Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VELCADE
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. |
| 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. |
| 1 | EXPERIMENTAL | VELCADE |
| Name | Type | Description |
|---|---|---|
| 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. |
| bortezomib | DRUG | - |
| 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: * 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...
VELCADE is a small molecule drug being studied for Mantle Cell Lymphoma, Amyloidosis, and Non-Small Cell Lung Cancer. It is developed by Takeda Pharmaceutical Company Limited (TAK). The drug is currently in Phase 1 clinical development, though it has completed trials in later phases for these indications.
VELCADE is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is a small molecule therapeutic being investigated for rare diseases, including Amyloidosis, as well as for Mantle Cell Lymphoma and Non-Small Cell Lung Cancer.
VELCADE is currently in Phase 1 clinical development. It has completed one Phase 1 trial, one Phase 2 trial, and one Phase 3 trial. The drug is investigational and not yet approved, as it remains under clinical investigation for its studied indications.
VELCADE has completed three clinical trials. NCT00298766 was a Phase 1/2 study in Amyloidosis with 70 participants. NCT00343720 was a Phase 2 study in Non-Small Cell Lung Cancer. NCT00722137 was a Phase 3 study in Mantle Cell Lymphoma with 487 participants. All trials are completed.
VELCADE is the brand name for bortezomib, a small molecule drug. It is being studied for Mantle Cell Lymphoma, Amyloidosis, and Non-Small Cell Lung Cancer. The drug is developed by Takeda Pharmaceutical Company Limited and is currently in Phase 1 clinical development.
VELCADE is a small molecule drug that targets the proteasome, a cellular complex that degrades proteins. By inhibiting this target, it affects cancer cell growth. It is being studied for Mantle Cell Lymphoma, Amyloidosis, and Non-Small Cell Lung Cancer by Takeda Pharmaceutical Company Limited.