Methods of treating multiple myeloma using melphalan, prednisone and lenalidomide

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.

1 - 18 . (canceled) 
     
     
         19 . A method of treating multiple myeloma in a human patient which comprises:
 (1) induction therapy which comprises sequentially or simultaneously administering to a patient having multiple myeloma:   (a) melphalan:   (b) prednisone; and   (c) about 5 to about 25 mg per day of a compound of the formula:   
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof:
 (2) followed by maintenance therapy which comprises administering to the patient 5 to about 25 mg per day of the compound or the pharmaceutically acceptable salt thereof until disease progression or unacceptable toxicity. 
 
     
     
         20 . The method of  claim 19 , wherein the multiple myeloma is newly diagnosed multiple myeloma. 
     
     
         21 . The method of  claim 19 , wherein the compound is administered orally. 
     
     
         22 . The method of  claim 19 , wherein the induction therapy comprises nine 28-day cyces. 
     
     
         23 . The method of  claim 19 , wherein the compound is administered in an amount of about 10 mg per day. 
     
     
         24 . The method of  claim 19 , the compound is administered in the form of a capsule. 
     
     
         25 . The method of  claim 24 , wherein the capsule comprises the compound, lactose anhydrous, microcrystalline cellulose, croscarmellose sodium and magnesium stearate. 
     
     
         26 . The method of  claim 19 , wherein the compound is administered in a capsule of 5 mg, 10 mg, 15 mg or 25 mg. 
     
     
         27 . A method of treating multiple myeloma which comprises:
 (1) induction therapy which comprises administering to a patient having multiple myeloma:   (a) melphalan on days 1-4 every 28 days;   (b) prednisone on days 1-4 every 28 days; and   (c) about 5 to about 25 mg per day of a compound of the formula:   
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt hereof, on days 1-21 every 28 days;
 (2) followed by maintenance therapy which comprises administering to the patient 5 to about 25 mg per day of the compound or the pharmaceutically acceptable salt thereof on days 1-21 every 28 days until disease progression or unacceptable toxicity. 
 
     
     
         28 . The method of  claim 27 , wherein the multiple myeloma is newly diagnosed multiple myeloma. 
     
     
         29 . The method of  claim 27 , wherein the compound is administered orally. 
     
     
         30 . The method of  claim 29 , the compound is administered in the form of a capsule. 
     
     
         31 . The method of  claim 30 , wherein the capsule comprises the compound, lactose anhydrous, microcrystalline cellulose, croscarmellose sodium and magnesium stearate. 
     
     
         32 . The method of  claim 27 , wherein the induction therapy comprises nine 28-day cycles. 
     
     
         33 . The method of  claim 27 , wherein the compound is administered in a capsule of 5 mg, 10 mg, 15 mg or 25 mg. 
     
     
         34 . The method of  claim 27 , wherein the compound is administered in a capsule of 10 mg. 
     
     
         35 . A method of treating multiple myeloma which comprises:
 (1) administering to a patient having multiple myeloma:   (a) melphalan on days 1-4 every 28 days;   (b) prednisone on days 1-4 every 28 days; and   (c) about 10 mg per day of a compound of the formula:   
       
         
           
           
               
               
           
         
       
       on days 1-21 every 28 days;
 (2) followed by maintenance therapy which comprises administering to the patient 10 mg per day of the compound on days 1-21 every 28 days after step (1). 
 
     
     
         36 . The method of  claim 35 , wherein the multiple myeloma is newly diagnosed multiple myeloma. 
     
     
         37 . The method of  claim 35 , wherein the compound is administered orally. 
     
     
         38 . The method of  claim 35 , the compound is administered in the form of a capsule. 
     
     
         39 . The method of  claim 38 , wherein the capsule comprises the compound, lactose anhydrous, microcrystalline cellulose, croscarmellose sodium and magnesium stearate. 
     
     
         40 . The method of  claim 35 , wherein the induction therapy comprises nine 28-day cycles. 
     
     
         41 . The method of  claim 35 , wherein the compound is administered in a capsule of 5 mg or 10 mg. 
     
     
         42 . The method of  claim 35 , wherein the compound is administered in a capsule of 10 mg.