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Details for Patent: 8,759,375

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Details for Patent: 8,759,375

Title:Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione in combination with proteasome inhibitor
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:Jan 14, 2013
Application Number:13/740,969
Claims:1. A method of treating multiple myeloma, which comprises administering to a patient having multiple myeloma: (a) from about 0.1 mg to about 10 mg per day of a compound having the formula: ##STR00009## or a pharmaceutically acceptable salt, solvate or stereoisomer thereof, and (b) a therapeutically effective amount of a proteasome inhibitor, wherein the multiple myeloma is relapsed, refractory, or relapsed and refractory.

2. The method of claim 1, wherein the compound or a pharmaceutically acceptable salt, solvate or stereoisomer thereof is administered in an amount of about 1 mg to about 5 mg per day.

3. The method of claim 1, which further comprises administering a therapeutically effective amount of an additional active agent.

4. The method of claim 3, wherein the additional active agent is dexamethasone, melphalan, doxorubicin, vincristine, prednisone, cyclophosphamide, biaxin, or a combination thereof.

5. The method of claim 3, wherein the additional active agent is dexamethasone.

6. The method of claim 1, which further comprises autologous stem cell transplantation.

7. The method of claim 1, wherein the multiple myeloma is relapsed and refractory multiple myeloma.

8. The method of claim 1, wherein the multiple myeloma is refractory multiple myeloma.

9. The method of claim 1, wherein the multiple myeloma is relapsed multiple myeloma.

10. The method of claim 1, wherein the patient has received previous therapy.

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

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

13. The method of claim 12, wherein the previous therapy is treatment with thalidomide, 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, stem cell transplantation, or a combination thereof.

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

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

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

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

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

19. The method of claim 1, wherein the compound is administered in a capsule.

20. The method of claim 1, wherein the compound is administered in a tablet.

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

22. The method of claim 21, wherein the capsule comprises the compound, mannitol and pre-gelatinized starch.

23. The method of claim 1, wherein the compound is administered for a period of time followed by a period of rest.

24. A method of treating multiple myeloma, which comprises administering to a patient having multiple myeloma: (a) from about 0.1 mg to about 10 mg per day of a compound having the formula: ##STR00010## and (b) a therapeutically effective amount of a proteasome inhibitor, wherein the multiple myeloma is relapsed, refractory, or relapsed and refractory.

25. The method of claim 24, wherein the compound is administered in an amount of about 1 mg to about 5 mg per day.

26. The method of claim 24, which further comprises administering a therapeutically effective amount of an additional active agent.

27. The method of claim 26, wherein the additional active agent is dexamethasone, melphalan, doxorubicin, vincristine, prednisone, cyclophosphamide, biaxin, or a combination thereof.

28. The method of claim 26, wherein the additional active agent is dexamethasone.

29. The method of claim 24, which further comprises autologous stem cell transplantation.

30. The method of claim 24, wherein the compound is administered in an amount of about 4 mg per day.

31. The method of claim 24, wherein the compound is administered in an amount of about 3 mg per day.

32. The method of claim 24, wherein the compound is administered in an amount of about 2 mg per day.

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

34. The method of claim 24, wherein the compound is administered in a capsule of 1 mg, 2 mg, 3 mg, or 4 mg.

35. The method of claim 24, wherein the capsule comprises the compound, mannitol and pre-gelatinized starch.

36. The method of claim 24, wherein the compound is administered for a period of time followed by a period of rest.

37. The method of claim 24, where the multiple myeloma is relapsed and refractory multiple myeloma.
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