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. 2010 Jan 19;28(7):1209–1214. doi: 10.1200/JCO.2009.25.6081

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.

a

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.

b

Tandem transplantation includes patients enrolled onto TT1, TT2, TT3, IFM9902, and IFM 9904 and patients randomly assigned to receive a tandem transplantation on IFM94.

c

Tandem transplantation with thalidomide includes patients enrolled onto TT3 and the thalidomide arm of TT2.

d

Thalidomide available at start of protocol includes patients enrolled onto TT2, TT3, IFM9902, and IFM9904.

e

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.

f

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).

g

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).

h

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).