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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Ibandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks.
Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks.
Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to 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.
Time frame: Baseline, Week 44
Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to 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.
Time frame: Baseline, Week 92
Percentage of Participants With Skeletal-Related Events (SREs)
SREs were defined according to the Bondronat Summary of Product Characteristics (SmPC) to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The percentage of participants with at least 1 SRE during the study was reported.
Time frame: From Baseline to end of study (up to Week 96)
Time to First SRE
SREs were defined according to the Bondronat SmPC to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. Time to first SRE was defined as the time from first dose of study drug to the time of SRE during the study. The median time to first SRE was estimated by Kaplan-Meier analysis and expressed in days.
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Unnamed facility
Ansbach, Germany
Unnamed facility
Aschaffenburg, Germany
Unnamed facility
Augsburg, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Bremen, Germany
Unnamed facility
Cologne, Germany
Unnamed facility
Cologne, Germany
Unnamed facility
Duisburg, Germany
...and 46 more locations
Time frame: From Baseline to end of study (up to Week 96)
Number of SREs for Each Participant
SREs were defined according to the Bondronat SmPC to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The number of SREs was averaged across all participants, including those participants who did not experience SREs during the study.
Time frame: From Baseline to end of study (up to Week 96)
Percentage of Participants With Osteonecrosis of Jaw
The percentage of participants with at least 1 event of osteonecrosis of jaw during the study was reported.
Time frame: From Baseline to end of study (up to Week 96)
Number of Events of Osteonecrosis of Jaw for Each Participant
The number of events of osteonecrosis of jaw was averaged across all participants, including those participants who did not experience the event during the study.
Time frame: From Baseline to end of study (up to Week 96)
Percentage of Participants With Zoledronate Dose Reduction
The percentage of participants with at least 1 zoledronate dose reduction during the study was reported.
Time frame: From Baseline to end of study (up to Week 96)
Number of Zoledronate Dose Reductions for Each Participant
The number of zoledronate dose reductions was averaged across all participants, including those participants who did not have any dose reductions during the study.
Time frame: From Baseline to end of study (up to Week 96)
Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)
The percent change in B-NAG was calculated as \[Week 44 or 92 B-NAG minus Baseline B-NAG\] divided by Baseline B-NAG, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.
Time frame: Baseline and Weeks 44, 92
Percent Change From Baseline in Alpha (A) 1-Microglobulin
The percent change in A1-microglobulin was calculated as \[Week 44 or 92 A1-microglobulin minus Baseline A1-microglobulin\] divided by Baseline A1-microglobulin, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.
Time frame: Baseline and Weeks 44, 92
Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)
The percent change in GGT was calculated as \[Week 44 or 92 GGT minus Baseline GGT\] divided by Baseline GGT, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.
Time frame: Baseline and Weeks 44, 92
Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline
Elevation in SCr was defined as an increase greater than (\>) 0.5 milligrams per deciliter (mg/dL) for participants with Baseline SCr less than (\<) 1.4 mg/dL, or an increase \>1.0 mg/dL for participants with Baseline SCr greater than or equal to (≥) 1.4 mg/dL. For the Week 44 analysis, the last available value on/before Week 44 was used. For the Week 92 analysis, the last available value on/before Week 92 was used. The percentage of participants with elevation of SCr at Weeks 44 and 92 was reported.
Time frame: Baseline and Weeks 44, 92
Percent Change From Baseline in CrCl
CrCl was calculated from blood samples using the Cockcroft-Gault formula, and was also measured by urinalysis. The percent change in CrCl was calculated as \[Week 44 or 92 CrCl minus Baseline CrCl\] divided by Baseline CrCl, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.
Time frame: Baseline and Weeks 44, 92