NCT01913730已完成2 期
A PHASE II MULTI-CENTRE, RANDOMIZED, OPEN LABEL STUDY OF PROLONGED THERAPY WITH SC BORTEZOMIB TWICE MONTHLY ASSOCIATED WITH DEXAMETHASONE, IN RELAPSED AND REFRACTORY MULTIPLE MYELOMA PATIENTS AFTER SALVAGE WITH BORTEZOMIB-BASED THERAPY.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Time to Progression
研究概览
简要总结
This is a multicenter, randomized, open label study designed to evaluate the efficacy and safety of prolonged treatment with bortezomib twice monthly and dexamethasone after a salvage treatment containing bortezomib for relapsed or refractory multiple myeloma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is of a legally consenting age as defined by local regulations.
- •Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements.
- •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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- •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.
- •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.
- •Patient was previously diagnosed with multiple myeloma based on standard criteria.
- •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.
- •Patient had previously received at least 4 cycles of a salvage treatment containing bortezomib, before enrolment, without evidence of progressive disease.
- •Patient must be enrolled and start therapy within 45 days from the completion of the last salvage cycle containing Bortezomib.
- •Before the salvage treatment with bortezomib-based regimens, patient must have measurable disease
排除标准
- •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.
- •Pregnant or lactating females
- •Known positive for HIV or active infectious hepatitis type A, B or C
- •Peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 4.0
- •Infiltrative pulmonary disease.
研究组 & 干预措施
Bortezomib Dexamethasone (Biochemical relapse)
Experimental
Patients randomized in this group will be observed. At the occurrence of biochemical relapse, 4 VD cycles will be administered: Bortezomib (SC) and Dexamethasone (PO) weekly.
干预措施: Bortezomib (Drug)
Bortezomib Dexamethasone (Biochemical relapse)
Experimental
Patients randomized in this group will be observed. At the occurrence of biochemical relapse, 4 VD cycles will be administered: Bortezomib (SC) and Dexamethasone (PO) weekly.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Time to Progression
时间窗: 5 years
次要结局
- Response(5 years)
- Survival(5 years)
研究者
研究点 (1)
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