Isatuximab in combination with Lenalidomide-Dexamethasone compared to Lenalidomide-Dexamethasone in elderly patients (aged ≥70 years) with newly diagnosed myeloma: a randomized phase II study (SGZ-2019-12650)

Arbeitsgemeinschaft Medikamentoese Tumortherapie gGmbH12 个研究点分布在 2 个国家目标入组 138 人开始时间: 2024年10月11日最近更新: 2025年4月28日

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 138
试验地点: 12
主要终点: To evaluate the proportion of patients with MRD negativity (defined by NGF (next generation flow) at 10^-5) after end of induction treatment in the two arms.

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To demonstrate the benefit of isatuximab in combination with lenalidomide and low-dose dexamethasone followed by isatuximab and lenalidomide maintenance therapy in increasing the proportion of patients with MRD negativity as compared to lenalidomide and low-dose dexamethasone followed by lenalidomide maintenance treatment in patients with newly diagnosed multiple myeloma (NDMM).

入排标准

年龄范围: 65 years 至 65+ years（65+ Years）
接受健康志愿者: 否

入选标准

•Age ≥ 70 years
•Able to provide written informed consent in accordance with federal, local, and institutional guidelines
•Patients must have newly diagnosed, symptomatic multiple myeloma with evidence of measurable disease (assessed within 21 days prior to randomization) o Serum M protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or o Urine M protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or o In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) ≥100 mg/L (involved light chain) and an abnormal FLC ratio
•No prior treatment for multiple myeloma
•Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
•Patients at cardiac risk (NYHA >ll) or pre-existing coronary heart disease, or any other clinically relevant cardiac complication) should be scheduled for a baseline ECHO and can only be included if the LVEF is >40%
•Adequate organ and bone marrow function within the 21 days prior to randomization defined by: o Bilirubin < 2 times the upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN o Absolute neutrophil count (ANC) ≥ 750/mm3 (growth factor support for max 3 days allowed to achieve this value) o Hemoglobin >8.0 g/dL (Use of erythropoietic stimulating factors and red blood cell [RBC] transfusion per institutional guidelines is allowed, however the most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.) o Platelet count >50,000/mm3 o Calculated or measured creatinine clearance (CrCl) of ≥30 mL/min/1.73m2 (Calculation should be based on the MDRD formula (age, gender, black/non- black, weight, height)

排除标准

•ECOG status >2
•Extended field radio therapy (more than 3 fields) within the 21 days prior to randomization
•Contraindication to isatuximab, dexamethasone, lenalidomide or any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs
•Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, acute diffuse infiltrative pulmonary disease, pericardial disease, or myocardial infarction within 4 months prior to enrolment
•Active infection within the 14 days prior to randomization requiring systemic antibiotics and/or antiviral therapy
•Uncontrolled hypertension or uncontrolled diabetes despite medication
•Significant neuropathy (Grade 2 with pain or Grade 3 or higher) within the 14 days prior to randomization
•Known cirrhosis
•Known human immunodeficiency virus (HIV) seropositivity or active hepatitis C or hepatitis B infection (subjects with past hepatitis B virus [HBV] infection or resolved HBV infection defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti HBc] antibody test are eligible; subjects positive for hepatitis C virus [HCV] antibody are eligible only if polymerase chain reaction [PCR] is negative for HCV RNA.)
•Participation in another interventional study within the 28 days prior to randomization
•Major surgery (except kyphoplasty) within the 28 days prior to randomization
•Patients unlikely to tolerate Rd
•Any other clinically significant medical disease or social condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent, be compliant with study procedures, or provide accurate information.
•POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
•Plasma cell leukemia (> 2.0 x 10^9/L circulating plasma cells by standard differential)
•Myelodysplastic syndrome
•Smoldering Myeloma and MGUS
•Second malignancy within the past 5 years except: o Adequately treated basal cell or squamous cell skin cancer o Carcinoma in situ of the cervix o Prostate cancer ≤ Gleason score 6 with stable prostate-specific antigen (PSA over 12 months) o Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins) o Treated medullary or papillary thyroid cancer o Other tumors with low risk of recurrence/metastases and/or early stage R0 surgery
•History of or current amyloidosis
•Glucocorticoid therapy within the 14 days prior to randomization that exceeds an accumulated dose of 160 mg dexamethasone or 1000 mg prednisone

结局指标

主要结局

To evaluate the proportion of patients with MRD negativity (defined by NGF (next generation flow) at 10^-5) after end of induction treatment in the two arms.

次要结局

To evaluate the proportion of patients with MRD negativity (defined by NGF at 10^-5) after 12 months (13 cycles) of maintenance treatment.
To evaluate the Overall Response Rate (ORR), Partial Response (PR), Very Good Partial Response (VGPR) and Complete Response (CR) as per International Myeloma Working Group (IMWG) criteria in each arm.
To compare the Progression-free (PFS) and Overall Survival (OS) between the two arms.
To evaluate the Time to Progression (TTP) in each arm.
To evaluate the PFS in high risk cytogenetic population defined as patients carrying a) del(17p), t(4;14), t(14;16) in each arm and b) the same aberrations plus amp1q21.
To evaluate the Duration of Response in each arm.
To evaluate safety in both treatment arms.
To assess disease-specific and a generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility and health status.
To evaluate PFS of potential second line therapy.

研究者

发起方

Arbeitsgemeinschaft Medikamentoese Tumortherapie gGmbH

申办方类型

Hospital/Clinic/Other health care facility

责任方

Principal Investigator

主要研究者

Clinical Trials Lead Manager

Scientific

Arbeitsgemeinschaft Medikamentoese Tumortherapie gGmbH

研究点 (12)

Loading locations...

相似试验

进行中（未招募）

1 期

Isatuximab in combination with Lenalidomide-Dexamethasone compared to Lenalidomide-Dexamethasone in elderly patients (aged =70 years) with newly diagnosed myeloma: a randomized phase II study (SGZ-2019-12650)ewly diagnosed, symptomatic multiple myeloma in elderly patientsMedDRA version: 16.1Level: HLTClassification code 10028229Term: Multiple myelomasSystem Organ Class: 100000004851

EUCTR2020-004972-17-ATAGMT gGmbH198

招募中

1 期

EUCTR2020-004972-17-GRAGMT gGmbH198

进行中（未招募）

不适用

Isatuximab in combination with lenalidomide and dexamethasone in high-risk smoldering multiple myeloma (ITHACA)

jRCT2031210017Sanofi K.K.300

招募中

3 期

A Phase 3 Randomized Study of Loncastuximab Tesirine Combined with Rituximab Versus Immunochemotherapy in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS 5)

2023-503916-33-00ADC Therapeutics S.A.277

招募中

1 期

Trastuzumab Deruxtecan, and pembrolizumab in participants with Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer

2023-509866-39-00Daiichi Sankyo Inc.76