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Details for Patent: 8,722,647

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Details for Patent: 8,722,647

Title:Methods for treating amyloidosis using 4-(amino)-2-(2,6-Dioxo(3-piperidyl))- isoindoline-1,3-dione
Abstract: Methods of treating, preventing and/or managing cancer as well as and diseases and disorders associated with, or characterized by, undesired angiogenesis are disclosed. Specific methods encompass the administration of an immunomodulatory compound alone or in combination with a second active ingredient. The invention further relates to methods of reducing or avoiding adverse side effects associated with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy which comprise the administration of an immunomodulatory compound. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.
Inventor(s): Zeldis; Jerome B. (Princeton, NJ)
Assignee: Celgene Corporation (Summit, NJ)
Filing Date:May 30, 2012
Application Number:13/483,832
Claims:1. A method of treating amyloidosis, which comprises administering to a patient having amyloidosis: (a) from about 1 mg to about 5 mg per day of a compound having the formula: ##STR00009## or a pharmaceutically acceptable salt, solvate or stereoisomer thereof, and (b) 40 mg of dexamethasone.

2. A method of treating amyloidosis, which comprises administering to a patient having amyloidosis: (a) from about 1 mg to about 5 mg per day of a compound having the formula: ##STR00010## or a pharmaceutically acceptable salt, solvate or stereoisomer thereof for 21 consecutive days followed by seven consecutive days of rest from administration of said compound in a 28 day cycle, and (b) 40 mg of dexamethasone per week.

3. The method of claim 1 or 2, wherein the amyloidosis is relapsed and refractory amyloidosis.

4. The method of claim 1 or 2, wherein the amyloidosis is refractory amyloidosis.

5. The method of claim 1 or 2, wherein the amyloidosis is relapsed amyloidosis.

6. The method of claim 1 or 2, wherein the patient has received previous therapy.

7. The method of claim 1 or 2, wherein the patient has demonstrated disease progression on previous therapy.

8. The method of claim 1 or 2, wherein the patient has received previous therapy and has demonstrated disease progression on previous therapy.

9. The method of claim 6, wherein the previous therapy is treatment with thalidomide, 3-(4-amino-1-oxo-1,3-dihydro-isoindo1-2-yl)-piperidine-2,6-dione, a proteasome inhibitor, melphalan, cyclophosphamide, or a combination thereof.

10. The method of claim 1 or 2, wherein the compound is administered in an amount of about 4 mg per day.

11. The method of claim 1 or 2, wherein the compound is administered in an amount of about 3 mg per day.

12. The method of claim 1 or 2, wherein the compound is administered in an amount of about 2 mg per day.

13. The method of claim 1 or 2, wherein the compound is administered in an amount of about 1 mg per day.

14. The method of claim 1 or 2, where the dexamethasone is orally administered in an amount of 40 mg once daily on days 1, 8, 15 and 22 of each 28 day cycle.

15. The method of claim 1 or 2, wherein the dexamethasone is orally administered in an amount of about 40 mg once a week of each 28 day cycle.

16. The method of claim 1 or 2, wherein the compound is administered in a capsule.

17. The method of claim 1 or 2, wherein the compound is administered in a tablet.

18. The method of claim 1 or 2, wherein the compound is administered orally in a capsule of 1 mg, 2 mg, 3 mg, or 4 mg.

19. The method of claim 18, wherein the capsule comprises the compound, mannitol and pre-gelatinized starch.

20. A method of treating amyloidosis, which comprises administering to a patient having amyloidosis: (a) from about 1 mg to about 5 mg per day of a compound having the formula: ##STR00011## for 28 consecutive days in a 28 day cycle, and (b) 40 mg of dexamethasone on at least one of days 1-21 of said cycle.

21. The method of claim 20, wherein the compound is administered in an amount of about 4 mg per day.

22. The method of claim 20, wherein the compound is administered in an amount of about 3 mg per day.

23. The method of claim 20, wherein the compound is administered in an amount of about 2 mg per day.

24. The method of claim 20, wherein the compound is administered in an amount of about 1 mg per day.

25. The method of claim 20, wherein the dexamethasone is administered once daily on days 1, 8, 15 and 22 in a 28 day cycle.

26. The method of claim 20, wherein the compound is administered in a capsule of 1 mg, 2 mg, 3 mg, or 4 mg.

27. The method of claim 26, wherein the capsule comprises the compound, mannitol and pre-gelatinized starch.

28. The method of claim 1 or 2, wherein the compound is a pharmaceutically acceptable salt, solvate or stereoisomer.

29. The method of claim 1, 2 or 20, which further comprises administering a therapeutically effective amount of aspirin.
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