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VELCADE Administered by

Phase 3

Multiple Myeloma | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|Last Updated: Oct 10, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment222

FDA Designations

No designations recorded

Clinical trial landscape

VELCADE Administered by · 1 trial · 1 indication

Phase 3 1
NCT00722566A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple MyelomaMultiple Myeloma
COMPLETED222 Analytics
PHASE3COMPLETED
A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Patients With Overall Response (Complete Response + Partial Response)
Over 4 cycles (prior to the addition of dexamethasone)

Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR. Complete response requires disappearance of monoclonal protein from the blood and urine and \<5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks. Partial Response requires ≥50% reduction in serum m-protein for at least 2 determinations at least 6 weeks apart and if present, reduction in 24-hour urinary light chain excretion by either ≥90% or to \<200 mg

Secondary Endpoints

Number of Patients With Complete Response
Over 4 cycles (prior to the addition of dexamethasone)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALVELCADE administered by subcutaneous injection
2ACTIVE_COMPARATORVELCADE administered by intravenous infusion

Interventions

NameTypeDescription
VELCADE Administered by subcutaneous injectionDRUGPatients will receive a 1.3mg/meters(squared)/dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle
VELCADE Administered by intravenous infusionDRUGPatients will receive a 1.3mg/meters(squared) dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Male or female subjects 18 years or older 2. Diagnosis of multiple myeloma 3. Measurable, secretory multiple myeloma defined as serum monoclonal IgG of ≥10 g/L, serum monoclonal IgA or IgE ≥5 g/L, or serum monoclonal IgD ≥0.5g/L; or urine M-protein of ≥200 mg/24 hr 4. Relapse...

Countries:BelgiumFranceGermany
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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 VELCADE Administered by

What is VELCADE used for?

VELCADE is a small molecule drug being studied for the treatment of Multiple Myeloma. It is currently in Phase 3 clinical development and is being developed by Takeda Pharmaceutical Company Limited. The drug is administered by subcutaneous and intravenous routes in clinical trials.

Who makes VELCADE?

VELCADE is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is in Phase 3 clinical development for Multiple Myeloma, an oncology indication. Takeda is conducting clinical trials to evaluate the safety and efficacy of VELCADE in patients with previously treated Multiple Myeloma.

What phase is VELCADE in?

VELCADE is in Phase 3 clinical development. It is being studied for the treatment of Multiple Myeloma. The drug is investigational and has not been approved by regulatory authorities based on the available information. A Phase 3 clinical trial has been completed to evaluate its effects.

What clinical trials is VELCADE in?

VELCADE has one completed Phase 3 clinical trial with the identifier NCT00722566. This study, titled "A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma," enrolled 222 participants in Belgium, France, and Germany. The trial was active-controlled and randomized, with a minimum age of 18 years.

How does VELCADE work?

VELCADE is a small molecule drug being studied for Multiple Myeloma. The specific molecular target of VELCADE has not been disclosed in the available information. The drug is being evaluated in clinical trials to determine its mechanism of action and therapeutic effects in patients with previously treated Multiple Myeloma.

Is VELCADE the same as bortezomib?

VELCADE is the brand name for bortezomib, a proteasome inhibitor used in the treatment of Multiple Myeloma. The drug is being developed by Takeda Pharmaceutical Company Limited. In clinical trials, VELCADE has been studied for its efficacy and safety in patients with previously treated Multiple Myeloma.