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Label indication • THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). ( 1.1 ) • THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. FDA label
Also known as THALOMID
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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Thalidomide has been studied in multiple myeloma, myelodysplastic syndromes, and HIV infections, including HIV wasting syndrome. Its clinical trial programs have focused on relapsed or refractory multiple myeloma, anemia in myelodysplastic syndromes, and weight loss in adults with HIV wasting syndrome.
Thalidomide binds cereblon (CRBN), a substrate receptor within the DDB1-CUL4A-RBX1 E3 ubiquitin ligase complex. By interacting with this complex, thalidomide acts as an inhibitor that modulates ubiquitin ligase activity and downstream protein degradation, which underlies its activity in multiple myeloma and related conditions.
Thalidomide is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has sponsored the clinical trial programs evaluating thalidomide across multiple myeloma, myelodysplastic syndromes, and HIV-related indications.
Thalidomide is an investigational small molecule that has been studied in Phase 2 and Phase 3 clinical trials. Its development program includes completed studies in relapsed refractory multiple myeloma, myelodysplastic syndromes, and HIV wasting syndrome, with no active trials currently listed.
Completed thalidomide trials include NCT00657488, a Phase 2 study of 100 mg/day versus 400 mg/day in relapsed refractory multiple myeloma, and NCT00452569, a Phase 3 dose study in the same indication. NCT00050843 studied anemia in myelodysplastic syndromes, and NCT00002127 studied HIV wasting syndrome.
Across the four completed trials, 1,194 patients were enrolled. NCT00657488 enrolled 400 patients, NCT00452569 enrolled 499, NCT00050843 enrolled 220, and NCT00002127 enrolled 75. All trials enrolled adults aged 18 years and older and were conducted in multiple countries.