KCT0005839尚未招募未知
Phase 2 study of Daratumumab in combination with bortezomib and dexamethasone in newly diagnosed multiple myeloma
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 63
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 65(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Newly diagnosed Multiple myeloma, diagnosed according to standard criteria, in subjects who are not eligible for high dose Melphalan and stem cell transplant.
- •2. Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)
- •a. Serum M-protein = 0.5g/dL, or
- •b. In subjects without detectable serum M-protein, Urine M-protein = 200mg/24 hour, or serum free light chai (sFLC) > 100mg/L (involved light chain) and an abnormal kappa/Lambda ratio
- •3. Must have received no prior treatment. Short duration of steroids are acceptable.
- •4. Males and females = 18 years of age or > country’s legal age for adult consent
- •5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- •6. Patients must meet the following clinical laboratory criteria with 21 days of starting treatment:
- •a. Absolute neutrophil count (ANC) = 1,000/mm3 and platelet = 50,000/mm3 (= 30,000/mm3 if myeloma involvement in the bone marrow is >50%)
- •b. Total bilirubin = 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x ULN.
- •c. Calculated creatinine clearance = 30mL/min.
- •7. Written informed consent in accordance with federal, local and institutional guidelines
排除标准
- •1. Female patients who are lactating or pregnant or those with plans for pregnancy within 3 months of last daratumumab infusion
- •2. Multiple Myeloma of IgM subtype
- •3. Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 7 days prior to informed consent obtained
- •4. POEMS syndrome
- •5. Plasma cell leukemia or circulating plasma cells = 2 x 109/L
- •6. Waldenstrom’s Macroglobulinaemia
- •7. Existing peripheral neuropathy of grade 2 or higher or presence of neuropathic pain
- •8. Patients with known amyloidosis
- •9. Any Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to starting Dara-VD treatment
- •10. Focal radiation therapy within 7 days prior to start of Dara-VD. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of Dara-VD.
- •11. Immunotherapy (excluding steroids) 21 days prior to start of Dara-VD
- •12. Major surgery (excluding kyphoplasty) within 28 days prior to start of Dara-VD
- •13. Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained
- •14. Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed)
- •15. Patients with known cirrhosis
- •16. Patients with creatinine clearance <30ml/min
- •17. Second malignancy within the past 3 years except:
- •a. Adequately treated basal cell or squamous cell skin cancer
- •b. Carcinoma in situ of the cervix
- •c. Breast carcinoma in situ with full surgical resection
- •18. Patients with myelodysplastic syndrome
- •19. Patients with steroid/bortezomib hypersensitivity
- •20. Patients previously treated with daratumumab or other anti-CD38 antibodies.
- •21. Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to starting Dara-VD treatment
- •22. Contraindication to any of the required concomitant drugs or supportive treatments
- •23. Any clinically significant medical disease or psychiatric condition that, in the investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent.
- •24. Known COPD with FEV1 < 50% of normal.
- •25. Moderate or severe persistent asthma within the last 2 years, or uncontrolled asthma of any classification
- •26. Uncontrolled diabetes mellitus
- •27. history of allergic reaction to bortezomib or its ingredients (mannitol, boron)
- •28. history of allergic reaction to dexamethasone or its ingredients
- •29. patients with diffuse interstitial lung disease and/or pericardial disease
- •30. live vaccination within 1 year
- •31. patients with genetic enzyme deficiency disorders including galactose intolerance, lapp lactase deficiency and glucose-galatcose malabsorption
- •32. active infection with HSV, zoster or varicella
- •33. active infection without treatable antibiotics or current systemic fungal infection
- •34. history of allergy or resistance to monoclonal antibody or humanized protein products or mammal-based products
研究者
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