Recent Updates
Recently added Catalysts

VELCADE/m^2

Phase 3

Mantle Cell Lymphoma | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|Last Updated: Jul 12, 2018

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment487

FDA Designations

No designations recorded

Clinical trial landscape

VELCADE/m^2 · 1 trial · 1 indication

Phase 3 1
NCT00722137Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell LymphomaMantle Cell Lymphoma
COMPLETED487 Analytics
PHASE3COMPLETED
Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma
Mantle Cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Survival (PFS)
Median duration of follow-up of 40 months

PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee.

Secondary Endpoints

Time to Progression (TTP)
Median duration of follow-up of 40 months
Duration of Response
Median duration of follow-up of 40 months
Time to Next Anti-lymphoma Treatment (TTNT)
: Median duration of follow-up of 40 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
R-CHOPACTIVE_COMPARATORRituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, Vincristine 1.4 mg/m\^2, and Prednisone 100 mg/m\^2
VcR-CAPEXPERIMENTALRituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, VELCADE 1.3 mg/m\^2, and Prednisone 100 mg/m\^2

Interventions

NameTypeDescription
Rituximab 375 mg/m^2DRUGIntravenous rituximab 375 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles.
Cyclophosphamide 750 mg/m^2DRUGIntravenous cyclophosphamide 750 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles
Doxorubicin 50 mg/m^2DRUGIntravenous doxorubicin 50 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles
VELCADE 1.3 mg/m^2DRUGIntravenous VELCADE 1.3 mg/m\^2 on Days 1,4,8, and 11of a 21-day (3 week) cycle for 6 cycles
Prednisone 100 mg/m^2DRUGOral prednisone 100 mg/m\^2 on Day 1 to Day 5 of a 21-day (3 week) cycle for 6 cycles
Vincristine 1.4 mg/m^2DRUGIntravenous vincristine 1.4 mg/m\^2 on Day 1of a 21-day (3 week) cycle for 6 cycles. Maximum of 2 mg. Participants could receive 8 cycles if a response was initially documented at the Cycle 6 assessment.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites150

Inclusion Criteria: * Male or female patients 18 years or older (the patient must be at least the legal age limit to be able to give informed consent within the jurisdiction the study is taking place) * Diagnosis of mantle cell lymphoma MCL (Stage II, III or IV) as evidenced by lymph node histology...

Countries:United StatesAustriaBelgiumBrazilCanadaChileChinaColombiaCzechiaGermanyHungaryIndiaIsraelItalyMalaysiaMoroccoPhilippinesPolandPortugalRomaniaRussiaSingaporeSouth AfricaSpainTaiwanThailandTunisiaTurkey (Türkiye)Ukraine
Unlock Eligibility Criteria

Frequently asked questions about VELCADE/m^2

What is VELCADE used for?

VELCADE is a small molecule being studied for use in Non-Small Cell Lung Cancer, Mantle Cell Lymphoma, and Amyloidosis. It is an investigational drug in clinical development for these conditions. VELCADE is developed by Takeda Pharmaceutical Company Limited.

What does VELCADE target?

VELCADE is a small molecule therapeutic. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being evaluated in clinical studies for Non-Small Cell Lung Cancer, Mantle Cell Lymphoma, and Amyloidosis.

Who makes VELCADE?

VELCADE is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials of VELCADE for Non-Small Cell Lung Cancer, Mantle Cell Lymphoma, and Amyloidosis.

What phase is VELCADE in?

VELCADE is in Phase 1 clinical development. It has completed one Phase 1 trial, one Phase 2 trial, and one Phase 3 trial. VELCADE is not approved and remains investigational for the studied indications.

What clinical trials is VELCADE in?

VELCADE has been studied in clinical trials including NCT00298766, an open-label Phase 1/2 study in patients with light-chain (AL)-amyloidosis, and NCT00722137, a Phase 3 study in patients with newly diagnosed Mantle Cell Lymphoma. These trials are completed.

Is VELCADE the same as bortezomib?

VELCADE is also known as bortezomib. Clinical trials refer to the drug as VELCADE for injection and VELCADE (bortezomib). It is being studied for Non-Small Cell Lung Cancer, Mantle Cell Lymphoma, and Amyloidosis.