Clinical trial · Interventional
Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency
A Double-blind, Placebo-controlled, Randomized Phase 2 Study of BHQ880, an Anti-Dickkopf1 (DKK1) Monoclonal Antibody (mAb), in Patients With Untreated Multiple Myeloma and Renal Insufficiency
- 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)
The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone, compared to placebo administered with the combination on the time to first Skeletal Related Event (SRE) on study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Renal Insufficiency | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BHQ880 | Drug | — | UNRESOLVED |
| BHQ880 Placebo | Drug | — | UNRESOLVED |
| bortezomib | Drug | Bortezomib | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BHQ880 + bortezomib and dexamethasone
- interventionNames
- Drug: BHQ880
- Drug: bortezomib
- Drug: dexamethasone
- type
- PLACEBO_COMPARATOR
- label
- BHQ880 Placebo + bortezomib and dexamethasone
- interventionNames
- Drug: BHQ880 Placebo
- Drug: bortezomib
- Drug: dexamethasone
Primary outcomes (1)
- measure
- effect of BHQ880 compared with placebo on time to first Skeletal Related Event (SRE) in patients with untreated multiple myeloma and renal insufficiency in combination with bortezomib and dexamethasone
- timeFrame
- 18-month median time to first SRE assumed for the placebo arm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed diagnosis of multiple myeloma 2. Life expectancy of more than 6 months in the absence of intervention 3. Must not have received previous or be receiving current antimyeloma therapies 4. Renal insufficiency 5. Recovered from the effects of any prior surgery or radiotherapy Exclusion Criteria: 1. Prior IV bisphosphonate therapy at any time or oral bisphosphonate therapy within 4 months of study entry 2. Paget's disease of bone or uncorrected hyperparathyroidism 3. Impaired cardiac function 4. Known HIV, known active hepatitis B, or known or suspected hepatitis C infection 5. Pregnant or nursing (lactating) women, 6. Women of child-bearing potential, UNLESS agreeable to using 2 birth control methods Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available