Multiple MyelomaPhase 3COMPARENCT02739594
Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma
A Phase 3 study testing Ibandronate and Zoledronate in people with Multiple Myeloma, run by Hoffmann-La Roche at 56 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Ibandronate and Zoledronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 56 sitesGermany
- Study dates
- Feb 2006to Apr 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed multiple myeloma, Stage II-III as per Salmon and Durie (1975)
- Indication for biphosphonate therapy
Who cannot join
- 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
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
Germany56 sites
Study site
Ansbach, 91522
Study site
Aschaffenburg, 63739
Study site
Augsburg, 86150
Study site
Berlin, 10437
Study site
Berlin, 10707
Study site
Berlin, 12627
Study site
Bremen, 28239
Study site
Cologne, 50677
Study site
Cologne, 50924
Study site
Duisburg, 47051
Study site
Duisburg, 47166
Study site
Erlangen, 91054
Study site
Essen, 45136
Study site
Esslingen am Neckar, 73730
Study site
Frankfurt am Main, 60389
Study site
Frankfurt am Main, 65929
Study site
Göttingen, 37075
Study site
Greifswald, 17475
Study site
Güstrow, 18273
Study site
Gütersloh, 33332
Study site
Halle, 06110
Study site
Hamburg, 22081
Study site
Hamburg, 22457
Study site
Hamm, 59063
Study site
Hanover, 30171
Study site
Hanover, 30625
Study site
Herne, 44625
Study site
Hof, 95028
Study site
Jena, 07743
Study site
Karlsruhe, 76137
Study site
Kassel, 34117
Study site
Kassel, 34125
Study site
Koblenz, 56068
Study site
Krefeld, 47798
Study site
Leer, 26789
Study site
Leipzig, 04289
Study site
Lübeck, 23562
Study site
Ludwigshafen, 67063
Study site
Magedburg, 39104
Study site
Minden, 32427
Study site
Moers, 47441
Study site
Mülheim, 45468
Study site
München, 80336
Study site
Münster, 48149
Study site
Neumünster, 24534
Study site
Offenbach, 63069
Study site
Offenburg, 77652
Study site
Oldenburg, 26121
Study site
Oldenburg, 26133
Study site
Stuttgart, 70174
Study site
Stuttgart, 70199
Study site
Tübingen, 72076
Study site
Weiden, 92637
Study site
Wiesbaden, 65191
Study site
Würzburg, 97080
Study site
Zwickau, 08058
About this study
Official title: 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.
- Conditions
- Multiple Myeloma
- Being tested
- Ibandronate, Zoledronate
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbandronateDrug
Also called Bondronat
Ibandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks.
ZoledronateDrug
Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ibandronate | Experimental | Participants with multiple myeloma will be randomized to receive ibandronate every 4 weeks for a planned duration of 92 weeks. Receives: Drug: Ibandronate |
| Zoledronate | Active comparator | Participants with multiple myeloma will be randomized to receive zoledronate every 4 weeks for a planned duration of 92 weeks. Receives: Drug: Zoledronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 92
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Weeks 44, 92
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startFeb 2006
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739594
- Sponsor's protocol ID
- ML18508
- Other IDs
- 2005-003264-38, 2005
- Acronym
- COMPARE
- Status last verified
- Jun 2016
- First submitted
- 12 Apr 2016
- Last updated
- 22 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARE: Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02739594
- Acronym / sponsor ID
- COMPARE / ML18508
- Conditions
- Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG
- Study start
- Feb 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Posted 22 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibandronate | Experimental | Drug: IbandronateParticipants with multiple myeloma will be randomized to receive ibandronate every 4 weeks for a planned duration of 92 weeks. |
| Zoledronate | Active comparator | Drug: ZoledronateParticipants with multiple myeloma will be randomized to receive zoledronate every 4 weeks for a planned duration of 92 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed multiple myeloma, Stage II-III as per Salmon and Durie (1975)
- Indication for biphosphonate therapy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbandronateAlso: BondronatIbandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks. | Drug | Ibandronate |
| ZoledronateZoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks. | Drug | Zoledronate |
Primary outcome
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.
12 secondary outcomes
Percentage of Participants With Skeletal-Related Events (SREs)
Time frame: From Baseline to end of study (up to Week 96)
Time to First SRE
Time frame: From Baseline to end of study (up to Week 96)
Number of SREs for Each Participant
Time frame: From Baseline to end of study (up to Week 96)
Percentage of Participants With Osteonecrosis of Jaw
Time frame: From Baseline to end of study (up to Week 96)
Number of Events of Osteonecrosis of Jaw for Each Participant
Time frame: From Baseline to end of study (up to Week 96)
Percentage of Participants With Zoledronate Dose Reduction
Time frame: From Baseline to end of study (up to Week 96)
Number of Zoledronate Dose Reductions for Each Participant
Time frame: From Baseline to end of study (up to Week 96)
Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)
Time frame: Baseline and Weeks 44, 92
Percent Change From Baseline in Alpha (A) 1-Microglobulin
Time frame: Baseline and Weeks 44, 92
Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)
Time frame: Baseline and Weeks 44, 92
Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline
Time frame: Baseline and Weeks 44, 92
Percent Change From Baseline in CrCl
Time frame: Baseline and Weeks 44, 92
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study chair
Hoffmann-La Roche
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibandronate and Zoledronate in people with Multiple Myeloma, run by Hoffmann-La Roche at 56 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2016.