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临床试验/EUCTR2013-000432-10-IT
EUCTR2013-000432-10-IT进行中（未招募）不适用

A PHASE II MULTI-CENTRE, RANDOMIZED, OPEN LABEL STUDY OF PROLONGED THERAPY WITH SUBCUTANEOUS BORTEZOMIB TWICE MONTHLY ASSOCIATED WITH DEXAMETHASONE, IN RELAPSED AND REFRACTORY MULTIPLE MYELOMA PATIENTS AFTER SALVAGE WITH BORTEZOMIB-BASED THERAPY.

DUTCH BELGIAN COOPERATIVE GROUP FOR HEMATOLOGY ONCOLOGY - HOVO0 个研究点目标入组 154 人开始时间: 2013年3月27日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
154
研究概览入排标准研究者记录与标识符相似试验

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. Patient is of a legally consenting age as defined by local regulations.
  • •2. Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements.
  • •3. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
  • •4. Female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method) (Highly Effective Methods: Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal ligation; partner’s vasectomy; Additional Effective Methods: Latex condom; Diaphragm; Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of therapy.
  • •5. Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of bortezomib therapy.
  • •6. Patient was previously diagnosed with multiple myeloma based on standard criteria.
  • •7. Patient is relapsed or refractory after one to three lines of treatment and the last one must be a bortezomib-containing regimen, without evidence of progressive disease.
  • •8. Patient had previously received at least 4 cycles of a salvage treatment containing bortezomib, before enrolment, without evidence of progressive disease.
  • •9. Patient must be enrolled and start therapy within 45 days from the completion of the last salvage cycle containing Bortezomib.
  • •10. Before the salvage treatment with bortezomib-based regimens, patient must have measurable disease, defined as follows:
  • •- Secretory myeloma: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours;
  • •- Non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan) or abnormal free light chain ratio
  • •11. Patient has a Karnofsky performance status =60%.
  • •12.Patient has not:
  • •- other malignancy within the past 3 years. Exceptions: basal cell or non metastatic squamous;
  • •cell carcinoma of the skin, cervical carcinoma in situ or FIGO Stage 1 carcinoma of the cervix.
  • •- used any investigational drugs within 30 days before randomization.
  • •- uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis which prevent the use of study drug.
  • •- uncontrolled diabetes which prevent the use of high-dose Dexamethasone.
  • •- peripheral neuropathy > grade 2 as per NCI-CTC version 4.0 which prevents the use of bortezomib.
  • •- history of allergic reaction attributable to compounds containing boron or mannitol.
  • •- concurrent medical condition or disease (e.g., active systemic infection, pulmonary disease) that is likely to in

排除标准

  • •1.Any serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from signing the informed consent form or placed the subjects at unacceptable risk.
  • •2.Pregnant or lactating females
  • •3.Known positive for HIV or active infectious hepatitis type A, B or C
  • •4.Peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 4.0
  • •5.Infiltrative pulmonary disease.

研究者

发起方
DUTCH BELGIAN COOPERATIVE GROUP FOR HEMATOLOGY ONCOLOGY - HOVO

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