Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p363
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 363/476)
Character Range: 3194026–3199180

(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.
                                                                                                                                            Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records.
                                                                                                                                            Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
                                                                                                                                            (a) the level of serum monoclonal protein; or
                                                                                                                                            (b) Bence‑Jones proteinuria ‑ the results 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; 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 must be used to determine response, results for either (a) or (b) or (c) should be documented 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) must be documented in the patient's medical records. 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 documented in the patient's medical records.
                                                                                                                                            Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during