Multicenter, randomized, double-blind, placebo-controlled study of thalidomide plus dexamethasone compared with dexamethasone as initial therapy for newly diagnosed multiple myeloma
N = 470NCT00057564
- Population
- Patients with untreated symptomatic multiple myeloma.
- Design
- Double-blind, placebo-controlled trial in patients with untreated symptomatic myeloma, randomised to thalidomide plus dexamethasone (thalidomide 50 mg daily, escalated to 100 mg on day 15 and to 200 mg from cycle 2, 28-day cycles) or to placebo plus dexamethasone. Dexamethasone 40 mg was given on days 1-4, 9-12 and 17-20 in cycles 1 to 4 and on days 1-4 from cycle 5. The primary end point was time to progression.
- Primary endpoint
- TTP
- Arms
- Thalidomide plus dexamethasone (experimental, n = 235): Thalidomide 50 mg daily escalated to 200 mg plus dexamethasone 40 mg
- Placebo plus dexamethasone (control, n = 235): Placebo plus dexamethasone 40 mg
- People
- Rajkumar SV
Δ ORR+17 pointsΔ median TTP+16.1 months
Show the numbers
| Endpoint | Analysis | Thalidomide plus dexamethasone | Placebo plus dexamethasone | Effect |
|---|---|---|---|---|
| ORRRandomised patients (analysis population not stated in the abstract) | primaryRajkumar 2008 | 63% | 46% | P<0.001Grade 4 adverse events 30.3% versus 22.8%. |
| TTPRandomised patients (analysis population not stated in the abstract) | primaryRajkumar 2008 | median 22.6 months | median 6.5 months | P<0.001 |
| Endpoint | Analysis | Thalidomide plus dexamethasone | Placebo plus dexamethasone | Effect |
|---|---|---|---|---|
| ORRRandomised patients (analysis population not stated in the abstract) | primaryRajkumar 2008 | 63% | 46% | P<0.001Grade 4 adverse events 30.3% versus 22.8%. |
| TTPRandomised patients (analysis population not stated in the abstract) | primaryRajkumar 2008 | median 22.6 months | median 6.5 months | P<0.001 |
- Thalidomide plus dexamethasone (experimental)
- Placebo plus dexamethasone (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Thalidomide plus dexamethasone | Placebo plus dexamethasone |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 14 | 65.1% | 22.5% |
| 28 | 42.4% | 5.0% |
| 42 | 27.6% | 1.1% |
| 57 | 17.4% | 0.2% |
Appears in
Sources
Rajkumar SV, Rosiñol L, Hussein M, Catalano J, Jedrzejczak W, Lucy L, et al. Multicenter, randomized, double-blind, placebo-controlled study of thalidomide plus dexamethasone compared with dexamethasone as initial therapy for newly diagnosed multiple myeloma. J Clin Oncol. 2008;26(13):2171-7.