COMPARE: Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Patients With Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 89
- 主要终点
- Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44
研究概览
简要总结
This multicenter, open-label trial will randomize participants with multiple myeloma to a regimen of ibandronate or zoledronate in order to compare the incidence of nephrotoxicity, measured as creatinine clearance (CrCl) reduction greater than (>) 30 percent (%) or an absolute value of 30 milliliters per minute (mL/min) or lower.
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
- •Confirmed multiple myeloma, Stage II-III as per Salmon and Durie (1975)
- •Indication for biphosphonate therapy
排除标准
- •Previous therapy with ibandronate or zoledronate within the past 12 months
- •Renal insufficiency with serum creatinine >3.0 mg/dL or >265 micromoles per liter (µmol/L) or CrCl <30 mL/min
- •Hypersensitivity to ibandronate, zoledronate, or other biphosphonates
- •Presence of secondary malignomas, apart from basaliomas and cervical carcinoma in situ
- •Severe accompanying illness with organ impairment
- •Osteonecrosis of the jaw at the start of the study
- •Life expectancy ≤12 months
研究组 & 干预措施
Ibandronate
Participants with multiple myeloma will be randomized to receive ibandronate every 4 weeks for a planned duration of 92 weeks.
干预措施: Ibandronate (Drug)
Zoledronate
Participants with multiple myeloma will be randomized to receive zoledronate every 4 weeks for a planned duration of 92 weeks.
干预措施: Zoledronate (Drug)
结局指标
主要结局
Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44
时间窗: Baseline, Week 44
CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30 percent (%) from Baseline or an absolute value less than or equal to (≤) 30 milliliters per minute (mL/min) at Week 44. The last available value on/before Week 44 was used in the calculation. The percentage of participants with deterioration in renal function at Week 44 was reported.
Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92
时间窗: Baseline, Week 92
CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30% from Baseline or an absolute value ≤30 mL/min at Week 92. The last available value on/before Week 92 was used in the calculation. The percentage of participants with deterioration in renal function at Week 92 was reported.
次要结局
- Number of SREs for Each Participant(From Baseline to end of study (up to Week 96))
- Percentage of Participants With Osteonecrosis of Jaw(From Baseline to end of study (up to Week 96))
- Percentage of Participants With Skeletal-Related Events (SREs)(From Baseline to end of study (up to Week 96))
- Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)(Baseline and Weeks 44, 92)
- Percentage of Participants With Zoledronate Dose Reduction(From Baseline to end of study (up to Week 96))
- Number of Zoledronate Dose Reductions for Each Participant(From Baseline to end of study (up to Week 96))
- Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline(Baseline and Weeks 44, 92)
- Time to First SRE(From Baseline to end of study (up to Week 96))
- Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)(Baseline and Weeks 44, 92)
- Percent Change From Baseline in CrCl(Baseline and Weeks 44, 92)
- Number of Events of Osteonecrosis of Jaw for Each Participant(From Baseline to end of study (up to Week 96))
- Percent Change From Baseline in Alpha (A) 1-Microglobulin(Baseline and Weeks 44, 92)