Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Thalidomide · 4 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | Oral thalidomide (100mg/day) administered to the patient once daily until progression of the disease and for a maximum of 336 +/- 36 days (12 cycles of 28 +/- 3 days). |
| B | EXPERIMENTAL | Oral thalidomide (200mg/day) administered to the patient once daily until progression of the disease and for a maximum of 336 +/- 36 days (12 cycles of 28 +/- 3 days). |
| C | EXPERIMENTAL | Oral thalidomide (400mg/day) administered to the patient once daily until progression of the disease and for a maximum of 336 +/- 36 days (12 cycles of 28 +/- 3 days). |
| D | ACTIVE_COMPARATOR | High dose oral dexamethasone will be administered at a dose of 40mg/day on days 1-4, 9-12 and 17-20 of each 28-day cycle for cycles 1-4. Beginning with cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg/day on days 1-4 of each 28-day cycle. Dexamethasone will be administered until progression of the disease and for a maximum of 336 +/- 36 days (12 cycles of 28 +/- 3 days). |
| Name | Type | Description |
|---|---|---|
| Thalidomide | DRUG | Oral thalidomide (100mg or 200mg or 400 mg/day) administered to the patient once daily until progression of the disease and for a maximum of 336 + 36 days (12 cycles of 28 +/- 3 days). |
| Dexamethasone | DRUG | High dose oral dexamethasone will be administered at a dose of 40mg/day on days 1-4, 9-12 and 17-20 of each 28-day cycle for cycles 1-4. Beginning with cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg/day on days 1-4 of each 28-day cycle. Dexamethasone will be administered until progression of the disease and for a maximum of 336 +/- 36 days (12 cycles of 28 +/- 3 days). |
Inclusion Criteria: * Male or female patients, aged ≥ 18 years at the time of signing the informed consent form * Patients who have been previously diagnosed with MM who have received between 1 \& 3 prior lines of treatment for their disease, and who require therapy because of disease progression *...
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