Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CC-5013 · 12 trials · 7 indications
An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;
An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;
Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
| Arm | Type | Description |
|---|---|---|
| Lenalidomide 25mg (CC-5013) | EXPERIMENTAL | Oral 25mg daily on Days 1-21 every 28 days |
| CC-5013/Dex | EXPERIMENTAL | CC-5013 (lenalidomide) plus oral high-dose dexamethasone |
| Placebo/Dex | EXPERIMENTAL | Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone |
| CC-5013 plus dexamethasone | EXPERIMENTAL | Arm A: Oral CC-5013 is initiated on Day 1 of Cycle 1 at a dose of 25 mg daily for 21 days every 28 days. Therefore, the subject will take a placebo identical in appearance to the CC-5013 capsule for week 4 of every 28 days. Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral CC-5013 placebo capsules will be administered for 28 days of every cycle. |
| Dexamethasone plus placebo | EXPERIMENTAL | Arm B: Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle. |
| 1 | EXPERIMENTAL | CC-5013 - oral - 30mg daily on days 1-21 every 28 days |
| CC-5013 | EXPERIMENTAL | CC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles) |
| Name | Type | Description |
|---|---|---|
| CC-5013 | DRUG | Oral 25mg daily on Days 1-21 every 28 days. |
| Lenalidomide | DRUG | Oral Lenalidomide 25mg daily on Days 1-21 every 28 days. |
| Dexamethasone | DRUG | Subjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles. |
| CC-5013 plus dexamethasone | DRUG | 25 mg daily for 21 days every 28 days. |
| Dexamethasone plus Placebo | DRUG | Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle. |
| topotecan | DRUG | - |
Inclusion Criteria: * Understand and voluntarily sign an informed consent form. * Age ≥ 18 years at time of signing the informed consent form. * Able to adhere to the study visit schedule and other protocol requirements * Participants with multiple myeloma and were enrolled in either THAL-MM-003, C...
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CC 5013 is an investigational small molecule being studied for multiple conditions including Crohn's Disease, Myelodysplastic Syndromes, Melanoma, Non-Small Cell Lung Cancer, and Multiple Myeloma. It is in Phase 3 clinical development for these indications, though it remains investigational and is not yet approved.
CC 5013 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials of this small molecule across several oncology and inflammatory disease indications.
CC 5013 is in Phase 3 clinical development. It has completed six clinical trials with a total enrollment of 1,433 participants. The drug is investigational and has not been approved by regulatory authorities for any indication.
CC 5013 has completed six clinical trials, including NCT00051116, NCT00065351, NCT00091624, and NCT00424047. These trials studied the drug in multiple myeloma, with the Phase 3 trial NCT00424047 comparing CC 5013 plus dexamethasone versus dexamethasone alone in previously treated patients.
CC 5013 is an investigational small molecule being developed by Bristol-Myers Squibb. It is being studied in multiple myeloma and other conditions. The drug has completed Phase 3 trials but remains in clinical development and is not approved.