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Trial record 114 of 198 for:    osteonecrosis

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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Ibandronate Drug: Zoledronate Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COMPARE: Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Patients With Multiple Myeloma
Study Start Date : February 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009


Arm Intervention/treatment
Experimental: Ibandronate
Participants with multiple myeloma will be randomized to receive ibandronate every 4 weeks for a planned duration of 92 weeks.
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

Active Comparator: Zoledronate
Participants with multiple myeloma will be randomized to receive zoledronate every 4 weeks for a planned duration of 92 weeks.
Drug: Zoledronate
Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739594


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Sponsors and Collaborators
Hoffmann-La Roche
Roche Pharma AG
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02739594     History of Changes
Other Study ID Numbers: ML18508
2005-003264-38 ( EudraCT Number )
First Posted: April 15, 2016    Key Record Dates
Results First Posted: July 22, 2016
Last Update Posted: July 22, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Ibandronic acid
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs