Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Smoldering Multiple Myeloma

Intervention / Treatment
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* Drug: BHQ880


Participation Criteria
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Eligibility Criteria
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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 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 inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BHQ880<br> | Drug: BHQ880<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (Complete Response + Partial Response + Minimal Response) of patients achieving an objective response (defined according to the IMWG uniform response criteria by the Frequency of response of serum or urine M-protein to BHQ880A |  | at 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of BHQ880 in patients with smoldering multiple myeloma by assessing AEs, SAEs, clinical laboratory values |  | From start of study until disease progression | 
| Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma |  | Throughout the study until disease progression | 
| Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers |  | Throughout the study until disease progression | 
| Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT |  | 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High risk Smoldering multiple myeloma,, BHQ880,, MM