In these studies, two consolidation courses were administered to complete responders on each arm.  Consolidation therapy consisted of the same drug and daily dosage used for remission induction, but only 5 days of cytarabine and 2 days of Novantrone or daunorubicin were given.  The first consolidation course was administered 6 weeks after the start of the final induction course if the patient achieved a complete remission.  The second consolidation course was generally administered 4 weeks later.  Full hematologic recovery was necessary for patients to receive consolidation therapy.  For the U.S. trial, median granulocyte nadirs for patients receiving Novantrone + cytarabine for consolidation courses 1 and 2 were 10/mm3 for both courses, and for those patients receiving daunorubicin + cytarabine nadirs were 170/mm3 and 260/mm3, respectively.  Median platelet nadirs for patients who received Novantrone + cytarabine for consolidation courses 1 and 2 were 17,000/mm3 and 14,000/mm3, respectively, and were 33,000/mm3 and 22,000/mm3 in courses 1 and 2 for those patients who received daunorubicin + cytarabine.  The benefit of consolidation therapy in ANLL patients who achieve a complete remission remains controversial.  However, in the only well-controlled prospective, randomized multicenter trials with Novantrone in ANLL, consolidation therapy was given to all patients who achieved a complete remission.  During consolidation in the U.S. study, two myelosuppression-related deaths occurred on the Novantrone arm and one on the daunorubicin arm.  However, in the international study there were eight deaths on the Novantrone arm during consolidation which were related to the myelosuppression and none on the daunorubicin arm where less myelosuppression occurred.

Indications and Usage for Novantrone
Novantrone is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses).  Novantrone is not indicated in the treatment of patients with primary progressive multiple sclerosis.

The clinical patterns of multiple sclerosis in the studies were characterized as follows: secondary progressive and progressive relapsing disease were characterized by gradual increasing disability with or without superimposed clinical relapses, and worsening relapsing-remitting disease was characterized by clinical relapses resulting in a step-wise worsening of disability.

Novantrone in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer.

Novantrone in combination with other approved drug(s) is indicated in the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults.  This category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias.