Table 1

Baseline demographics and clinical characteristics (N = 266)

CharacteristicValue
Median age, y (range) 63 (37-87) 
Male, n (%) 155 (58) 
Ethnicity, n (%)  
    Black 53 (20) 
    Asian/Pacific Islander 6 (2) 
    White 190 (71) 
    Hispanic 10 (4) 
    Other 7 (3) 
Median time from diagnosis, y (range) 5.4 (0.5-22.3) 
Ig class heavy chain, n (%)  
    IgG 193 (73) 
    IgA 45 (17) 
    IgD 2 (1) 
    Light chain only or not specified 26 (10) 
International Staging System stage, n (%)  
    I 76 (29) 
    II 102 (38) 
    III 81 (31) 
ECOG performance status, n (%)  
    0 69 (26) 
    1 162 (61) 
    2 35 (13) 
Cytogenetic/FISH prognostic markers, n (%)  
    Normal/favorable 159 (60) 
    Unfavorable 75 (28) 
    Unknown/not done 32 (12) 
PN, n (%)*  
    0 60 (23) 
    1 178 (67) 
    2 28 (11) 
Median creatinine clearance, mL/min (range) 70 (16-203) 
Median serum β2-microglobulin, mg/L (range) 4.3 (0.4-20.5) 
Prior lines of therapy, median (range) 5 (1-20) 
    ≥ 4, n (%) 217 (82) 
Refractory to last regimen  
    Progressive disease on therapy 198 (74) 
Progressive disease within 60 d 38 (14) 
    ≤ 25% response 16 (6) 
Prior agents, median (range) 13 (3-45) 
    Bortezomib, n (%) 265 (99.6) 
        In most recent prior regimen, n (%) 132 (50) 
    Immunomodulatory agent, n (%) 266 (100) 
        Lenalidomide, n (%) 249 (94) 
        Thalidomide, n (%) 199 (75) 
        Pomalidomide, n (%) 9 (3) 
    Corticosteroid, n (%) 261 (98) 
    Alkylating agent, n (%) 246 (92) 
    Stem cell transplant, n (%) 198 (74) 
    Anthracycline, n (%) 171 (64) 
CharacteristicValue
Median age, y (range) 63 (37-87) 
Male, n (%) 155 (58) 
Ethnicity, n (%)  
    Black 53 (20) 
    Asian/Pacific Islander 6 (2) 
    White 190 (71) 
    Hispanic 10 (4) 
    Other 7 (3) 
Median time from diagnosis, y (range) 5.4 (0.5-22.3) 
Ig class heavy chain, n (%)  
    IgG 193 (73) 
    IgA 45 (17) 
    IgD 2 (1) 
    Light chain only or not specified 26 (10) 
International Staging System stage, n (%)  
    I 76 (29) 
    II 102 (38) 
    III 81 (31) 
ECOG performance status, n (%)  
    0 69 (26) 
    1 162 (61) 
    2 35 (13) 
Cytogenetic/FISH prognostic markers, n (%)  
    Normal/favorable 159 (60) 
    Unfavorable 75 (28) 
    Unknown/not done 32 (12) 
PN, n (%)*  
    0 60 (23) 
    1 178 (67) 
    2 28 (11) 
Median creatinine clearance, mL/min (range) 70 (16-203) 
Median serum β2-microglobulin, mg/L (range) 4.3 (0.4-20.5) 
Prior lines of therapy, median (range) 5 (1-20) 
    ≥ 4, n (%) 217 (82) 
Refractory to last regimen  
    Progressive disease on therapy 198 (74) 
Progressive disease within 60 d 38 (14) 
    ≤ 25% response 16 (6) 
Prior agents, median (range) 13 (3-45) 
    Bortezomib, n (%) 265 (99.6) 
        In most recent prior regimen, n (%) 132 (50) 
    Immunomodulatory agent, n (%) 266 (100) 
        Lenalidomide, n (%) 249 (94) 
        Thalidomide, n (%) 199 (75) 
        Pomalidomide, n (%) 9 (3) 
    Corticosteroid, n (%) 261 (98) 
    Alkylating agent, n (%) 246 (92) 
    Stem cell transplant, n (%) 198 (74) 
    Anthracycline, n (%) 171 (64) 
*

Based on physical assessment at screening (NCI-CTC scale).

n = 259.

One patient who had not received prior bortezomib was enrolled. The deviation from the inclusion criteria was discovered after the patient had initiated treatment.

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