PHASE III STUDY OF ISATUXIMAB-CARFILZOMIB-LENALIDOMIDE-DEXAMETHASONE (Isa-KRd) VERSUS CARFILZOMIB-LENALIDOMIDE-DEXAMETHASONE (KRd) IN NEWLY DIAGNOSED MYELOMA PATIENTS ELIGIBLE FOR AUTOLOGOUS STEM CELL TRANSPLANTATION (IsKia TRIAL) - EMN24/HOVON 503 MM

Stichting European Myelooma Network - EMN, contact pers P. Sonneveld0 个研究点目标入组 70 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 70

研究概览入排标准研究者记录与标识符相似试验

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 99（—）

入选标准

•1. Patient with newly diagnosed multiple myeloma and eligible to ASCT, for whom
•the standard treatment it is not, according to investigator, the best treatment
•2. Patient is, in the investigator*s opinion, willing and able to comply with
•the study visits and procedures required per protocol.
•3. Patient has provided written informed consent. Subject does not have kind of
•condition that, in the opinion of the Investigator, may compromise the ability
•of the subject to give written informed consent and patient is, in the
•investigator(s) opinion, willing and able to comply with the protocol
•requirements.
•4. Monoclonal plasma cells in the bone marrow >=10% or presence of a biopsy
•proven plasmacytoma and documented multiple myeloma satisfying at least one of
•the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignancy
•CRAB criteria:
•- Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than upper limit
•of normal (ULN) or >2.75 mmol/L (>11 mg/dL)
•- Renal insufficiency: creatinine clearance <40mL/min or serum creatinine >177
•µmol/L (>2 mg/dL)
•- Anemia: hemoglobin >2 g/dL below the lower limit of normal or hemoglobin <10
•- Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or
•Biomarkers of Malignancy:
•- Clonal bone marrow plasma cell percentage >=60%
•- Involved: uninvolved serum FLC ratio >=100
•- >1 focal lesion on magnetic resonance imaging (MRI) studies
•5. Patient is 18 - 70 years old and is eligible for autologous stem cell
•transplantation
•6. Patient has measurable disease as defined by any one of the following:
•- Serum monoclonal paraprotein (M-protein) level >=1.0 g/dL or urine M-protein
•level >=200 mg/24 hours; or
•- Light chain multiple myeloma without measurable disease in the serum or the
•urine: Serum immunoglobulin FLC >=10 mg/dL and abnormal serum immunoglobulin
•kappa lambda FLC ratio.
•7. Life expectancy >= 3 months
•8. ECOG status <=2
•9. Clinical laboratory values meeting the following criteria during the
•Screening Phase:
•o Adequate hepatic function, with serum ALT <= 2.5 times ULN, AST <= 2.5 x the
•o Serum direct bilirubin <= 1.5 ULN (except in subjects with congenital
•bilirubinemia, such as Gilbert syndrome, direct bilirubinemia <= 1.5 ULN)
•o Absolute neutrophil count (ANC) >= 1.0 × 109/L
•o Platelet count >= 75× 109/L (>= 50× 109/L if myeloma involvement in the bone
•marrow is > 50%) and no platelet infusion in the 1 week prior to screening
•platelet count
•o Creatinine clearance (CrCl) >= 30 mL/minute. Creatinine clearance should be
•calculated using eGFR (Modified Diet in Renal Disese [MDRD])
•o Corrected serum calcium <= 13.5 mg/dL (3.4 mmol/L)
•o LVEF >= 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method
•of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not
•10. Females of childbearing potential (FCBP)* complies with the conditions of
•the Pregnancy Prevention Plan, including confirmation that she has an adequate
•level of understanding and must agree to ongoing pregnancy testing and to
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排除标准

•1. Previous treatment with anti-myeloma therapy (does not include radiotherapy,
•biphosphonates, or a single short course of steroid <= to the equivalent of
•dexamethasone 40 mg/day for 4 days).
•2. Patients with non-secretory MM unless serum free light chains are present
•and the ratio is abnormal or a plasmacytoma with minimum largest diameters of >
•3. Patients with plasma cell leukemia, amyloidosis, Waldenstrom Disease, POEMS
•4. Meningeal involvement of multiple myeloma
•5. Patient ineligible for autologous transplantation
•6. Pregnant or lactating females
•7. Acute active infection requiring treatment (systemic antibiotics,
•antivirals, or antifungals) within 14 days prior to randomization
•8. Known human immunodeficiency virus infection (HIV)
•9. Active hepatitis A, B or C infection. Hepatitis C infection (subjects with
•hepatitis C that achieve a sustained virologic response after antiviral therapy
•are allowed), or hepatitis B infection (subjects with hepatitis B surface
•antigen or core antibody that achieve sustained virologic response with
•antiviral therapy are allowed). Tests to be performed if required per local
•country regulations (in Czech Republic
•testing for HIV and hepatitis B and C is required at screening). In fact it is
•not possible to avoid the risk of virological reactivation with the study
•treatments.
•Uncontrolled or active HBV infection: Patients with positive HBsAg and/or HBV
•- Patient can be eligible if anti-HBc IgG positive (with or without positive
•anti-HBs) but HBsAg
•and HBV DNA are negative. If anti-HBV therapy in relation with prior infection
•was started
•before initiation of IMP, the anti-HBV therapy and monitoring should continue
•throughout the
•study treatment period.
•- Patients with negative HBsAg and positive HBV DNA observed during screening
•period will
•be evaluated by a specialist for start of anti-viral treatment: study treatment
•could be proposed
•if HBV DNA becomes negative and all the other study criteria are still met.
•Active HCV infection: positive HCV RNA and negative anti-HCV
•- Patients with antiviral therapy for HCV started before initiation of IMP and
•positive HCV
•antibodies are eligible. The antiviral therapy for HCV should continue
•throughout the treatment
•period until seroconversion.
•- Patients with positive anti-HCV and undetectable HCV RNA without antiviral
•therapy for HCV
•are eligible.
•10. Unstable angina or myocardial infarction within 4 months prior to
•randomization, NYHA Class III or IV heart failure, uncontrolled angina,
•uncontrolled hypertension, (Uncontrolled hypertension, defined as an average
•systolic blood pressure >= 160 mmHg or diastolic >= 100 mmHg despite optimal
•treatment, in the last 5 years pulmonary embolia, history of severe coronary
•artery disease, severe uncontrolled ventricular arrhythmias, sick sinus
•syndrome, or electrocardiographic evidence of acute ischemia or Grade 3
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研究者

发起方

Stichting European Myelooma Network - EMN, contact pers P. Sonneveld

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