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Table 2. Thalidomide Efficacy—Studies of Thalidomide Alone 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 II

Rajkumar, 200141

Quality 4/5

200-800 mg
[12 mo]

16
60 yr (38-75)
56%M
81% IgG
13% IgA
6% light chain only

Previously untreated, asymptomatic SMM or IMM

16

Overall response (≥25%)=81%

m protein reduction:
   100%=16%
   ≥50%=38%
   (95% CI, 18-63%)   
   ≥25-49%=69%
   Stable=19%

[median duration of response not reached @ median 1 yr f/u]

Rajkumar, 200342

Quality 3/5

50-800 mg
[median f/u=NS]

29
61  (40-74)
55% M

Previously untreated, asymptomatic SMM (66%) or IMM (34%)

Reason for dx as "Indolent MM":
   Lytic lesions (n=7)
   Hgb < 11 g/dL (n=6)
   IgG 83%
   IgA 10%

29

Overall response (≥25%)=66%

m protein reduction:
   100%=29%
   ≥50%=34%
   (95% CI, 18-54%)
   ≥25%=66%
   (95% CI, 46-82%)
   Stable=34%

Median time to PR=5 mo ( 2-9)

Median time to progression & median duration of response not reached.

PFS 80% @ 1 yr; 63% @ 2 yr

KM estimated OS @ 2 yr=96%

Abbreviations:  CI=confidence intervals, dL=deciliter, dx=diagnosis, f/u=followup, hgb=hemoglobin, IMM=indolent multiple myeloma,  KM=Kaplan-Meier, OS=overall survival, PFS=progression free survival,  PR=partial response, SMM=smoldering multiple myeloma

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