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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.