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Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma (COMPARE)

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ClinicalTrials.gov Identifier: NCT02739594
Recruitment Status : Terminated (Slow recruitment)
First Posted : April 15, 2016
Results First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Hoffmann-La Roche

April 12, 2016
April 15, 2016
June 9, 2016
July 22, 2016
July 22, 2016
February 2006
April 2009   (Final data collection date for primary outcome measure)
  • Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44 [ Time Frame: 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 [ Time Frame: 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.
  • Percentage of Participants with Deterioration in Renal Function According to Reduction in CrCl from Baseline to Week 44 [ Time Frame: Baseline to Week 44 ]
  • Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92 [ Time Frame: Baseline to Week 92 ]
Complete list of historical versions of study NCT02739594 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Skeletal-Related Events (SREs) [ Time Frame: From Baseline to end of study (up to Week 96) ]
    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 to First SRE [ Time Frame: From Baseline to end of study (up to Week 96) ]
    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.
  • Number of SREs for Each Participant [ Time Frame: From Baseline to end of study (up to Week 96) ]
    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.
  • Percentage of Participants With Osteonecrosis of Jaw [ Time Frame: From Baseline to end of study (up to Week 96) ]
    The percentage of participants with at least 1 event of osteonecrosis of jaw during the study was reported.
  • Number of Events of Osteonecrosis of Jaw for Each Participant [ Time Frame: From Baseline to end of study (up to Week 96) ]
    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.
  • Percentage of Participants With Zoledronate Dose Reduction [ Time Frame: From Baseline to end of study (up to Week 96) ]
    The percentage of participants with at least 1 zoledronate dose reduction during the study was reported.
  • Number of Zoledronate Dose Reductions for Each Participant [ Time Frame: From Baseline to end of study (up to Week 96) ]
    The number of zoledronate dose reductions was averaged across all participants, including those participants who did not have any dose reductions during the study.
  • Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG) [ Time Frame: Baseline and Weeks 44, 92 ]
    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.
  • Percent Change From Baseline in Alpha (A) 1-Microglobulin [ Time Frame: Baseline and Weeks 44, 92 ]
    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.
  • Percent Change From Baseline in Gamma-Glutamyltransferase (GGT) [ Time Frame: Baseline and Weeks 44, 92 ]
    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.
  • Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline [ Time Frame: Baseline and Weeks 44, 92 ]
    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.
  • Percent Change From Baseline in CrCl [ Time Frame: Baseline and Weeks 44, 92 ]
    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 to First Skeletal-Related Adverse Event (SRE) According to Medical Dictionary for Regulatory Activities (MedDRA) Classification [ Time Frame: Screening; pre-dose (0 hours) and on Days 2, 3, 4 of every other treatment (every 8 weeks); at Week 68; and end of study (up to 92 weeks overall) ]
  • Number of SREs According to MedDRA Classification [ Time Frame: Screening; pre-dose (0 hours) and on Days 2, 3, 4 of every other treatment (every 8 weeks); at Week 68; and end of study (up to 92 weeks overall) ]
  • Number of Participants with SREs According to MedDRA Classification [ Time Frame: Screening; pre-dose (0 hours) and on Days 2, 3, 4 of every other treatment (every 8 weeks); at Week 68; and end of study (up to 92 weeks overall) ]
  • Number of Participants with Osteonecrosis of Jaw [ Time Frame: Screening; pre-dose (0 hours) and on Days 2, 3, 4 of every other treatment (every 8 weeks); at Week 68; and end of study (up to 92 weeks overall) ]
  • Percentage of Participants with Any Zoledronate Dose Reduction [ Time Frame: Screening, then every 4 weeks during treatment (up to 92 weeks overall) ]
  • Change from Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG) [ Time Frame: Baseline to Weeks 44, 92 ]
  • Change from Baseline in Alpha-1-Microglobulin [ Time Frame: Baseline to Weeks 44, 92 ]
  • Change from Baseline in Gamma-Glutamyltransferase (GGT) [ Time Frame: Baseline to Weeks 44, 92 ]
  • Number of Participants with Serum Creatinine Increase >0.5 Milligrams per Deciliter (mg/dL) from Baseline [ Time Frame: Baseline to Weeks 44, 92 ]
  • Number of Participants with Serum Creatinine Increase >1.0 mg/dL from Baseline [ Time Frame: Baseline to Weeks 44, 92 ]
  • Change from Baseline in CrCl [ Time Frame: Baseline to Weeks 44, 92 ]
Not Provided
Not Provided
 
Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma
COMPARE: Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Patients With Multiple Myeloma
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: Ibandronate
    Ibandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks.
    Other Name: Bondronat
  • Drug: Zoledronate
    Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks.
  • Experimental: Ibandronate
    Participants with multiple myeloma will be randomized to receive ibandronate every 4 weeks for a planned duration of 92 weeks.
    Intervention: Drug: Ibandronate
  • Active Comparator: Zoledronate
    Participants with multiple myeloma will be randomized to receive zoledronate every 4 weeks for a planned duration of 92 weeks.
    Intervention: Drug: Zoledronate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
89
Same as current
April 2009
April 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed multiple myeloma, Stage II-III as per Salmon and Durie (1975)
  • Indication for biphosphonate therapy

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT02739594
ML18508
2005-003264-38 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Roche Pharma AG
Study Chair: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP