| Dosage Schedule for Thal-dex: Month 1 | ||||||
|---|---|---|---|---|---|---|
| D1 Thal (200 mg) + dex (40 mg) |
D2 Thal (200 mg) + dex (40 mg) |
D3 Thal (200 mg) + dex (40 mg) |
D4 Thal (200 mg) + dex (40 mg) |
D5 Thal (200 mg) |
D6 Thal (200 mg) |
D7 Thal (200 mg) |
| D8 Thal (200 mg) |
D9 Thal (200 mg) + dex (40 mg) |
D10 Thal (200 mg) + dex (40 mg) |
D11 Thal (200 mg) + dex (40 mg) |
D12 Thal (200 mg) + dex (40 mg) |
D13 Thal (200 mg) |
D14 Thal (200 mg) |
| D15 Thal (200 mg) |
D16 Thal (200 mg) |
D17 Thal (200 mg) + dex (40 mg) |
D18 Thal (200 mg) + dex (40 mg) |
D19 Thal (200 mg) + dex (40 mg) |
D20 Thal (200 mg) + dex (40 mg) |
D21 Thal (200 mg) |
| D22 Thal (200 mg) |
D23 Thal (200 mg) |
D24 Thal (200 mg) |
D25 Thal (200 mg) |
D26 Thal (200 mg) |
D27 Thal (200 mg) |
D28 Thal (200 mg) |
| Frequency of Mild or Moderate Side Effects with Thalomid at Daily Doses of 50-200 mg in a 2008 Study of 470 Patients | ||||
|---|---|---|---|---|
| Thal-Dex | Dex Alone | |||
| Side Effect | Mild or Moderate | Severe | Mild or Moderate | Severe |
| Peripheral neuropathy | 51% | 3% | 34% | 0 |
| Constipation | 50% | -- | 21% | -- |
| Swelling in the limbs | 34% | -- | 25% | -- |
| Weakness, lack of strength/energy | 24% | 5% | 20% | 2% |
| Dizziness | 22% | -- | 14% | -- |
| Fatigue | 22% | 5% | 16% | 4% |
| Headache | 18% | -- | 20% | -- |
| Insomnia | 18% | -- | 27% | -- |
| Anemia | 16% | 6% | 13% | 3% |
| Fever | 16% | -- | 18% | -- |
| High level of blood sugar (hyperglycemia) | 15% | 6% | 14% | 5% |
| Management of Common Side Effects of Thalomid | |
|---|---|
| If You Have | Your Doctor May |
| Drowsiness | Adjust the schedule or dose. Have you take Thalomid between 7:00 p.m. and 10:00 p.m. Reduce the dose or stop the drug temporarily (if drowsiness is severe). |
| Peripheral neuropathy | Reduce dose when the symptoms begin; if symptoms don’t progress, maintain reduced dose. Stop the drug temporarily (if neuropathy is severe) and restart treatment at a lower dose if symptoms improve. |
| Dizziness | Tell you to avoid sudden change in position from lying or sitting to standing. Adjust the dose if dizziness is severe. |
| Slow pulse | Reduce the dose or stop the drug if heart rate becomes very low or is associated with tiredness or dizziness. |
| Constipation | Tell you to increase fluid intake. Tell you to increase fiber intake. Recommend that you use a stool softener daily. Suggest that you take a laxative as needed. |
| Dry skin/rash | Tell you to use lotion for dry skin. Stop therapy (if a rash develops). Recommend that you use antihistamines or topical steroids to control itching. Evaluate the condition to rule out serious skin reactions, restart treatment with Thalomid at a lower dose, and monitor you closely for skin reactions. |
| Comparison of Three Doses of Thalomid Alone vs. Dexamethasone Alone for the Treatment of Relapsed/Refractory Myeloma in 499 Patients in the OPTIMUM Trial | ||||
|---|---|---|---|---|
| Thalomid (daily dose) | Dexamethasone* | |||
| Outcome | (100 mg) | (200 mg) | (400 mg) | (40 mg) |
| Time to disease progression (mos.) | 6.7 | 7.3 | 9.9 | 6.0 |
| Duration of response (mos.) | 12.7 | 13.1 | 11.6 | 6.5 |
| 1-yr. overall survival (%) | 80 | 83 | 82 | 80 |
*Dexamethasone was taken on days 1-4, 9-12, and 17-20 of four 28-day treatment cycles and then on days 1-4 from the fifth treatment cycle on.
