Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p324
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 324/381)
Character Range: 13510489–13519177

of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
                                                                                                                                                                    (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
                                                                                                                                                                    Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
C12847              P12847         CN12847          Elotuzumab                                                                                                      Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be in combination with lenalidomide and dexamethasone; AND
                                                                                                                                                                    Patient must not have developed disease progression while receiving treatment with this drug for this condition.
                                                                                                                                                                    Progressive disease is defined as at least 1 of the following
                                                                                                                                                                    (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
                                                                                                                                                                    (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
                                                                                                                                                                    (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
                                                                                                                                                                    (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
                                                                                                                                                                    (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
                                                                                                                                                                    (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
                                                                                                                                                                    (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
                                                                                                                                                                    Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
C12849              P12849         CN12849          Carfilzomib                                                                                                     Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 12849
                                                                                                                                                                    Continuing treatment - once weekly treatment regimen
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be in combination with dexamethasone; AND
                                                                                                                                                                    Patient must not develop disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction.
                                                                                                                                                                    Progressive disease is defined as at least 1 of the following
                                                                                                                                                                    (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
                                                                                                                                                                    (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of