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Table 2 Maintenance randomisation inclusion and exclusion criteria

From: The MUK five protocol: a phase II randomised, controlled, parallel group, multi-centre trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs. cyclophosphamide, bortezomib (Velcade) and dexamethasone (CVD) for first relapse and primary refractory multiple myeloma

Inclusion criteria for maintenance randomisation
 - Completed at least 24 weeks of CCD treatment in line with the protocol (must have received a minimum of 5 cycles and achieved a maximum response to initial therapy).
 - No evidence of disease progression
 - Adequate hepatic function, with ALT or AST <3 times the upper limit of normal and serum direct bilirubin ≤42.5 μmol/L (2.5 mg/100 ml) within 14 days prior to randomisation
 - Absolute neutrophil count (ANC) ≥1.0 × 109/L within 14 days prior to randomisation. Growth factor support received in the previous cycle of treatment is permissible.
 - Haemoglobin ≥8 g/dL (80 g/L) within 14 days prior to randomisation (participants may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines)
 - Platelet count ≥75 × 109/L (≥50 × 109/L if myeloma involvement in the bone marrow is >50 %) within 14 days prior to randomisation. Platelet support received in the previous cycle of treatment is permissible.
 - Creatinine clearance (CrCl) ≥20 mL/min or plasma creatinine ≤120 μmol/L within 7 days prior to randomisation, either measured or calculated using a standard formula (eg, Cockcroft and Gault)
 - Female participants of child-bearing potential must have a negative pregnancy test prior to treatment and agree to use dual methods of contraception for the duration of the study and for 30 days following completion of study. Male participants must also agree to use a barrier method of contraception for the duration of the study and for 30 days following completion of study if sexually active with a female of child-bearing potential.
Exclusion criteria for maintenance randomisation
 - Uncontrolled hypertension or uncontrolled diabetes
 - Any other clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence
 - Pregnant or lactating females
 - Significant neuropathy (Grades 3–4, or Grade 2 with pain)