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Table 4. Thalidomide Efficacy Studies—Studies of Thalidomide Plus Dexamethasone in Newly Diagnosed and/or Previously Untreated 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 III

*Rajkumar, 2004 (ASH 205)61;
*Rajkumar, 2004 (ASCO 6508)62

Quality*

2 reports of ongoing trial=only most recent report presented here

200 mg
Thal/Dex vs. Dex alone:
Thal=200 mg.
+ Dex 40 mg d1-4, 9-12, 17-20
Dex alone=same dose
[median f/u=NS]

202
65 yr (range NS)

Gender=NS
Newly diagnosed, untreated, symptomatic MM
Other MM characteristics=NS

Enrollment appears to be complete

198 evaluable at time of report

Overall Response (≥25%)=UTD

m protein reduction:
   100%=NS
   ≥90%=NS
   ≥50%=Thal/Dex=58%
   Dex=42% p=0.0164
   ≥25-49%=NS

Med time to response similar in both arms=1.1 mo

Grade 3 toxicity significantly increased with Thal/dex (p<0.0001):

DVT(3):
   Thal/Dex 18%, Dex 3%

Rash(3):
   Thal/Dex 4%, Dex 0%

Bradycardia(3):
   Thal/Dex 1%, Dex 0%

Neuropathy(3):
   Thal/Dex 4%, Dex 4%

*Ludwig, 2005 (ASCO 6537)63

Quality*

200mg
Thal/Dex vs. MP (melphalan/prednisone)
Thal 200 mg
+Dex 40 mg
d1-4, 15-18 on odd cycles & d1-4 on even cycles
vs.
Melphalan 2.5 mg/kg d1-4 and Prednisone 2 mg/kg d1-4 q 4-6 wks
All pts got zoledronate 4 mg q mo
[median f/u=NS]

137—Enrollment ongoing
(goal n=350)
72 yr

Stage III=58%
Other pt and MM characteristics NS

93 evaluable

Overall Thal/Dex Response=63%
   100% CR=13%
   Near CR=8%
   90%=10%
   50%=17%
   25%=15%

Overall M/P response=62%
   CR=4%
   Near CR=11%
   90%=11%
   50%=19%
   25%=18%

ITT RR=shorter time to response
   Thal/Dex =8 wk
   MP=10 wk
   p=0.01

Shorter best response:
   Thal/Dex=11 wk
   MP=39 wk
   p=0.0047

Pending data on PFS & OS

Analysis per protocol, not ITT:
   Thal/Dex=88%
   MP=68%
   p=0.05

Phase II

Alexanian, 200364

Quality=1/6

100-400 mg + Dex20 mg/m2 x 4d on d1, 9 and 17 q28 days x 3 months
[median f/u=NS]

Not specified
Newly diagnosed

Not specified

Overall Response(≥25%)=85%

m protein reduction:
   100% CR=15%
   ≥75% =70%
   ≥50%=NS
   ≥25-49%=NS

Remission onset 0.7 mo

Rajkumar, 200265

Quality 4/5

50-200mg
+ Dex 40 mg x4d on
d1, 9, 17 (odd cycles) and
d1 (even cycles)
Dose increase to 800 mg halted after 7 pts
Cycles repeated monthly
[median f/u=NS]]

50
61 yr (33-78)
62% M

Newly diagnosed
IgG 66%
IgA 20%
Light chain only=12%

50

Overall Response (≥25%)=92%

m protein reduction:
   100%=NS
   ≥90%=NS
   ≥50%=64%
   ≥25-49%=28%

PPR ≥50%:
   IgG=62%
   IgA=64%
   Light chain only=60%

62% proceeded after 4 cycles of therapy to SCT

*Rajkumar, 2005 (ASCO 6632)66

Quality*

200mg
+ Dex 40 mg x4d on d1, 9, 17 (odd cycles) and d1 (even cycles)
Cycles repeated monthly
[21 mos]

24
65.5 (36-78)
58% M

Newly diagnosed
Not going on to SCT
Stage III=25%
Other MM characteristics=NS

24

Overall Response (≥25%)=54%

m protein reduction:
   100%=8%
   ≥90%=NS
   ≥50%=46%
   ≥25-49%=NS

Med OS=30 mo

Med PFS=19 mo

Med TTP=21 mo

Weber, 200367

Quality 3/6

100-600 mg
28 Thal alone—pts with asymptomatic MM
40 Thal/Dex @ 20mg/m2 x4d on d1, 9, 17 q month
Not randomized
If CR, Thal/Dex d/c’d after >4 months
[25 mo, 9 mo]

68

Sex & Gender=NS
Previously untreated MM

68

Thal alone=28
Thal/Dex=40

Overall Response(≥25%)=36-88%

m protein reduction:
   100%=Thal alone=0%
   Thal/Dex=16%
   ≥75%=Thal alone=36%
   Thal/Dex=72%
   ≥50%=NS
   ≥25-49%=NS

Median time to remission:
   Thal alone=4.2 mo
   Thal/Dex=0.7 mo

Median time to CR:
   Thal/dex=2.3 mo (1.6-2.9)

Prophylactic anticoagulants also given with Thal/Dex:
   Coumadin n=24
   LMW heparin n=16

>80% received thal average daily dose=100-200mg

21/40 treated with thal/dex proceeded to autoSCT—collection was rapid and efficient

Abbreviations: *=abstract, autoSCT=Autologous stem cell transplant, B-J=Bence-Jones protein, CR=Complete Response, CS=pulse prednisone, d/c=discontinued, EFS=event free survival, f/u=followup, ITT=intention to treat, LMW=low molecular weight, NS=not stated, MP=melphalan/prednisone, OS=overall survival, PFS=progression free survival, PPR=paraprotein reduction, pt(s)=patient(s), SCT=stem cell transplant, UTD=unable to determine; TTP=time to progression

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