EUCTR2013-005485-19-DE进行中（未招募）1 期
Bendamustine, Prednisone and Velcade® for first-line treatment of patients with symptomatic multiple myeloma not eligible for high-dose chemotherapy followed by autologous stem cell transplantation (BPV). - BPV
Ruprecht-Karls-University Heidelberg, Med Faculty represented by University Clinic HD and its Comm. Director0 个研究点目标入组 46 人开始时间: 2014年7月18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
- 46
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
入选标准
- •1.Newly diagnosed multiple myeloma requiring systemic treatment (according to CRAB criteria as specified in the appendix) with following characteristics: Subject is not a candidate for high-dose chemotherapy and stem cell transplantation due to age, presence of comorbidities likely to have a negative impact on tolerability of HDT-SCT, or subject preference
- •2.Measurable disease, defined as any quantifiable monoclonal protein value, defined by at
- •least one of the following three measurements (International Working Group , 2003 and Durie et al, 2006) (see appendix II)
- •a.Serum M-protein = 10g/l
- •b.Urine light-chain (M-protein) of = 200 mg/24 hours
- •c.Serum FLC assay: involved FLC level = 10 mg/dl provided sFLC ratio is abnormal
- •3.Age =18 years
- •4.WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by co-morbid conditions) 5.For women of childbearing potential: negative pregnancy test at inclusion
- •6.All men and women of childbearing potential must be willing and capable to use highly effective contraception during the complete therapy. [CPMP/ICH/286/95 mod: Highly effective
- •methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e.,less than 1% per year) when used consistently and correctly. Examples of Highly effective and additional
- •methods:- Intrauterine device (IUD), Hormonal (birth control pills, injections, implants), Tubal ligation,Partner’s vasectomy. Additional effective methods: Male condom, Diaphragm, Cervical Cap]
- •7. All patients must agree to abstain from donating blood while on study
- •8.Ability to understand character and individual consequences of the clinical trial
- •9.Written informed consent (must be available before enrolment in the trial)
- •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 46
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 41
排除标准
- •Subjects presenting any of the following criteria will not be included in the trial:
- •1.Patient has known hypersensitivity to bortezomib, bendamustine, prednisone or to any of the constituent compounds (incl. boron and mannitol).
- •2.Systemic AL amyloidosis (except for patients with AL amyloidosis of the skin or the bone marrow)
- •3.Previous chemotherapy or radiotherapy during the past 5 years except patient’s local radiotherapy in case of local myeloma progression. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy within 3 weeks prior to study entry.)
- •4.Plasma cell leukaemia which requires the presence of 20% of plasma cell in peripheral blood leukocytes and at least 2/nl.
- •5.Severe cardiac dysfunction (NYHA classification III-IV)
- •6.Significant hepatic dysfunction (serum bilirubin = 2 mg/dl or ASAT and/or ALAT = 2.5 times normal level), unless related to myeloma
- •7.Patients known to be HIV-positive
- •8.Patients with active, uncontrolled infections
- •9.Patients with peripheral neuropathy or neuropathic pain, CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0)
- •10.Second malignancy within the past 5 years except:
- •a.Adequately treated basal cell or squamous cell skin cancer,
- •b.Carcinoma in situ of the cervix, or
- •c.Prostate cancer < Gleason score 6 with undetectable prostate-specific antigen (PSA) over 12 months, or
- •d.Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins), or
- •e.Similar condition with an expectation of > 95 % 5-year disease free survival
- •11.Patients with acute diffuse infiltrative pulmonary and pericardial disease
- •12.Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia
- •13.Platelet count < 50 x 109/l (transfusion support within 14 days before the test is not allowed), unless related to myeloma
- •14.Hemoglobin < 7.5g/dl, unless related to myeloma
- •15.Absolute neutrophil count (ANC) < 0.75 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed), unless related to myeloma
- •16.Pregnancy and lactation
- •17.Participation in other clinical trials within one month prior to enrolment except patients for supportive care studies and vaccination studies. (Note: This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months).
研究者
相似试验
已完成
2 期
Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple MyelomaMultiple MyelomaNCT02237261University Hospital Heidelberg46
进行中（未招募）
1 期
Treatment with Lenalidomide, Bendamustine and Prednisone (RBP) in Patients with Relapsed or Refractory Multiple Myeloma after Autologous Stem Cell Transplantation or Conventional Chemotherapy OSHO #077 - OSHO #077Relapsed or refractory Multiple MyelomaMedDRA version: 18.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2008-001885-96-DEniversity of Leipzig50
进行中（未招募）
不适用
Bendamustine, Bortezomib and Dexamethasone (BVD) in the treatment of relapsed or refractory Multiple Myeloma - BVD-CLEM 01-10Relapsed or refractory multiple myelomaMedDRA version: 9.1Level: LLTClassification code 10051381EUCTR2010-020072-33-ITAZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
进行中（未招募）
1 期
Phase I/II clinical trial with Bendamustine and Temsirolimus in patients with relapsed or refractory mantle cell lymphoma that are not eligible for high dose chemotherapy and stem cell transplantation. - Bendamustine and Temsirolimus in relapsed or refractory mantle cell lymphomaEUCTR2009-014844-13-DECharité Universitätsmedizin Berlin20
已完成
2 期
Bendamustine, Bortezomib (Velcade ®) and Prednisone (BVP) in Patients Newly Diagnosed Multiple MyelomaMultiple MyelomaNCT01376401PETHEMA Foundation60