EUCTR2009-016871-32-BE进行中（未招募）1 期
A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age (IFM/DFCI 2009) - IFM/DFCI 2009
CHU de TOULOUSE0 个研究点目标入组 700 人开始时间: 2011年2月21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
- 700
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
- •All laboratory assessments should be performed within 21 days of
- •initiation of protocol therapy:
- •Participants must have a diagnosis of MM, according to International
- •Myeloma Foundation 2003 Diagnostic Criteria. According to these
- •criteria, all three of the following must be met with screening tests
- •performed within 21 days of initiation of protocol therapy:
- •? Monoclonal plasma cells in the bone marrow > 10% (or proven
- •plasmocytic infiltration in bone marrow biopsy)and/or presence of a
- •biopsy-proven plasmacytoma
- •? Monoclonal protein (M-protein) present in the serum and/or urine.
- •? Myeloma-related organ dysfunction (1 or more) of the following. A
- •variety of other types of end-organ dysfunctions can occasionally occur
- •and lead to a need for therapy:
- •[C] Calcium elevation in the blood, defined as serum calcium > 10.5
- •mg/dl or upper limit of normal
- •[A] Anemia, defined as hemoglobin <10 g/dl or 2 g < normal
- •[B] Lytic bone lesions or osteoporosis. If a solitary (biopsy-proven)
- •plasmacytoma or osteoporosis alone (without fractures) are the sole
- •defining criteria, then > 30% plasma cells are required in the bone
- •marrow or proven plasmocytic infiltration in bone marrow biopsy..
- •Note: These criteria identify Stage IB and Stages II and III A/B
- •myeloma by Durie-Salmon stage. Stage IA becomes smoldering or
- •indolent myeloma.
- •Participants must have documented symptomatic myeloma with
- •organ damage related to myeloma as defined above with laboratory
- •assessments performed within 21 days of initiation of protocol therapy.
- •Participants must have myeloma that is measurable by either serum
- •or urine evaluation of the monoclonal component or by assay of serum
- •free light chains. Measurable disease is defined as one or more of the
- •following: serum M-protein = 1 g/dl, urine M-protein = 200 mg/24 h,
- •and/or serum FLC assay: involved FLC level = 10 mg/dl with abnormal
- •serum FLC ratio.
- •Age between 18 and 65 years at the time of signing the informed
- •consent form.
- •ECOG performance status =2 (Karnofsky =60%, see Appendix IV).
- •Negative HIV blood test within 21 days of initiation of protocol
- •therapy. HIV-positive individuals on combination antiretroviral therapy
- •are ineligible because of the potential for pharmacokinetic (PK)
- •interactions with lenalidomide, bortezomib and/or dexamethasone. In
- •addition, these individuals are at increased risk of lethal infections when
- •treated with marrow-suppressive therapy.
- •o Criteria for women of non-childbearing potential
- •A female subject or a female partner of a male subject is considered to
- •have childbearing potential unless she meets at least one of the
- •following criteria:
- •Age = 50 years and naturally amenorrhoeic for = 1 year*
排除标准
- •All laboratory assessments should be performed within 21 days of initiation of protocol therapy:
- •Participant treated with any prior systemic therapy. Treatment by localized radiotherapy is not an exclusion
- •criterion if an interval of at least two weeks between the end of radiotherapy and initiation of protocol therapy is
- •observed. Similarly, the dose of corticosteroids received by the participant as part of any initial therapy should
- •not exceed the equivalent of 160 mg of dexamethasone over a two-week period before initiation of protocol
- •therapy (see Appendix V for equivalence table).
- •Primary amyloidosis (AL) or myeloma complicated by amylosis.
- •Participants receiving any other investigational agents.
- •Participants with known brain metastases should be excluded from this clinical trial because of their poor
- •prognosis and because they often develop progressive neurologic dysfunction that would confound the
- •evaluation of neurologic and other adverse events.
- •Poor tolerability or known allergy to any of the study drugs or compounds of similar chemical or biologic
- •composition to lenalidomide, bortezomib and/or dexamethasone.
- •Participants with platelet level <50,000/mm3. Transfusion within 7 days of screening is not allowed to meet
- •platelet eligibility criteria
- •Participants with an absolute neutrophil count (ANC) <1000/uL. Growth factor within 7 days of screening is
- •not allowed to meet ANC eligibility criteria.
- •Participants with hemoglobin level < 8.0 g/dL. Transfusion may be used to meet hemoglobin eligibility criteria.
- •Hepatic impairment, defined as bilirubin > 1.5 ? Institutionnal ULN Total Bilirubin (Patients with benign
- •hyperbilirubinemia (e.g., Gilbert’s syndrome) are eligible ) or AST (SGOT), or ALT (SGPT), or alkaline
- •phosphatase = 2x ULN
- •Renal insufficiency, defined as serum creatinine > 170 µmol and/or creatinine clearance < 50 mL/min (either
- •actual or calculated values may be used). The Cockgroft-Gault formula should be used for calculating creatinine
- •clearance values:
- •(140-age) x Body mass (kg) x 0.85 (female) or 1.0 (male)
- •serum creat (mg/dL) x 72
- •Respiratory compromise, defined as ventilation tests with DLCO < 50%
- •Participant with clinical signs of heart or coronary failure, or evidence of left ventricular ejection fraction
- •(LVEF) < 40%. Participant with myocardial infarction within 6 months prior to enrollment or have New York
- •Heart Association (NYHA Appendix VII) Class III or IV heart failure, uncontrolled angina, severe uncontrolled
- •ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conductive system
- •abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator
- •as not medically relevant
- •Intercurrent illness including, but not limited to ongoing or active severe infection, known (active or not)
- •infection with hepatitis B or C virus, poor
研究者
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