Antitumor activity of thalidomide in refractory multiple myeloma
N = 84
- Population
- Previously treated patients with refractory myeloma (76 of 84 with a relapse after high-dose chemotherapy).
- Design
- Single-arm study of oral thalidomide as a single agent in 84 previously treated patients with refractory myeloma (76 with a relapse after high-dose chemotherapy). The starting dose was 200 mg daily, increased by 200 mg every two weeks to 800 mg per day; median treatment duration 80 days (range 2 to 465). Response was assessed on reduction of serum myeloma protein or urinary Bence Jones protein lasting at least six weeks.
- Arms
- Thalidomide (experimental, n = 84): Oral thalidomide 200 mg daily, escalated by 200 mg every 2 weeks to 800 mg daily
- People
- Singhal S
Show the numbers
| Endpoint | Analysis | Thalidomide | Control | Effect |
|---|---|---|---|---|
| ORRTreated patients (denominator not stated in the abstract; 84 were treated)Reduction of serum myeloma protein or urinary Bence Jones protein by at least 25%, lasting at least six weeks; the abstract gives 8 patients with at least 90% reduction (2 complete remissions), 6 with at least 75%, 7 with at least 50% and 6 with at least 25%. | primarySinghal 1999 | 32% | — | Reductions in paraprotein were apparent within two months in 78% of responders. |
| EFSAll treated patients (population not stated in the abstract) | primarySinghal 1999 | 22% at 12 mo | — | Reported as a mean with standard error (22 plus or minus 5 percent), not a confidence interval. |
| OSAll treated patients (population not stated in the abstract) | primarySinghal 1999 | 58% at 12 mo | — | Reported as a mean with standard error (58 plus or minus 5 percent), not a confidence interval. |
| Endpoint | Analysis | Thalidomide | Control | Effect |
|---|---|---|---|---|
| ORRTreated patients (denominator not stated in the abstract; 84 were treated)Reduction of serum myeloma protein or urinary Bence Jones protein by at least 25%, lasting at least six weeks; the abstract gives 8 patients with at least 90% reduction (2 complete remissions), 6 with at least 75%, 7 with at least 50% and 6 with at least 25%. | primarySinghal 1999 | 32% | — | Reductions in paraprotein were apparent within two months in 78% of responders. |
| EFSAll treated patients (population not stated in the abstract) | primarySinghal 1999 | 22% at 12 mo | — | Reported as a mean with standard error (22 plus or minus 5 percent), not a confidence interval. |
| OSAll treated patients (population not stated in the abstract) | primarySinghal 1999 | 58% at 12 mo | — | Reported as a mean with standard error (58 plus or minus 5 percent), not a confidence interval. |