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Table 5. Thalidomide Efficacy Studies—Studies of Thalidomide Plus Dexamethasone in Advanced/Refractory/Resistant Multiple Myeloma

Study ID

Thalidomide Dose Daily
[Median length of followup]

No. of Patients, Age, Sex, additional MM characteristics

N

Paraprotein Response

Survival/Other

Phase II

Alexanian, 200364

Quality=1/6

200-800 mg;
Responders maintain Thal 100-200 mg
Non-responders then added Dex 20 mg/m2 x 4d on d1, 9,17
[Median f/u=NS]

45
58 yr
55% M

Relapsed, resistant

43

PPR 50%=26%

Non-responders (n=24) + Dex:
   PPR 50%=40%
   Cumulative PPR 50%=50%

Overall Response (≥25%)=UTD

m protein reduction:
   100%=NS
   ≥90%=NS
   ≥50%=50%
   ≥25-49%=NS

In responders: Median time to remission=4 mo; median duration of remission=about 1 yr

Alexanian, 200364

Quality=1/6

Anagnotopoulos, 200368

Quality 1/6

Two papers with the same data

200-600 mg + Dex 20 mg/m2 x 5d repeated every 15d;
Responders maintained Thal 100-150 mg with Dex x 5d q month
[Median f/u=NS]

47
48 yr (31-77)

Relapsed or resistant
Median time from initial therapy=36 mo
Other pt and MM characteristics NS

47

Overall Response (≥25%)=54%

m protein reduction:
   100%=13%
   ≥90%=NS
   ≥75%=47%
   ≥50%=NS
   ≥25-49%=NS

Median time to remission=2 mo

Median OS=38 mo and "significantly longer in responsive pts"

Bernardeschi, 200469

Quality 2/5

50-400 mg
+Dex 40 mg x4d q mo

20
65.8 yr (50-83)
55% M

Refractory to prior chemo
Other MM characteristics NS

 

Overall Response (≥25%)=55%

m protein reduction:
   100%=NS
   ≥90%=NS
   ≥50%=55%
   ≥25-49%=NS

Recalculated % based on table

Median OS=37 mo

Dimopoulos, 200170

Quality 3/5

200-400 mg +
Dex 20 mg/m2 x4d on d1, 9 and 17, then qmo x 4d
[Median f/u=NS]

44
67 yr (38-87)
73% M

Refractory, resistant
Median time since initial tx=23.3 mo (2.7-134.4)

44

Overall Response (≥25%)=57%

m protein reduction:
   100%=NS
   ≥90%=NS
   ≥75%=30%
   ≥50%=25%
   ≥25-49%=2%

Med OS=12.6 mo

Med interval between start of Thal and PPR by >50%=1.3 mo (0.75-3.6)

Myers, 200071;
Myers, 200172;
Myers, 200273

Quality 2/5

2 letters of Thal and Thal/dex and 1 followup letter of combined group

50-400 mg

Group 1 (n=9) Thal only @ 200-600 mg71

Group 2 (n=26, n=17 added to Group 1 (10 Thal only and 7 with 4 mg Dex slow taper added for inadequate response)73

Group 3 (n=27, addition of 1 to Group 3 not specified) — in this report a total of 17 had received Dex (dose unspecified)73
[16 mo]

27
72 yr (51-90)
67% M

Relapsed after prior chemo

27

Thal=10
Thal/Dex=17

Dex added if no response to Thal alone

ORR both groups (≥50%)=63%

Thal only:
   ORR=37%:
   100%=NS
   >75%=15%
   >50%=22%
   ≥25-49%=NS

Thal + Dex:
   ORR=
   100%=NS
   >75%=0
   >50%=26%
   ≥25-49%=NS

Median duration of response:
   Thal=16 mo (3-22)
   Thal/Dex=7.5 mo (3-12)

Palumbo, 200174

Quality 2/5

100 mg + Dex 40 mg/d x4d q mo
[8 mo]

77
65 yr

Gender not specified
Refractory or relapsed
Median time since dx=46 mo
Stage III=43%
IgG=60%
IgA=27%

77

Overall Response (≥25%)=69%

m protein reduction:
   100%=3%
   ≥90%=NS
   ≥75%=18%
   ≥50%=23%
   ≥25-49%=25%

Thal ↓100 to 50 mg=4%

Median time to response=4.2 mo (0.6-10.2)

Med TTP=12 mo

OS not reached and 91% of pts still alive

Palumbo, 200475

Quality 6/6

50-100 mg
+Dex 40 mg d1-4 qmo
Historical controls not well matched
Duration of Thal tx=4-36 mo

120
62 yr (range=NS)

Relapsed/refractory
Not randomized

Compared with matched controls β2M & Durie-Salmon stage treated with conventional chemo=CC

Median duration since dx:
With one prior chemo line:
Thal/Dex=23 mo
CC=18 mo
With ≥2 chemo lines:
Thal/Dex=60 mo
CC=55 mo

120

With 1 chemo line:
Thal/Dex=62
CC=82

After ≥2 chemo lines:
Thal/Dex=58
CC=38

After 1 line of prior chemo:
   Thal/Dex vs. CC
   ORR (≥25%)=56% vs. 43%

m protein reduction:
   100%=NS
   ≥90%=NS
   ≥75%=27% vs. 19%
   ≥50%=29% vs. 27%
   ≥25-49%=NS

After >2 chemo lines:
   Thal/Dex vs. CC
   ORR (≥25%)=46% vs. 42%

m protein reduction:
   100%=NS
   ≥90%=NS
   ≥75%=21% vs. 17%
   ≥50%=25% vs. 25%
   ≥25-49%=NS

Median time to maximal response to Thal/Dex=4 mo (0.5-21)

Maximal response to Thal/Dex occurred:
   Within 2 mo=33%
   After 3 mo=17%
   After 4 mo=14%
   After 6 mo=26%
   After 9 mo=11%

PFS: CC=11 mo
   Thal/Dex=12 mo (p=not sig)

OS: CC=21 mo
   Thal/Dex=27 mo (p=0.05)

Median f/u @ 18 mo:

*Reece, 2004 (ASH 4934)76

Quality*

50-400 mg
Med Thal dose=150mg
Thal ± CS=
Pulse Prednisone 50-100 mg q2d (N=15) or Dexamethasone (N=14)
[Median duration of therapy=7 mo (1.5-19+)]

33
73 yr (70-88)

4=Thal alone
29=Thal + CS
Newly diagnosed=6%
Stage III=76%
IgG=61%
IgA=30%
B-J protein=3%

29

Overall Response (≥25%)=57%

m protein reduction:
   100%=NS
   ≥90%=NS
   ≥75%=NS
   ≥50%=42%
   ≥25-49%=15%

OS @ 1 yr=80%

OS @ 2 yr=55%

PFS @ 1 yr=42%

PFS @ 1 yr=20%

Tosi, 2004135

Quality 4/5

100-400 mg
Thal only=8 pt
Thal + Dex 40mg/d x 4d q month=12 pt
[13 mo]

20
65.8 yr (54-76)
75% M

Stage III relapsed/refractory and renal failure (creat >130 mmol/L and creat clearance <60 ml/min)
Hemodialysis=15%
Med time from dx to Thal=34 mo (2-120)
Previous autoSCT=45%

20

Overall Response (≥25%)=75%

m protein reduction:
   100%=NS
   ≥90%=NS
   ≥75%=NS
   ≥50%=45%
   ≥25-49%=30%

Median response duration=7 mo (2-24)

80% of responders (12/15) recovered renal function creat <130 mmol/L

Mean OS=7 mo

At 13 mo f/u 8/15 responders with disease progression

Abbreviations: *=abstract, autoSCT=Autologous stem cell transplant, B-J=Bence-Jones protein, CI=Confidence Intervals, CR=Complete Response, creat=creatinine, CS=pulse prednisone, EFS=event free survival, f/u=followup, NS=not stated, OS=overall survival, PFS=progression free survival, PPR=paraprotein reduction, pt(s)=patient(s), SCT=stem cell transplant, TTP=time to progression; UTD=unable to determine

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