Thalidomide only—newly diagnosed/previously untreated multiple myeloma (Table 2)

Rajkumar, 2001⁴¹

II

200-800

16

4/5

Asymptomatic SMM or IMM

Rajkumar, 2003⁴²

II

50-800

29

3/5

Asymptomatic SMM or IMM

Total # studies in category: 2
Total abstracts (^a): 0

Total # Phase III: 0

Total N: 45

Total with quality 4/6:
1 of 2 (50%)

Thalidomide only—advanced/refractory/resistant multiple myeloma (Table 3)

Barlogie, 2001⁴³

II

200-800

169

4/6

Corso, 2002⁴⁴

II

200

CAVD chemo

21

0/5

Hattori, 2004⁴⁵

II

200-400

44

4/5

Hus, 2001⁴⁶

II

200-400

Historical control

53

3/6

Also with hypocellular BM, pancytopenia

Johnston, 2002⁴⁷

II

50-500

12

3/5

Juliusson, 2000⁴⁸

II

200-800

23

1/5

Kees, 2003⁴⁹

II

50-400

Thal/Dex

Thal/VAD

24

2/6

^aKroeger, 2004 (ASH 1646)⁵⁰

II

100-300

18

^a

Prior to donor lymphocyte infusion

Kumar, 2003⁵¹

II

200-800

32

4/5

Neben, Moehler, Egerer, et al., 2001⁵²

II

100-400

54

3/6

Rajkumar, 2000⁵³

II

200-800

16

3/5

Richardson, 2004⁵⁴

II

200-600

26

3/5

Schey, 2003⁵⁵

II

100-600

69

4/5

Singhal, 1999³⁵

II

200-800

84

5/5

Tosi, 2001⁵⁶

II

100-800

11

3/5

Tosi, 2002⁵⁷

II

100-800

60

2/5

Waage, 2004⁵⁸

II

200-800

65

4/5

Yakoub-Agha, 2000⁵⁹

II

100-800

27

4/5

Yakoub-Agha, 2002⁶⁰

II

50-800

83

6/6

Total # studies in category: 19
Total abstracts (^a): 1

Total # Phase III: 0

Total N: 891

Total with quality 4/6:
8 of 18 (44%)

Thalidomide plus dexamethasone—newly diagnosed/previously untreated multiple myeloma (Table 4)

^aRajkumar, 2004 (ASH 205)⁶¹

^aRajkumar, 2004 (ASCO 6508)⁶²

III

200

Dex

198

^a

RCT of Thal/Dex vs. Dex

^aLudwig, 2005 (ASCO 6537)⁶³

III

200

MP

137

^a

RCT of Thal/dex vs. MP for elderly pts; not completed enrollment.

Alexanian, 2003⁶⁴

II

100-400

NS

1/6

Rajkumar, 2002⁶⁵

II

50-200

50

4/5

^aRajkumar, 2005 (ASCO 6632)⁶⁶

II

200

24

^a

Weber, 2003⁶⁷

II

100-600

Thal

68

3/6

Included pts that received thal alone

Total # studies in category: 6
Total abstracts (^a): 4

Total # Phase III: 2

Total N: 477+

Total with quality 4/6:
1 of 3 (33%)

Thalidomide plus dexamethasone—advanced/refractory/resistant multiple Myeloma (Table 5)

Alexanian, 2003⁶⁴

II

200-800

43

1/6

Mixed clinical settings

Alexanian, 2003⁶⁴

Anagnotopoulos, 2003⁶⁸

II

200-600

47

1/6

1/6

2 reports that combine data

Bernardeschi, 2004⁶⁹

II

100-400

20

2/5

Dimopoulos, 2001⁷⁰

II

200-400

44

3/5

Myers, 2000⁷¹

Myers, 2001⁷²

Myers, 2002⁷³

II

50-400

27

2/5

3 reports about same group of pts

Palumbo, 2001⁷⁴

II

100

77

2/5

Palumbo, 2004⁷⁵

II

50-100

Historical control

120

6/6

^aReece, 2004 (ASH 4934)⁷⁶

II

50-400

Thal vs. Thal/dex

29

^a

Thal/dex could have been thal/dex or thal/prednisone

Tosi, 2004 (ASH 4898)⁷⁷

II

100-400

20

4/5

All with renal failure

Total # studies in category: 9
Total abstracts (^a): 1

Total # Phase III:

0

Total N: 427

Total with quality 4/6:
2 of 9 (22%)

Thalidomide plus other agents—newly diagnosed/previously untreated multiple myeloma (Table 6)

^aFacon, 2004 (ASH 206)⁷⁸

III

400

See comment

200

^a

RCT of MP vs. MP-thal, vs. high dose melphalan + VAD + SCT; not completed enrollment; age 75 yrs

^aPalumbo, 2004 (ASH 207)⁷⁹

III

100

MP

102

^a

RCT of MP vs. MP-thal

^aAlexanian, 2004 (ASH 210)⁸⁰

II

100-200

25

^a

Bortezomib + doxorubicin + thal + dex

^aChanan-Khan, Miller, McCarthy, Koryzna, et al., 2004 (ASH 3463)⁸¹

II

100-200

11

^a

VAD + thal

^aDimopoulos, 2004 (ASH 1482)⁸²

II

300

43

^a

Melphalan + dex + thal; not completed enrollment; age 75 yrs

^aHassoun, 2004 (ASH 2409)⁸³

II

200

30

^a

Doxorubicin + dex followed by thal/dex

^aKlueppelberg, 2004 (ASH 4932)⁸⁴

^aKlueppelberg, 2004 (ASCO 6702)⁸⁵

^aKlueppelberg, 2005 (ASCO 6697)⁸⁶

II

100

29

^a

Thal + dex + zoledronate; 14% HIV+; 3 reports of ongoing study with increasing enrollment

Schutt, 2005⁸⁷

II

200-400

31

5/5

Thal + vincristine + epirubicin + dex

Zervas, 2004⁸⁸

II

200

39

3/5

Thal + VAD + extra dex

Total # studies in category: 9
Total abstracts (^a): 9

Total # Phase III: 2

Total N: 510

Total with quality 4/6:
1 of 2 (50%)

Thalidomide plus other agents—advanced/refractory/resistant multiple myeloma (Table 7)

^aBadros, 2004 (ASH 2400)⁸⁹

II

100-400

30

^a

Oblimerson + dex + thal

^aBibas, 2004 (ASH 4927)⁹⁰

II

100+

30

^a

Thal + dex + zoledronate

^aChanan-Khan, Miller, McCarthy, DiMiceli, et al., 2004 (ASH 2421)⁹¹

II

200

13

^a

Bortezomib + liposomal doxorubicin + thal

Biagi, 2001⁹²

II

200-800

4

1/6

Thal + interferon

Ciepluch, 2002⁹³

II

200-400

13

1/5

Thal + pamidronate

Dimopoulos, 2004⁹⁴

II

400

53

3/5

Cyclophosphamide po + thal + dex

Garcia-Sanz, 2004⁹⁵

II

200-800

66

4/5

Cyclophosphamide po + thal + dex

^aHollmig, 2004 (ASH 2399)⁹⁶

II

50-100

14

^a

Bortezomib + doxorubicin + thal + dex

Kasper, 2004⁹⁷

II

100-400

15

2/5

Thal + pegylated interferon

Kropff, 2003⁹⁸

II

100-400

57

5/5

Thal + dex + iv cyclophosphamide

Mileshkin, Biagi, et al., 2003⁹⁹

II

200-1000

75

5/6

Thal ± interferon

^aMileshkin, 2005 (ASCO 8233)¹⁰⁰

II

Up to 800

66

^a

Thal + celecoxib; QOL outcomes

Offidani, Corvatta, Marconi, Malerba, et al., 2004¹⁰¹

II

100-400

59

0/6

Thal ± melphalan

Offidani, Corvatta, Marconi, Olivieri, et al., 2004¹⁰²

II

100-600

50

6/6

Thal ± melphalan

^aSuvannasankha, 2005 (ASCO 6591)¹⁰³

II

200

37

^a

Thal + po cyclophosphamide + prednisone

^aTeoh, 2004 (ASH 4915)¹⁰⁴

II

50

18

^a

Thal + dex + zoledronate

^aWilliams, 2004 (ASH 1499)^105,106

II

100-200

62

^a

Thal + dex + po cyclophosphamide; includes 24% newly diagnosed pts

^aZangari, Barlogie, Hollmig, et al., 2004 (ASH 1480)¹⁰⁷

II

50-200

Bortezomib

79

^a

Bortezomib + thal

Total # studies in category: 18
Total abstracts (^a): 9

Total # Phase III: 0

Total N: 741

Total with quality 4/6:
4 of 9 (44%)

Thalidomide used as part of the pre or post stem cell transplantation regimen (Table 8)

^aAttal, 2004 (ASH 535)¹⁰⁸

III

NS

See comments

580

^a

Thal for post-SCT maintenance:  randomized btwn no maintenance, pamidronate, pamidronate + thal

Barlogie, 2002¹⁰⁹

III

400

No thal

231

2/6

Randomized to thal vs. no thal at beginning of Total Therapy II program; not completed enrollment; doesn't present unblinded outcomes

^aBarlogie, 2004 (ASH 1483)¹¹⁰

104

^a

Second report of trial; 104 of 668 randomized pts to thal vs. no thal; followup report

Lee, 2003²¹

III

50-400

See comments

236

4/5

DTPACE x 2 then if response randomized to SCT vs. DTPACE x 4; report is for only first 2 cycles of DTPACE

Alexanian, 2002¹¹¹

Alexanian, 2003⁶⁴

II

100-300

21

2/5

1/6

2 reports that combine data

^aSengar, 2005 (ASCO 6731)¹¹²

II?

50

17

^a

Randomized btwn maintenance thal or interferon after SCT; unclear if Phase II or III; no unblinded data presented

^aStewart, 2004 (ASH 335)¹¹³

II

200-400

67

^a

Thal + prednisone for post-SCT maintenance; randomized btwn thal 200 mg and 400 mg

Total # studies in category: 6
Total abstracts (^a): 4

Total # Phase III: 3

Total N: 1152

Total with quality 4/6:
1 of 4 (25%)