Claims for Patent: 10,034,872

Summary for Patent: 10,034,872

Title:	Methods of treating multiple myeloma with immunomodulatory compounds in combination with antibodies
Abstract:	Methods of treating, preventing and/or managing multiple myeloma are disclosed. Specific methods encompass the administration of an immunomodulatory compound, e.g., lenalidomide or pomalidomide with an anti-CS1 antibody, e.g., elotuzumab in patients who have received autologous stem cell transplantation.
Inventor(s):	Thakurta; Anjan (Basking Ridge, NJ), Hussein; Mohamed (Odessa, FL), Jacques; Christian (Hamburg, NJ)
Assignee:	Celgene Corporation (Summit, NJ)
Application Number:	14/831,616
Patent Claims:	1. A method of treating multiple myeloma in a patient having multiple myeloma and having received stem cell transplantation, which comprises: a. determining the minimal residual disease (MRD) status of the patient following the stem cell transplantation, wherein the patient has received induction therapy with a compound having the formula: ##STR00825## or a pharmaceutically acceptable salt, solvate or stereoisomer thereof before receiving the stem cell transplantation; and b. wherein if the patient is MRD positive, administering to the patient about 1 to about 50 mg per day of the compound or a pharmaceutically acceptable salt, solvate or stereoisomer thereof, in combination with a therapeutically effective amount of an anti-CS1 antibody. 2. The method of claim 1, wherein the patient has received induction therapy with a combination of the compound and a proteasome inhibitor prior to the stem cell transplantation. 3. The method of claim 1, wherein the multiple myeloma is relapsed, refractory, or relapsed and refractory multiple myeloma. 4. The method of claim 1, wherein the method comprises cyclic administration of the compound. 5. The method of claim 4, wherein the compound is administered for 21 days followed by seven days of rest in a 28 day cycle. 6. The method of claim 1, wherein the compound is administered in an amount of about 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg or 25 mg per day. 7. The method of claim 6, wherein the compound is administered in an amount of about 25 mg per day. 8. The method of claim 6, wherein the compound is administered in an amount of about 10 mg per day. 9. The method of claim 6, wherein the compound is administered in an amount of about 5 mg per day. 10. The method of claim 6, wherein the compound is administered in a capsule in an amount of about 25 mg. 11. The method of claim 1, wherein the compound is administered orally. 12. The method of claim 11, wherein the compound is administered in the form of a capsule or tablet. 13. The method of claim 12, wherein the capsule comprises the compound, lactose anhydrous, microcrystalline cellulose, croscarmellose sodium and magnesium stearate. 14. The method of claim 1, wherein the compound is administered in a capsule in an amount of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg or 25 mg. 15. The method of claim 14, wherein the compound is administered in a capsule in an amount of about 10 mg. 16. The method of claim 14, wherein the compound is administered in a capsule in an amount of about 5 mg. 17. The method of claim 14, wherein the compound is administered in a capsule in an amount of about 2.5 mg. 18. The method of claim 1, wherein the anti-CS1 antibody is a monoclonal antibody. 19. The method of claim 18, wherein the anti-CS1 antibody is elotuzumab. 20. The method of claim 18, wherein the antibody is administered intravenously in an amount of from about 1 to about 1000 mg weekly or every other week. 21. The method of claim 18, wherein the antibody is administered in an amount of about 10 mg/kg. 22. The method of claim 18, wherein the antibody is administered weekly or every other week in a 28 day cycle. 23. The method of claim 18, wherein the antibody is administered on days 1, 8, 15 and 22 in a 28 day cycle. 24. The method of claim 18, wherein the antibody is administered on days 1 and 15 in a 28 day cycle. 25. The method of claim 1, wherein the compound is ##STR00826## and is not a pharmaceutically acceptable salt, solvate or stereoisomer thereof. 26. The method of claim 1, wherein the compound is a pharmaceutically acceptable salt of ##STR00827## 27. The method of claim 1, wherein the compound is a pharmaceutically acceptable solvate of ##STR00828## 28. The method of claim 2, wherein the proteasome inhibitor is bortezomib or carfilzomib. 29. The method of claim 28, wherein the patient has received induction therapy with lenalidomide in combination with bortezomib or carfilzomib. 30. The method of claim 28, wherein the patient has received induction therapy with lenalidomide in combination with bortezomib or carfilzomib, and dexamethasone. 31. The method of claim 1, wherein the stem cell transplantation is autologous stem cell transplantation. 32. The method of claim 1, wherein the stem cell transplantation is hematopoietic stem cell transplantation. 33. The method of claim 1, wherein the stem cell transplantation is peripheral blood stem cell transplantation. 34. The method of claim 22, wherein the patient is further administered with dexamethasone. 35. The method of claim 34, wherein the dexamethasone is administered daily or on weeks when the anti-CS1 antibody is not administered in the cycle.

Details for Patent 10,034,872

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bristol-myers Squibb Company	EMPLICITI	elotuzumab	For Injection	761035	11/30/2015		2039-02-26