Skip to main content

Table 3 MUK five secondary endpoint analysis

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

Secondary endpoint Main comparison(s) Analysis method(s)
Key secondary: proportion of participants experiencing ≥ grade 3 neuropathy or ≥ grade 2 neuropathy with pain during initial treatment (a) vs. (b) [S] Logistic regression
(i) Total time spent at each grade of toxicity for ≥ grade 3 neuropathy or ≥ grade 2 neuropathy with pain during initial treatment (a) vs. (b) [NFT] Descriptive summaries
(ii) Complete response rate 24 weeks post initial randomisation (a) vs. (b) [NI] Logistic regression
(iii) Overall response rate 24 weeks post initial randomisation (a) vs. (b) [NI] Logistic regression
(iv) Proportion of participants achieving MRD negative disease at the end of initial treatment (a) vs. (b) [NI] Logistic regression
(v) MRD status of participants at 6 and 12 months following second randomisation and alteration in MRD status (c) vs. (d) [S] Logistic regression
(vi) PFS by MRD status at the end of initial treatment MRD -ve vs. MRD + ve [S] Kaplan-Meier & log-rank test, Cox PH
(vii) Overall response rate within 12 months of initial randomisation (c) vs. (d), (a) vs. (e) [S] Logistic regression
(viii) Maximum response within 12 months of initial randomisation (c) vs. (d), (a) vs. (e) [NFT] Descriptive summaries
(ix) Maximum response overall (c) vs. (d), (a) vs. (e) [NFT] Descriptive summaries
(x) Time to maximum response (c) vs. (d), (a) vs. (e) [S] Kaplan-Meier & log-rank test, Cox PH
(xi) Duration of response (c) vs. (d), (a) vs. (e) [S] Kaplan-Meier & log-rank test, Cox PH
(xii) Overall survival (c) vs. (d), (a) vs. (e) [S] Kaplan-Meier & log-rank test, Cox PH
(xiii) Time to next treatment (c) vs. (d), (a) vs. (e) [NFT] Kaplan-Meier; Cumulative Incidence Functions (competing risks)
(xiv) Toxicity overall, and per cycle of treatment (initial and maintenance treatment) (a) vs. (b), (c) vs. (d) [NFT] Descriptive summaries, graded by Common Terminology Criteria for Adverse Events V4.0
(xv) Treatment compliance (a) vs. (b), (c) vs. (d) [NFT] Descriptive summaries
(xvi) Safety (a) vs. (b), (c) vs. (d) [NFT] Descriptive summaries
  1. NI non-inferiority, S superiority, NFT no formal statistical testing, Cox PH Cox’s proportional hazards model