NCT02739594 · REGISTRY CONDITION SEARCH

Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: TERMINATED
Registry last update: 2016-07-22

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44

→

outcome · POSTED

Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92

→

outcome · POSTED

Percentage of Participants With Skeletal-Related Events (SREs)

→

outcome · POSTED

Time to First SRE

→

outcome · POSTED

Number of SREs for Each Participant

→

outcome · POSTED

Percentage of Participants With Osteonecrosis of Jaw

→

outcome · POSTED

Number of Events of Osteonecrosis of Jaw for Each Participant

→

outcome · POSTED

Percentage of Participants With Zoledronate Dose Reduction

→

outcome · POSTED

Number of Zoledronate Dose Reductions for Each Participant

→

outcome · POSTED

Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)

→

outcome · POSTED

Percent Change From Baseline in Alpha (A) 1-Microglobulin

→

outcome · POSTED

Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)

→

outcome · POSTED

Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline

→

outcome · POSTED

Percent Change From Baseline in CrCl

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants with multiple myeloma will be randomized to receive ibandronate every 4 weeks for a planned duration of 92 weeks.
intervention Names
Drug: Ibandronate
label
Ibandronate
type
EXPERIMENTAL
description
Participants with multiple myeloma will be randomized to receive zoledronate every 4 weeks for a planned duration of 92 weeks.
intervention Names
Drug: Zoledronate
label
Zoledronate
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Ibandronate
description
Ibandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks.
name
Ibandronate
other Names
Bondronat
type
DRUG
arm Group Labels
Zoledronate
description
Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks.
name
Zoledronate
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 89
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
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
description
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.
measure
Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92
time Frame
Baseline, Week 92

secondary Outcomes

description
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.
measure
Percentage of Participants With Skeletal-Related Events (SREs)
time Frame
From Baseline to end of study (up to Week 96)
description
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.
measure
Time to First SRE
time Frame
From Baseline to end of study (up to Week 96)
description
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.
measure
Number of SREs for Each Participant
time Frame
From Baseline to end of study (up to Week 96)
description
The percentage of participants with at least 1 event of osteonecrosis of jaw during the study was reported.
measure
Percentage of Participants With Osteonecrosis of Jaw
time Frame
From Baseline to end of study (up to Week 96)
description
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.
measure
Number of Events of Osteonecrosis of Jaw for Each Participant
time Frame
From Baseline to end of study (up to Week 96)
description
The percentage of participants with at least 1 zoledronate dose reduction during the study was reported.
measure
Percentage of Participants With Zoledronate Dose Reduction
time Frame
From Baseline to end of study (up to Week 96)
description
The number of zoledronate dose reductions was averaged across all participants, including those participants who did not have any dose reductions during the study.
measure
Number of Zoledronate Dose Reductions for Each Participant
time Frame
From Baseline to end of study (up to Week 96)
description
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.
measure
Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)
time Frame
Baseline and Weeks 44, 92
description
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.
measure
Percent Change From Baseline in Alpha (A) 1-Microglobulin
time Frame
Baseline and Weeks 44, 92
description
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.
measure
Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)
time Frame
Baseline and Weeks 44, 92
description
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.
measure
Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline
time Frame
Baseline and Weeks 44, 92
description
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.
measure
Percent Change From Baseline in CrCl
time Frame
Baseline and Weeks 44, 92

Full study description

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.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-53e200a3d213766836d9
requested nct id
NCT02739594
primary nct id
NCT02739594
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
ffab39adc7e872e266a1b1ef8216fa6fae88231ffe8947d9ecfe3bf0e3abea05
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-53e200a3d213766836d9
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT02739594
occurrences
context exact
NCT02739594
end
11
exact text
NCT02739594
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
source json pointer
/studies/658/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
81f6360d0184e38c666ac10e830c5cdf6fd7fec6634821ccace7cb41412c2326
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice