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BHQ880

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

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 221 trials

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about BHQ880

What is BHQ880 used for?

BHQ880 is an investigational drug being studied for use in multiple myeloma bone disease, smoldering multiple myeloma, and multiple myeloma. It is being developed by Novartis AG (NVS) as a small molecule oncology treatment. Clinical trials have evaluated it in patients with relapsed or refractory myeloma, high risk smoldering myeloma, and untreated myeloma with renal insufficiency.

Who makes BHQ880?

BHQ880 is being developed by Novartis AG, which trades under the ticker NVS. The company has sponsored clinical trials of BHQ880 in multiple myeloma and related conditions. All trials of BHQ880 listed in clinical registries are completed, with no active trials currently ongoing.

What phase is BHQ880 in?

BHQ880 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials in multiple myeloma and smoldering multiple myeloma. The drug is investigational and has not been approved by regulatory authorities. All three registered clinical trials for BHQ880 are completed.

What clinical trials is BHQ880 in?

BHQ880 has been studied in three completed clinical trials: NCT00741377, a Phase 1 study in relapsed or refractory myeloma patients; NCT01302886, a Phase 2 study in high risk smoldering multiple myeloma; and NCT01337752, a Phase 2 study in untreated multiple myeloma with renal insufficiency. Total enrollment across these trials was 78 patients.

Is BHQ880 the same as any other drug?

BHQ880 is the primary name used for this investigational drug in clinical trials and regulatory documents. No alternative names have been identified for BHQ880 in the available clinical trial information. The drug is a small molecule being developed by Novartis for multiple myeloma and related bone disease.