The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy

INTERVENTION: Product Name: BHQ880 100mg Product Code: BHQ880 Pharmaceutical Form: Powder for solution for infusion Current Sponsor code: BHQ880 Other descriptive name: BHQ880‐NXA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Velcade 3,5mg powder for solution for injection Product Name: Bortezomib powder for solution for injection Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: bortezomib CAS Number: 179324‐69‐7 Current Sponsor code: bortezomib Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 3.5‐ Product Name: Dexamethasone tablet 2.0mg Product Code: Dexamethasone Pharmaceutical Form: Tablet INN or Proposed INN: Dexamethasone CAS Number: 50‐02‐2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐ CONDITION: Patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy ; MedDRA version: 14.0 Level: HLT Classification code 10028229 Term: Multiple myelomas System Organ Class: 10005329 ‐ Blood and lymphatic system disorders Therapeutic area: Diseases [C] ‐ Blood and lymphatic diseases [C15] PRIMARY OUTCOME: Main Objective: Assess the effect of BHQ880 compared with placebo on time to first SRE in patients with untreated multiple myeloma and renal insufficiency in combination with bortezomib and dexamethasone Primary end point(s): Time to first SRE from randomization Secondary Objective: ‐ Characterize the safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone; ‐ Characterize the PK profiles of BHQ880 and bortezomib ; ‐ Evaluate the effect of BHQ880 on bone metabolism; ‐ Determine the antimyeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone Timepoint(s) of evaluation of this end point: 18‐month median time to first SRE assumed for the placebo arm SECONDARY OUTCOME: Secondary end point(s): 1) Occurrence of AEs, SAEs, assessments of clinical laboratory values, and vital sign measurements ; 2) BHQ880 and bortezomib PK parameters, including Cmax, Tmax, AUC0‐tlast, t1/2, and accumulation ratio of BHQ880 ; 3) a) Percentage change in BMD, assessed by DXA, from randomization to 12 and 18 months; b) Percentage change in bone strength, assessed by qCT, from randomization to 3 and 6 months; c) Changes in serum DKK1 and DKK4 levels from ; 4) a) ORR (PR + CR); b) Progression‐free survival following initiation of BHQ880 Timepoint(s) of evaluation of this end point: 1) From the start of the study until first SRE from randomization ; 2) Throughout the study until first SRE from randomization ; 3) Throughout the study until first SRE from randomization ; 4) Throughout the study until first SRE from randomization INCLUSION CRITERIA: 1. Confirmed diagnosis of multiple myeloma 2. Life expectancy of more than 6 months in the absence of intervention 3. Must not have received previous or be receiving current antimyeloma therapies 4. Renal insufficiency 5. Recovered from the effects of any prior surgery or radiotherapy. Other protocol‐defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25