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BHQ880

Phase 2

Multiple Myeloma | Small molecule | Oncology |Novartis AG|Trials Updated: Dec 17, 2020

BHQ880 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Aug 2008

BHQ880 target and mechanism

Molecular targetDKK1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment78

FDA Designations

No designations recorded

BHQ880 clinical trials

BHQ880 · 3 trials · 4 indications

Phase 2 2Phase 1 1
NCT01337752Study in Patients With Untreated Multiple Myeloma and Renal InsufficiencyMultiple Myeloma
COMPLETED9 Analytics
NCT01302886Study of BHQ880 in Patients With High Risk Smoldering Multiple MyelomaSmoldering Multiple Myeloma
COMPLETED41 Analytics
PHASE2COMPLETED
Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency
Multiple MyelomaUnlock trial analytics
PHASE2COMPLETED
Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma
Smoldering Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

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
18-month median time to first SRE assumed for the placebo arm

Time to first SRE from randomization

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
Time to first SRE and change in bone markers for bone resorption and formation
9 months minimum treatment with BHQ880 or placebo in combination with zoledronic acid and std anti-myeloma therapy

Secondary Endpoints

safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone
From screening through month 17
Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib
At screening and weeks 1, 2, 4, 7, 10, 11, 13, 16, 25 and 34
Evaluate the effect of BHQ880 on bone metabolism
At screening and at months 3, 6, 12, and 18
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BHQ880 + bortezomib and dexamethasoneEXPERIMENTAL -
BHQ880 Placebo + bortezomib and dexamethasonePLACEBO_COMPARATOR -
BHQ880EXPERIMENTAL -
BHQ880 + zoledronic acidEXPERIMENTALBHQ880 3-40 mg/kg in combination with zoledronic acid 4 mg on day 1 of a 28-day cycle.

Interventions

NameTypeDescription
BHQ880DRUG -
BHQ880 PlaceboDRUGIntravenous infusion
bortezomibDRUGintravenous injection
dexamethasoneDRUGOral
Zoledronic acidDRUG -
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Eligibility Criteria

Age Range55 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

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 radiot...

Countries:United StatesSpainUnited KingdomFranceGermany
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Competitive Landscape -Multiple Myeloma 338 trials

Frequently asked questions about BHQ880

What is BHQ880 used for?

BHQ880 is an investigational medicine being studied in multiple myeloma, including smoldering multiple myeloma and myeloma bone disease. It has been tested in patients with untreated multiple myeloma and renal insufficiency as well. It is not an approved therapy and remains in clinical development.

What does BHQ880 target?

BHQ880 targets DKK1, a protein involved in bone metabolism and myeloma bone disease. BHQ880 is a small molecule inhibitor of DKK1. By acting on this target, it is designed to interfere with DKK1 activity in multiple myeloma and related bone complications.

Who makes BHQ880?

BHQ880 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the clinical studies of BHQ880 in multiple myeloma, smoldering multiple myeloma, and myeloma bone disease.

What phase is BHQ880 in?

BHQ880 has been studied in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The Phase 2 studies in multiple myeloma and smoldering multiple myeloma have been completed, and no trials are currently active.

What clinical trials is BHQ880 in?

BHQ880 has been evaluated in three completed trials. NCT01302886 studied high risk smoldering multiple myeloma, NCT01337752 studied untreated multiple myeloma with renal insufficiency, and NCT00741377 tested BHQ880 with zoledronic acid in relapsed or refractory myeloma bone disease.