Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication VELCADE is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma ( 1.1 ) treatment of adult patients with mantle cell lymphoma ( 1.2 ) 1.1 Multiple Myeloma VELCADE is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma VELCADE is indicated for the treatment of adult patients with mantle cell lymphoma. FDA label
Also known as VELCADE, rifampicin, dexamethasone
Bortezomib · 6 trials · 6 indications
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.
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by \> 50% of previously involved sites from nadir.
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by \> 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years.
Maximum Tolerated Dose (MTD) was defined as the highest dose level that has 0/1 out of 6 patients experiences Dose Limited Toxicity (DLT). MTD is defined separately for QW and BIQ dose cohorts. DLT was defined as adverse events occurring during Cycle 1 and: (1) related to VELCADE, (2) Grade 4 thrombocytopenia or neutropenia, (3) Grade 3 or higher nonhematologic toxicity.
Treatment emergent adverse events observed during outcome measure time frame
Serious treatment emergent adverse events observed during outcome measure time frame
Grade 3/4/5 treatment emergent adverse events observed during outcome measure time frame. Grade is determined according to Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0.
Treatment emergent adverse events observed during outcome measure time frame leading to treatment termination
| Arm | Type | Description |
|---|---|---|
| R-CHOP | ACTIVE_COMPARATOR | Rituximab 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-CAP | EXPERIMENTAL | Rituximab 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 |
| RCHOP | ACTIVE_COMPARATOR | RCHOP \[rituximab, cyclophosphamide, doxorubicin, prednisone\] administered as follows: rituximab 375 mg/m\^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m\^2 IV infusion, doxorubicin 50 mg/m\^2 IV injection and vincristine 1.4 mg/m\^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. |
| Vc-RCHOP | EXPERIMENTAL | Vc-RCHOP \[bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone\] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m\^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m\^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m\^2 IV infusion, doxorubicin 50 mg/m\^2 IV injection and vincristine 1.4 mg/m\^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. |
| 1 | EXPERIMENTAL | VELCADE |
| VELCADE | EXPERIMENTAL | Control arm, bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle. |
| VELCADE + rifampicin | EXPERIMENTAL | Treatment Arm, bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg once daily days 4 to 10 in cycle 3. |
| VELCADE + dexamethasone | EXPERIMENTAL | Treatment arm, bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg once daily days 1 to 4, and 9 to 12 in cycle 3. |
| Name | Type | Description |
|---|---|---|
| bortezomib | DRUG | - |
| Rituximab 375 mg/m^2 | DRUG | Intravenous rituximab 375 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles. |
| Cyclophosphamide 750 mg/m^2 | DRUG | Intravenous cyclophosphamide 750 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles |
| Doxorubicin 50 mg/m^2 | DRUG | Intravenous doxorubicin 50 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles |
| VELCADE 1.3 mg/m^2 | DRUG | Intravenous 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^2 | DRUG | Oral 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^2 | DRUG | Intravenous 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. |
| Rituximab | DRUG | Rituximab IV |
| Cyclophosphamide | DRUG | Cyclophosphamide IV |
| Doxorubicin | DRUG | Doxorubicin IV solution |
| Vincristine | DRUG | Vincristine IV |
| Prednisone | DRUG | Prednisone tablet |
| VELCADE | DRUG | - |
| Alimta | DRUG | - |
| bortezomib, rifampicin | DRUG | bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg once daily days 4 to 10 in cycle 3 |
| bortezomib, dexamethasone | DRUG | bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg once daily days 1 to 4, and 9 to 12 in cycle 3 |
Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: * Male or female * Not a candidate for HDT/SCT due to: age - subject is 65 years or older or in subjects less than 65 years of age - presence of important comorbid condition(s) likely to have a negative i...
Bortezomib is a small molecule proteasome inhibitor developed by Takeda Pharmaceutical Company Limited under the ticker TAK. It is used in the treatment of multiple myeloma, mantle cell lymphoma, non-GCB diffuse large B-cell lymphoma, non-small cell lung cancer, and amyloidosis. It is also known as VELCADE.
Bortezomib targets the proteasome subunits PSMD1, PSMB2, PSMB1, PSMB5, PSMB8, and PSMB9. As an inhibitor, it blocks the activity of these subunits, which are part of the ubiquitin-proteasome pathway. This mechanism is intended to disrupt protein degradation in cancer cells.
Bortezomib is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is responsible for the clinical development and commercialization of the drug, marketed under the brand name VELCADE.
Bortezomib is in Phase 1 clinical development according to current data. It is an investigational agent and has not been approved by the FDA for the indications listed. The drug is being studied in multiple cancer types, including multiple myeloma and mantle cell lymphoma.
Bortezomib has been studied in several completed trials, including NCT00931918 in non-GCB diffuse large B-cell lymphoma, NCT00722137 in mantle cell lymphoma, NCT00608907 in multiple myeloma and non-Hodgkin's lymphoma, and NCT00343720 in non-small cell lung cancer. All trials are completed.
Yes, Bortezomib is also known as VELCADE. VELCADE is the brand name for bortezomib, and the two names refer to the same active ingredient. Other variations such as VELCADE 1.3 mg/m^2 and VELCADE/m^2 are also used to refer to the drug.