Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p234
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 234/476)
Character Range: 2265464–2271942

of 24‑hour urinary light chain M protein excretion; or
                                                                                                                                            (c) the serum level of free kappa and lambda light chains; or
                                                                                                                                            (d) bone marrow aspirate or trephine ‑ the percentage of plasma cells; or
                                                                                                                                            (e) if present, the size and location of lytic bone lesions (not including compression fractures); or
                                                                                                                                            (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT‑scan; or
                                                                                                                                            (g) if present, the level of hypercalcaemia, corrected for albumin concentration.
                                                                                                                                            As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo‑secretory or non‑secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient's medical records.
                                                                                                                                            All reports must be documented in the patient's medical records.
                                                                                                                                            If the application is submitted through HPOS form upload or mail, it must include:
                                                                                                                                            (i) A completed authority prescription form; and
                                                                                                                                            (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                       C13787                                                               Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment until progression in patients initiated on dual combination therapy (this drug and dexamethasone), or, in patients initiated on triple therapy (this drug, bortezomib and dexamethasone during treatment cycles 1 up to 8) and are now being treated with treatment cycle 9 or beyond
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.
                                                                                                                                            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;