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 EffectMild or ModerateSevereMild or ModerateSevere
Peripheral neuropathy51%3%34%0
Constipation50%--21%--
Swelling in the limbs34%--25%--
Weakness, lack of strength/energy24%5%20%2%
Dizziness22%--14%--
Fatigue22%5%16%4%
Headache18%--20%--
Insomnia18%--27%--
Anemia16%6%13%3%
Fever16%--18%--
High level of blood sugar (hyperglycemia)15%6%14%5%


Management of Common Side Effects of Thalomid
If You HaveYour Doctor May
DrowsinessAdjust 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 neuropathyReduce 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.
DizzinessTell you to avoid sudden change in position from lying or sitting to standing. Adjust the dose if dizziness is severe.
Slow pulseReduce the dose or stop the drug if heart rate becomes very low or is associated with tiredness or dizziness.
ConstipationTell 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/rashTell 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.)6.77.39.96.0
Duration of response (mos.)12.713.111.66.5
1-yr. overall survival (%)80838280

*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.