EUCTR2008-000007-28-DE进行中（未招募）1 期
enalidomide (Revlimid®), Adriamycin and Dexamethasone (RAD) as an Induction Therapy in Newly Diagnosed Multiple Myeloma Followed by a Risk-Defined Transplant Strategy and Lenalidomide Maintenance – A Multicenter Phase II Trial by Deutsche Studiengruppe Multiples Myelom
niversitaetsklinikum Wuerzburg0 个研究点目标入组 190 人开始时间: 2009年2月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 190
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
- •Main Inclusion Criteria (for RAD)
- •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.Able to adhere to the study visit schedule and other protocol requirements.
- •4.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 general osteoporosis or
- •- symptomatic hyperviscosity or
- •- recurrent bacterial infection (= 2 per year)
- •and measurable disease parameters
- •- IgG myeloma: Serum monoclonal paraprotein (M-protein) level = 1.0 g/dL or urine M-protein level = 200 mg/24 hours or IgA myeloma: Serum M-protein level = 0.5 g/dL or urine M-protein level = 200 mg/24 hours or IgD myeloma: Serum M-protein level = 0.05 g/dL or urine M-protein level = 200 mg/24 hours or Light chain myeloma: Serum M-protein level = 1.0 g/dL or urine M protein level = 200 mg/24 hours
- •5. A maximum of two cycles of one prior anti-myeloma regimen excluding thalidomide (i.e., dexamethasone; AD; ID; VAD; VID; melphalan/prednisone).
- •6. Cardiac ejection fraction (LVEF) of at least 55% assessed by 2-d echocardiography within 28 days prior to first cycle of RAD
- •7. DLCO of at least 60% of age matched controls or if DLCO cannot be measured pO2 [art.] = 70 mm Hg as a substitute for DCLO
- •8. ECOG performance status of <= 2 at study entry (see Appendix III).
- •9. Laboratory test results within these ranges:
- •- Absolute neutrophil count = 1.5 x 10E9/L
- •- Platelet count = 75 x 10E9/L
- •- Calculated creatinine clearance = 50 mL/minute.
- •- Total bilirubin = 1.5 mg/dL
- •- AST (SGOT) and ALT (SGPT) <= 2 x ULN
- •10.Disease free of prior malignancies for = 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix or breast
- •11.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 six months following diagnosis/enrolment. If impaired renal function is present, measurement of anti-factor-Xa-activity must be performed.
- •12.Two cycles of any standard anti-myeloma chemotherapy, plasmapheresis for hyperviscosity and radiotherapy for symptomatic fractures or surgery for compression syndromes are allowed. Patients must not have progression on conventional cytotoxic pre-treatment.
- •13.Patients willing and able to undergo tandem-autologous and (if allocated to the autologous-allogeneic arm) allogeneic transplantation
- •14.Bone marrow sample available for assessment of cytogenetic factors by FISH analysis (centralized diagnostic laboratory)
- •Inclusion Criterias for a) autologous/allogeneic stem cell transplantation, b) Lenalidomide maintenance phase, c) Contraception see protocol.
- •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. Progressive disease (PD) to any initial treatment, such as dexamethasone, dex-anthracycline combinations or melphalan/prednisone. Those patients are considered to have refractory disease, the treatment of which is not an endpoint of this protocol.
- •3. Pregnant or lactating females.
- •4. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •5. Use of any other experimental drug or experimental therapy within 28 days of baseline and for duration of the entire study.
- •6. Neuropathy of <= grade 2 severity
- •7. Known hypersensitivity to thalidomide.
- •8. The development of erythema nodosum; if characterized by a desquamating rash while taking thalidomide or similar drugs.
- •9. Any prior use of lenalidomide.
- •10. Positive for HIV or infectious hepatitis, type A, B or C or treponema pallidum after serologic testing
- •11. History of myocardial infarction (both STEMI and non-STEMI).
- •12. Concomitant myocarditis or perimyocarditis.
- •Exclusion criterion for second cycle of high-dose melphalan
- •13.The second cycle of high-dose melphalan must only be initiated if in addition to the planned graft a back up” of at least 2 x 106 CD34+ cells of the patient be present that may be used in case of graft failure.
- •Exclusion criteria for allogeneic stem cell transplantation
- •14. Serum creatinine despite induction therapy = 2.0 mg/dL
研究者
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