MRC Myeloma VII
High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma (Medical Research Council Myeloma VII Trial)
N = 407
- Population
- Previously untreated patients with multiple myeloma younger than 65 years of age.
- Design
- Multicenter study in which 407 patients younger than 65 years of age with previously untreated myeloma were randomly assigned to standard conventional-dose combination chemotherapy or to high-dose therapy and an autologous stem-cell transplant. 401 patients were evaluable for response.
- Arms
- Standard conventional-dose combination chemotherapy (control): Standard conventional-dose combination chemotherapy (regimen not described in the abstract)
- High-dose therapy plus autologous stem-cell transplant (experimental): High-dose therapy and an autologous stem-cell transplant (conditioning not described in the abstract)
- People
- Child JA, Medical Research Council
Δ CR rate+36 pointsΔ median OS+11.8 months
Show the numbers
| Endpoint | Analysis | High-dose therapy plus autologous stem-cell transplant | Standard conventional-dose combination chemotherapy | Effect |
|---|---|---|---|---|
| CR rateEvaluable patients (401 of 407) | primaryChild 2003 | 44% | 8% | P<0.001Partial response 42% versus 40% (P=0.72); minimal response 3% versus 18% (P<0.001). |
| OSIntention to treat (as stated in the abstract for the survival comparison) | primaryChild 2003 | median 54.1 months (44.9–65.2) | median 42.3 months (33.1–51.6) | P=0.04Progression-free survival was also higher in the intensive-therapy group (P<0.001; the abstract gives no values). |
| Endpoint | Analysis | High-dose therapy plus autologous stem-cell transplant | Standard conventional-dose combination chemotherapy | Effect |
|---|---|---|---|---|
| CR rateEvaluable patients (401 of 407) | primaryChild 2003 | 44% | 8% | P<0.001Partial response 42% versus 40% (P=0.72); minimal response 3% versus 18% (P<0.001). |
| OSIntention to treat (as stated in the abstract for the survival comparison) | primaryChild 2003 | median 54.1 months (44.9–65.2) | median 42.3 months (33.1–51.6) | P=0.04Progression-free survival was also higher in the intensive-therapy group (P<0.001; the abstract gives no values). |
- High-dose therapy plus autologous stem-cell transplant (experimental)
- Standard conventional-dose combination chemotherapy (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | High-dose therapy plus autologous stem-cell transplant | Standard conventional-dose combination chemotherapy |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 34 | 64.7% | 57.3% |
| 68 | 41.8% | 32.8% |
| 101 | 27.4% | 19.1% |
| 135 | 17.7% | 10.9% |