Table 1

Patient demographics and baseline characteristics in the VMP arm within subgroups defined by response and by timing of CR

VariableResponse subgroup
Early CRLate CRAll CRPR< PR
No. 73 29 102 136 99 
Male, % 48 34 44 50 60 
White, % 81 86 82 91 90 
Age, y      
    Median 71 70 71 71 74 
    ≥ 75, % 25 34 27 26 42* 
KPS, %      
    ≤ 70 40 38 39 32 36 
    80 32 28 30 29 26 
    ≥ 90 29 34 30 40 37 
β2-microglobulin, mg/L      
    Median 4.40 5.10 4.65 4.00 4.10 
    < 2.5, % 10 7 9 13 13 
    2.5-5.5, % 51 45 49 61 55 
    > 5.5, % 40 48 42† 26 32 
Albumin, g/L      
    Median 34.0 32.0 33.0 33.5 33.0 
    < 3.5, % 53 76 60 57 58 
ISS staging, %      
    I 22 3 17 19 19 
    II 38 48 41 51 47 
    III 40 48 42‡ 29 33 
Region, %      
    North America 15 7 13 9 7 
    Europe 70 76 72 82 82 
    Other 15 17 16 9 11 
Type of MM, % §      
    IgG 34 76 46 71 74 
    IgA 45 17 37 24 13 
    Light chain 16 3 13 3 9 
Creatinine clearance, mL/min      
    Median 61.7 56.7 60.2 57.9 57.6 
    ≤ 30, % 7 7 7 5 5 
    31-60, % 41 48 43 50 48 
    > 60, % 52 45 50 45 46 
High-risk cytogenetics (t(4;14), t(14;16), del17p), % of patients with cytogenetic information‖ 15 17 15 16 13 
VariableResponse subgroup
Early CRLate CRAll CRPR< PR
No. 73 29 102 136 99 
Male, % 48 34 44 50 60 
White, % 81 86 82 91 90 
Age, y      
    Median 71 70 71 71 74 
    ≥ 75, % 25 34 27 26 42* 
KPS, %      
    ≤ 70 40 38 39 32 36 
    80 32 28 30 29 26 
    ≥ 90 29 34 30 40 37 
β2-microglobulin, mg/L      
    Median 4.40 5.10 4.65 4.00 4.10 
    < 2.5, % 10 7 9 13 13 
    2.5-5.5, % 51 45 49 61 55 
    > 5.5, % 40 48 42† 26 32 
Albumin, g/L      
    Median 34.0 32.0 33.0 33.5 33.0 
    < 3.5, % 53 76 60 57 58 
ISS staging, %      
    I 22 3 17 19 19 
    II 38 48 41 51 47 
    III 40 48 42‡ 29 33 
Region, %      
    North America 15 7 13 9 7 
    Europe 70 76 72 82 82 
    Other 15 17 16 9 11 
Type of MM, % §      
    IgG 34 76 46 71 74 
    IgA 45 17 37 24 13 
    Light chain 16 3 13 3 9 
Creatinine clearance, mL/min      
    Median 61.7 56.7 60.2 57.9 57.6 
    ≤ 30, % 7 7 7 5 5 
    31-60, % 41 48 43 50 48 
    > 60, % 52 45 50 45 46 
High-risk cytogenetics (t(4;14), t(14;16), del17p), % of patients with cytogenetic information‖ 15 17 15 16 13 

Response is categorized by EBMT criteria (response-evaluable population, N = 337). Early CR occurred within 24 weeks of treatment; and late CR, after 24 weeks.

CR indicates complete response; EBMT, European Group for Blood and Marrow Transplantation; IgA, immunoglobulin A; IgG, immunoglobulin G; KPS, Karnofsky performance status; MM, multiple myeloma; PR, partial response; and VMP, bortezomib-melphalan-prednisone.

*

P = .0067, Fisher exact test, for difference in rate of age ≥ 75 years between patients achieving CR/PR vs < PR.

†

P = .0229, Fisher exact test, for difference in rate of β2-microglobulin > 5.5 mg/L between patients achieving CR vs PR/< PR.

‡

P = .0610, Fisher exact test, for difference in rate of ISS stage III disease between patients achieving CR vs PR/< PR.

§

P = .0068, Cochran-Mantel-Haenszel test, for difference in MM type between patients achieving CR/PR versus < PR; P < .0001 for CR versus PR/< PR.

‖

There were only 25 response-evaluable patients with high-risk cytogenetics, of whom 7 achieved CR (5 early, 2 late), 12 achieved PR, and 6 had < PR.

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