NCT01087008已完成4 期
Assessment of the Antitumour Effect of Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse: Prospective Clinical Trial of the GEM/PETHEMA Group
PETHEMA Foundation16 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 16
- 主要终点
- Time to next need treatment
研究概览
简要总结
Assessment of the antitumour effect of zoledronic acid in patients with multiple myeloma and asymptomatic biochemical relapse
It´s proposed to investigate the use of Zoledronic acid as single therapy in patients with Multiple Myeloma in biochemical relapse. The following must be noted:
- Patients with no formal indication for chemotherapy treatment will be included, as patients with symptomatic myeloma who after responding show biochemical relapse are generally not treated. This allows for generating both a group of patients untreated, on no additional treatment and a treatment group on zoledronic acid.
- As these are relapsing symptomatic patients, their number is far higher than patients with quiescent Multiple Myeloma. This allows for expecting a good enrolment.
- There are few reliable data on symptom progression after biochemical relapse, though it is one of the new objectives occurring in almost all clinical trials on myeloma. In the VISTA study, it has been estimated that the median time to the new treatment is 5 months (combining progression-free time and time to the next treatment). This time is much shorter than the median quiescent myeloma progression-free survival, so a very long follow-up time will not be necessary in this patient group.
- The administration of this drug to these patients can help prevent skeleton-related complications in the future, the study of which will be a secondary objective of this study.
详细描述
Zometa is administrated every 4 weeks at dose of 4 mg. The limit of administrations is 12. The first infusion is in the visit 2 and the last is in visit 13
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Male or female patients aged ≥18 years.
- •Signed informed consent before performing any study procedure that is not the part of the regular medical care of the patients.
- •Diagnosis of MM, with biochemical relapse after initial response with no symptoms resulting from the disease (CRAB), defined as a re-positivation of a previous immunofixation (two samples) or increase above 25% of serum or urine protein M.
- •In the investigator's opinion, ability to meet all clinical trial requirements
排除标准
- •Treatment with bisphosphonates (oral route and/or endovenous route) within 3 months prior to inclusion.
- •Treatment with denosumab within three months prior to inclusion.
- •Criteria of symptomatic disease or organic damage related to disease, defined as:
- •Impaired renal function: serum creatinine >2 mg/dl or 173 mmol/l. Calcium increase: serum calcium ≥12 mg/dl within 28 days prior to inclusion.
- •Anaemia: haemoglobin < 10 g/dl or 2 g/dl below normal ranges.
- •Bone injury: new osteolytic lesions (from diagnosis) seen within 3 months prior to inclusion, current pathological fractures or increase of osteopenia (from diagnosis) in bone radiology series.
- •Others: amyloidosis with current organic damage, recurrent bacterial infections (more than 2 events in 12 months), symptomatic hyperviscosity, presence of plasmacytomas.
- •Patients with current and active dental disorders (dental, jaw infection, bone exposed in the mouth, jaw osteonecrosis).
- •Patients developing jaw osteonecrosis or other serious adverse events due to treatment with any bisphosphonate .
- •Significant liver disease:
- •Bilirubin > 3 g/dl.
- •ALT > 2.5 x the upper limit of normal
- •AST > 2.5 x the upper limit of normal
- •Patients who are currently in another clinical trial or receiving any investigational agent.
- •Pregnancy or nursing.
- •Parathyroid gland diseases.
- •Previous malignancy with a high risk of death or bone disease: breast cancer, prostate cancer or lung cancer, even if on complete response.
- •Active presence of neoplasms other than Multiple Myeloma
研究组 & 干预措施
Zoledronate acid
Experimental
干预措施: zoledronic acid (Drug)
No treatment control
Other
干预措施: No treatment control (Other)
结局指标
主要结局
Time to next need treatment
时间窗: 6 months
Time to the next treatment, considered as the time from the randomization date to the start of the next chemotherapy treatment for Multiple Mieloma or death for any cause
次要结局
- Time to symptom relapse(1 year)
- disease progression(2 years)
- antitumour effect of ZOL(1 year)
- prognostic factors(2 years)
- Overall survival(5 years)
研究者
研究点 (16)
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