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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Ibandronate
Drug: Zoledronate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ibandronate Participants with multiple myeloma received ibandronate via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
Zoledronate Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.

Participant Flow:   Overall Study
    Ibandronate   Zoledronate
STARTED   46   43 
Completed at Week 44   11   5 
Completed at Week 96   10   10 
COMPLETED   21 [1]   15 [1] 
NOT COMPLETED   25   28 
Undesired Event                3                4 
Violation of Eligibility Criteria                1                2 
Protocol Violation                5                6 
Death                4                2 
Renal Insufficiency                4                6 
Administrative Reasons                1                3 
Withdrawal by Subject                1                1 
Lost to Follow-up                0                1 
Elevated Serum Creatinine                0                1 
Not Specified                6                2 
[1] Includes all participants who reached the protocol-defined end of study (either Week 44 or 96).



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat (ITT) Population: All participants who were randomized and received at least one dose of study medication and for whom at least one measurement of creatinine clearance (CrCl) was obtained.

Reporting Groups
  Description
Ibandronate Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
Zoledronate Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
Total Total of all reporting groups

Baseline Measures
   Ibandronate   Zoledronate   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   40   81 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.3  (9.4)   69.1  (9.1)   67.2  (9.4) 
Gender 
[Units: Participants]
     
Female   15   14   29 
Male   26   26   52 


  Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92   [ Time Frame: Baseline, Week 92 ]

3.  Secondary:   Percentage of Participants With Skeletal-Related Events (SREs)   [ Time Frame: From Baseline to end of study (up to Week 96) ]

4.  Secondary:   Time to First SRE   [ Time Frame: From Baseline to end of study (up to Week 96) ]

5.  Secondary:   Number of SREs for Each Participant   [ Time Frame: From Baseline to end of study (up to Week 96) ]

6.  Secondary:   Percentage of Participants With Osteonecrosis of Jaw   [ Time Frame: From Baseline to end of study (up to Week 96) ]

7.  Secondary:   Number of Events of Osteonecrosis of Jaw for Each Participant   [ Time Frame: From Baseline to end of study (up to Week 96) ]

8.  Secondary:   Percentage of Participants With Zoledronate Dose Reduction   [ Time Frame: From Baseline to end of study (up to Week 96) ]

9.  Secondary:   Number of Zoledronate Dose Reductions for Each Participant   [ Time Frame: From Baseline to end of study (up to Week 96) ]

10.  Secondary:   Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)   [ Time Frame: Baseline and Weeks 44, 92 ]

11.  Secondary:   Percent Change From Baseline in Alpha (A) 1-Microglobulin   [ Time Frame: Baseline and Weeks 44, 92 ]

12.  Secondary:   Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)   [ Time Frame: Baseline and Weeks 44, 92 ]

13.  Secondary:   Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline   [ Time Frame: Baseline and Weeks 44, 92 ]

14.  Secondary:   Percent Change From Baseline in CrCl   [ Time Frame: Baseline and Weeks 44, 92 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The Study was terminated as a result of slow recruitment. At the time of the decision to halt recruitment, the treatment duration was shortened to 40 weeks (instead of 92 weeks) for those participants who had not yet reached Week 48.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02739594     History of Changes
Other Study ID Numbers: ML18508
2005-003264-38 ( EudraCT Number )
First Submitted: April 12, 2016
First Posted: April 15, 2016
Results First Submitted: June 9, 2016
Results First Posted: July 22, 2016
Last Update Posted: July 22, 2016