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Table 1a. Details of Included Studies—Thalidomide Efficacy Studies (corresponding to Tables 2-8)

First Author, Year

Trial Phase

Thal dose per day (mg)

Comparator

N

Quality

Comments

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%)

 

a. Presented as peer-reviewed abstract only.

Abbreviations:  autoSCT=autologous stem cell transplantation; BM=bone marrow; btwn=between; CAVD=lomustine + melphalan + etoposide + dexamethasone; chemo=chemotherapy; Dex=dexamethasone; DTPACE: Dex + thal + cisplatin + doxorubicin, cyclophosphamide + etoposide; HIV=human immunodeficiency virus; IMM=indolent multiple myeloma; iv=intravenous; MP= melphalan po + prednisone; N=number; NS=not stated; po=oral; pt(s)= patient(s); QOL=quality of life; RCT=randomized controlled trial; SCT= stem cell transplantation; SMM=smoldering multiple myeloma; Thal= thalidomide; VAD=vincristine + doxorubicin + dexamethasone; vs.=versus; yrs=years.

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