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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01302886

Enrollment

Registered

2011-02-24

Start date

2011-05-31

Completion date

2013-11-30

Last updated

2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoldering Multiple Myeloma

Keywords

High risk Smoldering multiple myeloma,, BHQ880,, MM

Brief summary

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.

Interventions

DRUGBHQ880

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	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

Measure	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

Countries

France, Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026