This information is for reference purposes only. It was current when produced and may now be outdated. Archive material is no longer maintained, and some links may not work. Persons with disabilities having difficulty accessing this information should contact us at: https://info.ahrq.gov. Let us know the nature of the problem, the Web address of what you want, and your contact information.
Please go to www.ahrq.gov for current information.
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
Return to Document
Proceed to Next Table