EUCTR2009-016616-21-DE进行中（未招募）1 期
enalidomide, Adriamycin, Dexamethasone (RAD)Versus Lenalidomide, Bortezomib, Dexamethasone (VRD) for Induction in Newly Diagnosed Multiple Myeloma followed by Response-adapted Consolidation and Lenalidomide Maintenance - A Randomized Multicenter Phase III Trial by Deutsche Studiengruppe Multiples Myelom (DSMM XIV)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 470
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Understand and voluntarily sign an informed consent form.
- •2. Age =18 and = 65 years at the time of signing the informed consent form
- •3. Eligible for autologous and allogeneic stem cell Transplantation
- •4. Must not have been previously treated with any prior systemic therapy for the treatment of multiple
- •myeloma (dexamethasone at a cumulative dose of 320 mg; plasmapheresis/dialysis without concomitant chemotherapy, local irradiation of bone lesions; and surgical intervention is accepted
- •as pretreatment)
- •5. Newly diagnosed multiple myeloma with the diagnostic criteria as follows:
- •Monoclonal plasma cells in the bone marrow = 10% (histology) and/or biopsy-proven plasmacytoma
- •Monoclonal protein present in serum and/or urine on immunofixation
- •Myeloma-related organ dysfunction, at least one of
- •[C] Calcium elevation in the serum (> 11.5 mg/dL or upper limit of normal)
- •[R] Renal insufficiency (creatinine > 2 mg/dL )
- •[A] Anemia (Hb < 10 g/dL or 2 g/dL < normal)
- •[B] Bone lesions or eneral osteoporosis
- •symptomatic hyperviscosity or ecurrent acterial infection (= 2 per year) and measurable disease parameters as follows:
- •- Serum monoclonal paraprotein (M-component) level = 1 g/dL and/or urine Mprotein level = 200 mg/24 hours
- •- In case of IgA myeloma: Serum monoclonal paraprotein level = 0.5 g/dL and/or urine M-protein level = 200 g/24 hours.
- •- For patients with no detectable M-component:
- •Serum FLC assay: Involved FLC level > 10 mg/dl (> 100 mg/l) provided serum FLC ratio is abnormal.
- •6. Cardiac ejection fraction (LVEF) of at least 50% assessed by 2-d echocardiography within 28 days
- •prior to first cycle of RAD or VRD
- •7. Corrected DLCO (single breath) of at least 50% of age-matched controls; alternatively pO2 [art.] of
- •at least 70 mmHg
- •8. Karnofsky performance status of greater or equal to 50% (see Appendix III)
- •9. Laboratory test results within these ranges:
- •Absolute neutrophil count = 1.0 x 109/L
- •Platelet count = 75 x 109/L
- •Hemoglobin > 8 g/dL
- •Calculated creatinine clearance (MDRD) = 30 mL/Minute
- •Total bilirubin < 1.5 x ULN
- •AST and ALT < 2.5 x ULN
- •Corrected serum calcium level < 3.5 mmol/l (< 4 mg/dl)
- •10. Pregnancy prevention plan for all females, females with childbearing (FCBP) potential, females not of childbearing potential, male subjects and all subjects. For Details please see chapter 5.3.2.1 (inclusion criteria) of protocol Version 9.0 (29.09.2017).
- •11. Bone marrow sample available for analysis of molecular cytogenetics (Lab Dr. Langer, Ulm).
- •12. Able to administer low molecular-weight heparin (either enoxaparin 40 mg once daily or dalteparin
- •5.000 IU once daily) as a prophylactic anticoagulation therapy for the first three months following
- •diagnosis/enrolment (applicable for subjects randomized to RAD) and able to administer ASS 100
- •mg/d (applicable for subjects randomized to VRD). If impaired renal function is present,
- •measurement of anti-factor-Xa-activity must be performed.
- •13. Patients willing and able to undergo autologous and allogeneic transplantation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would
- •prevent the subject from signing the informed consent form
- •2. Pregnant or lactating females
- •3. Any condition, including the presence of laboratory abnormalities, which places the
- •subject at unacceptable risk
- •4. History of myocardial infarction; NYHA Class III or IV heart failure, uncontrolled
- •angina, severe uncontrolled ventricular arrhythmias; concomitant pericarditis or peri-
- •/myocarditis
- •5. Use of any other experimental drug or therapy within 28 days of baseline.
- •6. Greater or equal to Grade 2 peripheral neuropathy on clinical examination within 14
- •days before enrollment
- •7. Known intolerance of boron
- •8. Hypersensitivity to acyclovir or similar anti-viral drug
- •9. Prior malignancy
- •10. HIV positive, active hepatitis B, C or D viral infection, known CMV reactivation/active
- •infection, EBV reactivation/active infection or treponema pallidum infection
- •11. Uncontrolled diabetes mellitus
- •12. Non-secretory MM
- •13. Clinically relevant active infection or serious co-morbid medical conditions
- •14. Cardiac amyloidosis
研究者
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