Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Smoldering Multiple Myeloma | Smoldering Multiple Myeloma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BHQ880 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BHQ880
- interventionNames
- Drug: BHQ880
Primary outcomes (1)
- measure
- 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
- timeFrame
- at 6 month
Secondary outcomes (4)
- measure
- Safety and tolerability of BHQ880 in patients with smoldering multiple myeloma by assessing AEs, SAEs, clinical laboratory values
- timeFrame
- From start of study until disease progression
- measure
- Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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