Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione
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.
1. A method of treating multiple myeloma, which comprises administering to a patient having multiple myeloma, and which patient has received previous therapy for multiple myeloma, from about 1 mg to about 5 mg per day of a compound having the formula:
or a pharmaceutically acceptable salt, solvate or stereoisomer thereof, wherein the compound is administered in one or more cycles, each of which comprises administering the compound for a period of time followed by a period of rest, wherein the multiple myeloma is relapsed, refractory, or relapsed and refractory multiple myeloma.
2. The method of claim 1 , wherein the patient has demonstrated disease progression on the previous therapy.
3. The method of claim 1 , wherein the previous therapy is treatment with thalidomide, a proteasome inhibitor, or a combination thereof.
4. The method of claim 1 , wherein the previous therapy is treatment with stem cell transplantation.
5. The method of claim 2 , wherein the previous therapy is treatment with a proteasome inhibitor.
6. The method of claim 1 , wherein the patient is 65 years or younger.
7. The method of claim 1 , wherein the patient is older than 65 years.
8. The method of claim 1 , wherein the compound is administered in an amount of about 4 mg per day.
9. The method of claim 1 , wherein the compound is administered in an amount of about 3 mg per day.
10. The method of claim 1 , wherein the compound is administered in an amount of about 2 mg per day.
11. The method of claim 1 , wherein the compound is administered in an amount of about 1 mg per day.
12. The method of claim 1 , wherein the compound is administered as a free base.
13. The method of claim 1 , wherein the compound is administered orally.
14. The method of claim 1 , wherein the compound is administered in a capsule.
15. The method of claim 1 , wherein the compound is administered in a tablet.
16. The method of claim 14 , wherein the capsule comprises the compound, mannitol and pre-gelatinized starch.
17. The method of claim 1 , wherein the compound is administered orally in a capsule of 1 mg, 2 mg, 3 mg, or 4 mg.
18. The method of claim 1 , wherein one cycle comprises four to six weeks.
19. The method of claim 1 , wherein the compound is administered for 21 consecutive days followed by seven consecutive days of rest in a 28 day cycle.
20. The method of claim 1 , wherein the compound is orally administered 4 mg per day on days 1 through 21 of repeated 28-day cycles until disease progression.
21. The method of claim 1 , which further comprises administering a therapeutically effective amount of an additional active agent.
22. The method of claim 21 , wherein the additional active agent is dexamethasone.
23. The method of claim 22 , wherein 40 mg dexamethasone is administered.
24. The method of claim 22 , wherein the dexamethasone is orally administered once daily on days 1, 8, 15 and 22 of a 28 day cycle.
25. The method of claim 22 , wherein the dexamethasone is orally administered once a week of a 28 day cycle.
26. A method of treating multiple myeloma, which comprises administering to a patient having multiple myeloma, and which patient has received previous therapy for multiple myeloma and has demonstrated disease progression on the previous therapy, from about 1 mg to about 5 mg per day of a compound having the formula:
or a solvate thereof, wherein the compound is administered in one or more cycles, each of which comprises administering the compound for a period of time followed by a period of rest.
27. The method of claim 26 , wherein the previous therapy is treatment with a proteasome inhibitor.
28. The method of claim 26 , wherein the compound is administered in an amount of about 4 mg, 3 mg, 2 mg or 1 mg per day.
29. The method of claim 26 , wherein the compound is administered as a free base.
30. The method of claim 26 , wherein the compound is administered orally.
31. The method of claim 26 , wherein the compound is administered in a capsule.
32. The method claim 26 , wherein the compound is administered for 21 consecutive days followed by seven consecutive days of rest in a 28 day cycle.
33. The method of claim 26 , which further comprises administering a therapeutically effective amount of dexamethasone.
34. The method of claim 33 , wherein 40 mg dexamethasone is administered.
35. The method of claim 33 , wherein the dexamethasone is orally administered once daily on days 1, 8, 15 and 22 of a 28 day cycle.