This study will assess the antimyeloma effects of BHQ880 in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma

Conditions: Adults diagnosed with high-risk Smoldering Multiple Myeloma (SMM) and who have not received any previous antimyeloma treatment.
MedDRA version: 16.0Level: HLTClassification code 10028229Term: Multiple myelomasSystem Organ Class: 100000004851
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2010-022029-13-DE

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Confirmed diagnosis of SMM with high-risk for progression to multiple myeloma
BMPC = 10% and serum M-protein level = 3 g/dL, OR
BMPC = 10%, serum M-protein level < 3 g/dL, and an abnormal free light chain ratio of < 0.125 or > 8.0
No previous or current anti-myeloma therapies
Patients = 18 years of age
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1

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 20

Exclusion Criteria

Previous treatment with IV bisphosphonates (i.e., pamidronate or zoledronic acid
Another primary malignant disease that requires systemic treatment
Concomitant Paget's disease of bone, uncorrected hyperparathyroidism, or uncontrolled thyroid disease
Clinically significant uncontrolled heart disease (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias)
Treatment with an investigational product within 28 days before the first dose of study treatment
Pregnant or nursing (lactating) women
Women of child-bearing potential, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method

Other protocol-defined exclusion criteria may apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the overall response rate after BHQ880 treatment in previously untreated patients with high-risk SMM;Secondary Objective: - Characterize the safety and tolerability of BHQ880<br>- Assess the overall response rate after 12 months of BHQ880 treatment in previously untreated patients with high-risk SMM<br>- Characterize single-dose and monthly, repeated-dose PK profile of BHQ880 therapy<br>- Investigate the potential immunogenicity of BHQ880<br>- Evaluate serum DKK1 and DKK4 levels at baseline and following BHQ880 administration<br>- Evaluate the effect of BHQ880 on bone metabolism;Primary end point(s): Frequency of response (minor response or better) 6 months following BHQ880 treatment;Timepoint(s) of evaluation of this end point: at 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Occurrence of AEs, SAEs, assessments of clinical laboratory values, and vital sign measurements<br>2) Frequency of response (minor response or better) 12 months following BHQ880 treatment<br>3) BHQ880 PK parameters, including the Cmax, Tmax, AUC0-tlast, t1/2, and accumulation ratio<br>4) Anti-BHQ880 antibody levels in serum following multiple doses of BHQ880 treatment<br>5) Free serum DKK1 and DKK4 levels at baseline and BHQ880-bound DKK1 and DKK4 levels after BHQ880 administration<br>6) Percentage change in BMD, assessed by DXA, from baseline to 6 and 12 months following initiation of BHQ880;Timepoint(s) of evaluation of this end point: 1) throughout the study<br>2) at 12 months<br>3) throughout the study<br>4) throughout the study<br>5) throughout the study<br>6) at 6 months and 12 months