULN, or history of Grade = 2 hemorrhage within 30 days, or subject requires ongoing treatment with c
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