CTRI/2024/03/063867招募中3 期
A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of Monotherapy with BCD-264 and Darzalex® in Subjects with Relapsed and Refractory Multiple Myeloma - NI
JSC BIOCAD, Russia0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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
- •Subjects meeting all of the inclusion criteria may participate in this study:
- •1. Signed informed consent form to participate in the study and the subject’s ability to comply with the requirements of the clinical study protocol.
- •2. Age greater than or equal to 18 years at the time of signing of the informed consent form.
- •3. Documented diagnosis of multiple myeloma according to IMWG criteria: (1) Presence of greater than or equal to 10 % clonal plasma cells in bone marrow or presence of biopsy-proven bony/extramedullary plasmacytoma
- •(2) presence of one or more of the following symptoms
- •a) hypercalcemia: serum calcium level of more than 0.25 mmol/L (greater than 1 mg/dL) above the upper limit of normal (ULN) or greater than 11.0 mg/dL (greater than 2.75 mmol/L)
- •b) renal dysfunction: serum creatinine level greater than 2 mg/dL (greater than 177 µmol/L), creatinine clearance less than 40 mL/min
- •c) anemia: hemoglobin level more than 2 g/dL (20 g/L) below the lower limit of normal (LLN) or less than 10 g/dL (less than 100 g/L)
- •d) 1 or more osteolytic bone lesions on skeletal radiography, CT or PET-CT1
- •e) number of clonal plasmocytes in bone marrow greater than or equal to 60 %
- •f) involved ?/uninvolved ? serum free light chains (FLC) ratio: greater than or equal to 100 and concentration of involved ? FLC greater than or equal to 10 mg/dL
- •g) more than 1 focal lesions on MRI studies (size greater than or equal to 5 mm).
- •4. Measurable disease at screening: (1) M-protein in serum greater than or equal to 1.0 g/dL (10 g/L) or in 24-hour urine greater than or equal to 200 mg or
- •(2) light chain myeloma: serum involved ? FLC level greater than or equal to 10 mg/dL (100 mg/L) and abnormal kappa/lambda FLC ratio2.
- •5. Evidence of at least a partial response (PR) according to IMWG criteria (as assessed by the Investigator) to at least 1 prior line of therapy.
- •6. Subjects with relapsed and refractory multiple myeloma who previously received therapy with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy: (1) Relapsing myeloma: initial response to previous treatment, followed by confirmed progressive disease (PD) according to IMWG criteria more than 60 days after cessation of treatment
- •(2) refractory myeloma: less than 25 % reduction of M-protein or confirmed progressive disease (PD) according to IMWG criteria during the previous line of therapy or 60 days or less after cessation of treatment.
- •7. ECOG score 0–2.
- •8. Laboratory values at screening: (1) Absolute neutrophil count greater than or equal to 1000/µL (1.0 × 109/L); the use of G-CSF is allowed
- •(2) platelets greater than or equal to 50,000/µL (50 × 109/L) without transfusions within 7 days prior to laboratory testing
- •(3) hemoglobin greater than or equal to 7.5 g/dL (greater than or equal to 75 g/L) or greater than or equal to 5 mmol/L without transfusions within 7 days prior to laboratory testing; the use of recombinant human erythropoietin is allowed
- •(4) aspartate aminotransferase (AST) less than or equal to 2.5 × ULN
- •(5) alanine aminotransferase (ALT) less than or equal to 2.5 × ULN
- •(6) creatinine clearance greater than 20 mL/min/1.73 mm2 calculated using the CKD-EPI formula
- •(7) total bilirubin less than 2 × ULN (except for subjects with congenital bilirubinemia, for examp
排除标准
- •1. Subjects who received daratumumab or other anti-CD38 therapy.
- •2. Subjects treated for multiple myeloma within 2 weeks or 5 half-lives (whichever is longer) before the date of randomization, except for a short course of glucocorticoids (equivalent to 40 mg/day of dexamethasone for up to 4 days) as rescue treatment.
- •3. Autologous hematopoietic stem cell transplantation within 12 weeks prior to the date of randomization.
- •4. Allogeneic hematopoietic stem cell transplantation, regardless of timing.
- •5. Scheduled hematopoietic stem cell transplantation prior to progressive disease during this study.
- •6. Subjects with plasma cell leukemia (greater than 2 × 109/L of circulating plasma cells in peripheral blood), POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammapathy, skin lesions) or amyloidosis.
- •7. Subjects with Waldenstrom macroglobulinemia or other concomitant diseases with hyperproduction of monoclonal IgM (M-protein) in the absence of clonal proliferation of plasma cells with lytic bone involvement.
- •8. A history of other malignancies within the last 5 years, with the exception of squamous cell and basal cell skin cancer, cervical, breast carcinoma in situ, or other non-invasive malignancies that, in the Investigator’s opinion are considered to have been adequately treated and have a minimal risk of recurrence for 5 years.
- •9. Plasmapheresis within 28 days prior to randomization.
- •10. Clinical signs of meningeal involvement of multiple myeloma.
- •11. Concomitant diseases: COPD (with forced expiratory volume in 1 second less than 50 % of the required values), moderate or severe persistent asthma, or a history of asthma within the previous 2 years, or any uncontrolled asthma (subjects with controlled intermittent asthma or controlled mild persistent asthma may be included).
- •12. HIV, hepatitis B, hepatitis C.
- •13. Subjects with severe concomitant disorders, life-threatening acute complications of the indication treated (including massive pleural, pericardial, or peritoneal effusions requiring intervention, pulmonary lymphangitis, bleeding or organ perforation) at the time of signing of the informed consent form and during the screening period.
- •14. Concomitant diseases and/or conditions that may interfere with the procedures or results of the study or, in the Investigator’s opinion, increase the risks of participating in this study (e.g., active systemic infection, uncontrolled diabetes mellitus, acute diffuse interstitial lung disease).
- •15. Clinically significant cardiovascular disorders, including: (1) Uncontrolled hypertension (systolic blood pressure greater than 150 mmHg or diastolic blood pressure greater than 90 mmHg),
- •(2) stable angina pectoris, functional class III–IV,
- •(3) unstable angina and/or myocardial infarction within less than 6 months prior to randomization,
- •(4) chronic heart failure NYHA class III–IV,
- •(5) serious uncontrolled arrhythmia (CTCAE 5.0 grade greater than or equal to 2) or clinically significant ECG abnormalities,
- •(6) corrected QT interval according to Fridericia’s formula (QTcF) at screening (12-lead ECG) greater than 470 ms
- •16. Hypersensitivity, allergy or intolerability to monoclonal antibodies or any component of the test drug/reference drug.
- •17. Pregnancy or breastfeeding, as well as planning pregnancy throughout t
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