Table 3.
Univariate and Multivariate Analyses of Variables Associated With Postrelapse Survival, Including Baseline Characteristics, Length of Initial EFS, and Availability of Thalidomide and Bortezomib
Variable | No./Total No. of Patients | % | Postrelapse Survival |
||
---|---|---|---|---|---|
HR | 95% CI | Pa | |||
Univariate | |||||
TT1 | 164/2,059 | 8 | 0.86 | 0.72 to 1.03 | .098 |
TT2 | 276/2,059 | 13 | 0.88 | 0.75 to 1.04 | .146 |
TT3 | 47/2,059 | 2 | 1.92 | 1.32 to 2.80 | < .001 |
S9321 | 515/2,059 | 25 | 1.03 | 0.92 to 1.16 | .601 |
IFM90 | 139/2,059 | 7 | 1.45 | 1.20 to 1.74 | < .001 |
IFM94 | 326/2,059 | 16 | 1.25 | 1.10 to 1.44 | .001 |
IFM99-02 | 446/2,059 | 22 | 0.63 | 0.54 to 0.74 | < .001 |
IFM99-04 | 146/2,059 | 7 | 1.32 | 1.07 to 1.64 | .009 |
Tandem transplantationb | 1,240/2,059 | 60 | 0.81 | 0.73 to 0.90 | < .001 |
Tandem transplantation with thalidomidec | 161/2,059 | 8 | 1.17 | 0.94 to 1.45 | .151 |
Thalidomide available at start of protocold | 915/2,059 | 44 | 0.79 | 0.71 to 0.89 | < .001 |
Age ≥ 65 years | 1,166/2,050 | 57 | 1.12 | 1.00 to 1.24 | .045 |
Albumin < 3.5 g/dL | 552/1,971 | 28 | 1.19 | 1.06 to 1.34 | .004 |
B2M ≥ 3.5 mg/L | 914/2,003 | 46 | 1.48 | 1.33 to 1.64 | < .001 |
B2M > 5.5 mg/L | 459/2,003 | 23 | 1.61 | 1.42 to 1.82 | < .001 |
Hgb < 10 g/dL | 755/2,010 | 38 | 1.30 | 1.16 to 1.44 | < .001 |
LDH ≥ ULN | 586/1,850 | 32 | 1.35 | 1.20 to 1.52 | < .001 |
EFS ≤ 803 days (median) | 1,030/2,059 | 50 | 1.84 | 1.65 to 2.05 | < .001 |
EFS ≥ 1,280 days (quartile 4) | 515/2,059 | 25 | 0.45 | 0.39 to 0.53 | < .001 |
Multivariate 1e,f | |||||
TT3 | 47/1,777 | 3 | 1.53 | 1.04 to 2.23 | .029 |
IFM90 | 94/1,777 | 5 | 1.27 | 1.01 to 1.61 | .045 |
IFM9902 | 353/1,777 | 20 | 0.57 | 0.47 to 0.69 | < .001 |
Age ≥ 65 years | 948/1,777 | 53 | 1.38 | 1.21 to 1.58 | < .001 |
B2M > 5.5 mg/L | 394/1,777 | 22 | 1.35 | 1.18 to 1.54 | < .001 |
LDH ≥ ULN | 563/1,777 | 32 | 1.29 | 1.14 to 1.46 | < .001 |
EFS ≤ 803 days (median) | 878/1,777 | 49 | 1.43 | 1.25 to 1.64 | < .001 |
EFS > 1,280 days (quartile 4) | 450/1,777 | 25 | 0.57 | 0.47 to 0.69 | < .001 |
Multivariate 2g | |||||
Tandem transplantationb | 1,080/1,777 | 61 | 0.79 | 0.70 to 0.90 | < .001 |
Tandem transplantation with thalidomidec | 161/1,777 | 9 | 1.46 | 1.16 to 1.83 | .001 |
Age > 65 years | 948/1,777 | 53 | 1.30 | 1.15 to 1.47 | < .001 |
B2M > 5.5 mg/L | 394/1,777 | 22 | 1.40 | 1.23 to 1.60 | < .001 |
LDH > ULN | 563/1,777 | 32 | 1.25 | 1.11 to 1.42 | < .001 |
EFS < 803 days (median) | 878/1,777 | 49 | 1.44 | 1.26 to 1.66 | < .001 |
EFS > 1,280 days (quartile 4) | 450/1,777 | 25 | 0.59 | 0.49 to 0.72 | < .001 |
Multivariate 3h | |||||
Thalidomide available at start of protocold | 772/1,777 | 43 | 0.71 | 0.62 to 0.81 | < .001 |
TT3 (bortezomib available at start of protocol) | 47/1,777 | 3 | 2.04 | 1.38 to 3.01 | < .001 |
Age > 65 years | 948/1,777 | 53 | 1.33 | 1.18 to 1.51 | < .001 |
B2M > 5.5 mg/L | 394/1,777 | 22 | 1.42 | 1.25 to 1.62 | < .001 |
LDH > ULN | 563/1,777 | 32 | 1.28 | 1.13 to 1.45 | < .001 |
EFS < 803 days (median) | 878/1,777 | 49 | 1.44 | 1.26 to 1.65 | < .001 |
EFS > 1,280 days (quartile 4) | 450/1,777 | 25 | 0.59 | 0.49 to 0.71 | < .001 |
Abbreviations: EFS, event-free survival; HR, hazard ratio; TT, Total Therapy; IFM, Intergroupe Francophone du Myelome; B2M, β2-microglobulin; Hgb, hemoglobin; LDH, lactate dehydrogenase; ULN, upper limit of normal.
P values were determined using Wald χ2 test in Cox regression. Multivariate results were not statistically significant at P = .05 level. All univariate P values were reported regardless of significance.
Tandem transplantation includes patients enrolled onto TT1, TT2, TT3, IFM9902, and IFM 9904 and patients randomly assigned to receive a tandem transplantation on IFM94.
Tandem transplantation with thalidomide includes patients enrolled onto TT3 and the thalidomide arm of TT2.
Thalidomide available at start of protocol includes patients enrolled onto TT2, TT3, IFM9902, and IFM9904.
Multivariate models used stepwise selection with entry level of P = .1, and variables remained if they met the P = .05 level. A multivariate P > .05 indicates a variable forced into model with significant variables chosen using stepwise selection.
Variables considered for the multivariate 1 analysis included TT2, TT3, IFM90, IFM94, IFM9902, IFM9904, S9321, age ≥ 65 years, albumin < 3.5 g/dL, B2M > 5.5 mg/L, Hgb < 10 g/dL, LDH ≥ ULN, EFS ≤ 803 days (median), and EFS ≥ 1,280 days (quartile 4).
Variables considered for the multivariate 2 analysis included tandem transplantation, tandem transplantation with thalidomide, age ≥ 65 years, albumin < 3.5 g/dL, B2M > 5.5 mg/L, Hgb < 10 g/dL, LDH ≥ ULN, EFS ≤ 803 days (median), and EFS ≥ 1,280 days (quartile 4).
Variables considered for the multivariate 3 analysis included thalidomide available at start of protocol, TT3 (bortezomib available at start of protocol), age ≥ 65 years, albumin < 3.5 g/dL, B2M > 5.5 mg/L, Hgb < 10 g/dL, LDH ≥ ULN, EFS ≤ 803 days (median), and EFS ≥ 1,280 days (quartile 4).