Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma

A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With Intravenous BHQ880, a Fully Human, Anti-Dickkopf1 (DKK1) Neutralizing Antibody in Previously Untreated Patients With High-risk, Smoldering Multiple Myeloma

This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be administered every 28 days in previously untreated patients. Disease assessments will be performed monthly and effects on bone metabolism will be assessed by measurement of serum and urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile of BHQ880 as a single agent and following multiple doses will be obtained.

Inclusion Criteria:

1. Confirmed diagnosis of SMM with high-risk for progression to multiple myeloma

   1. BMPC ≥ 10% and serum M-protein level ≥ 3 g/dL, OR
   2. BMPC ≥ 10%, serum M-protein level < 3 g/dL, and an abnormal free light chain ratio of < 0.125 or > 8.0

2. No previous or current anti-myeloma therapies

3. Patients ≥ 18 years of age

4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1

Exclusion Criteria:

1. Previous treatment with IV bisphosphonates (i.e., pamidronate or zoledronic acid
2. Another primary malignant disease that requires systemic treatment
3. Concomitant Paget's disease of bone, uncorrected hyperparathyroidism, or uncontrolled thyroid disease
4. Clinically significant uncontrolled heart disease (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias)
5. Treatment with an investigational product within 28 days before the first dose of study treatment
6. Pregnant or nursing (lactating) women
7. 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 inclusion/exclusion criteria may apply