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

Roche

Status and phase: Terminated; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Ibandronate; Drug: Zoledronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02739594

2005-003264-38 (EudraCT Number)

ML18508

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

89 participants in 2 patient groups

Ibandronate

Experimental group

Description:

Participants with multiple myeloma will be randomized to receive ibandronate every 4 weeks for a planned duration of 92 weeks.

Treatment:

Drug: Ibandronate

Zoledronate

Active Comparator group

Description:

Participants with multiple myeloma will be randomized to receive zoledronate every 4 weeks for a planned duration of 92 weeks.

Treatment:

Drug: Zoledronate