Table 1 Baseline patient and treatment characteristics.

From: Bortezomib-based induction, high-dose melphalan and lenalidomide maintenance in myeloma up to 70 years of age

Characteristics

S1 (N = 353)

S2 (N = 107)

S3 (N = 141)

p

 

n/%

n/%

n/%

 

Sex

  Male

205/58.1

64/59.8

83/58.9

0.94

  Female

148/41.9

43/40.2

58/41.1

Age in years

  Median (range)

54 (32–60)

63 (61–65)

68 (66–70)

–

WHO performance status

  0

162/45.9

44/41.1

46/32.6

0.22

  1

156/44.2

53/49.5

76/53.9

  2

25/7.1

9/8.4

13/9.2

  3

5/1.4

1/0.9

4/2.8

  Unknown

5/1.4

0/0.0

2/1.4

 

Heavy chain isotype

  IgG

209/59.2

65/60.8

90/63.8

0.53

  IgA

77/21.8

17/15.9

29/20.6

  LCD

62/17.6

24/22.4

19/13.5

  IgD

5/1.4

1/0.9

3/2.1

Light chain isotype

  Kappa

233/66.0

69/64.5

102/72.3

0.31

  Lambda

120/34.0

38/35.5

39/27.7

Calcium elevation (calcium > 2.65 mmol/l)

  Yes

45/12.8

17/15.9

18/12.8

0.68

Renal insufficiency (creatinine > 177 μmol/l)

  Yes

44/12.5

17/15.9

22/15.6

0.54

Anemia (Hb < 10 g/dl or 2 g/dl < normal)

  Yes

179/50.7

55/51.4

78/55.3

0.65

Bone disease (lytic lesionsa)

  Yes

316/89.5

99/92.5

127/90.1

0.69

ISS stage

  I

145/41.1

44/41.1

41/29.1

0.04

  II

122/34.6

29/27.1

55/39.0

  III

86/24.4

34/31.8

45/31.9

Revised ISS stage

  I

85/27.4

33/35.1

30/22.7

0.15

  II

184/59.4

46/48.9

87/65.9

  III

41/13.2

15/16.0

15/11.4

Adverse cytogenetics

  del 17p13

   done

321

93

135

0.40

  positive (% of done)

42/13.1

8/8.6

13/9.6

 t (4;14)

  done

316

94

134

0.10

  positive (% of done)

39/12.3

6/6.4

9/6.7

 gain 1q21 (>3 copies)

  done

310

92

134

0.56

  positive (% of done)

30/9.7

8/8.7

17/12.7

 t (14;16)

  done

306

93

131

0.88

  positive (% of done)

10/3.3

2/2.1

3/2.3

 anyb

  done

301

90

132

0.21

  positive (% of done)

96/31.9

20/22.2

36/27.3

LDH (serum)

  ≤ULN

298/84.4

89/84.0

122/87.1

0.71

  >ULN

55/15.6

17/16.0

18/12.9

Glomerular filtration rate (serum, ml/min)

  Median (range)

104 (6–232)

82 (14–154)

76 (14–152)

<0.001

 Any previous/concomitant disease

  Yes

317/89.8

100/93.5

136/96.5

0.04

Cardiac and vascular disorders

  0–1

315/89.2

78/72.9

100/70.9

<0.001

  >1

38/10.8

29/27.1

41/29.1

Induction therapy (assigned by randomization)

  PAd

174/49.3

46/43.0

79/56.0

0.11

  VCD

179/50.7

61/57.0

62/44.0

Maintenance therapy strategy (assigned by randomization)

  LEN-2Y

169/47.9

58/54.2

73/51.8

0.46

  LEN-CR

184/52.1

49/45.8

68/48.2

  1. Bold p values depict a statistically significant result.
  2. ISS International Staging System, WHO World Health Organization, LDH lactate dehydrogenase, >ULN greater than the upper level of normal range, LCD light chain disease, IgG/A immunoglobulin G/A, hb hemoglobin, LEN lenalidomide, PAd bortezomib/doxorubicine/dexamethasone induction therapy, VCD bortezomib, cyclophosphamide, dexamethasone induction therapy, LEN-2Y (study arms A1 + A2) continuous lenalidomide maintenance for 2 years, LEN-CR (study arms B1 + B2) lenalidomide maintenance for 2 years, if no complete response (CR) was achieved.
  3. aor myeloma-related osteopenia/osteoporosis.
  4. bat least one high-risk aberration, including del 17p13, t (4;14), t(14;16) or gain 1q21 > 3 copies. ISS and revised ISS were calculated according to Greipp et al. [25] and Palumbo et al. [26].
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