Patient flow-through protocols
. | . | . | Off-study reason, no. . | . | . | . | . | No. (%) in PR†through treatment phase . | No. (%) in CR‡through treatment phase . | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase . | No. at start of phase . | Percent enrollees . | Toxicity . | Progression/relapse . | Death (TRM*) . | Other . | Notes . | . | . | |||
| Total therapy 1 | ||||||||||||
| Enrollment | 231 | 100 | 0 | 0 | 0 | 0 | None | NA | NA | |||
| Induction | 231 | 100 | 8 | 6 | 8 (6) | 14 | None | 145 (63) | 27 (12) | |||
| First transplantation | 195 | 84 | 9 | 9 | 2 (2) | 10 | None | 175 (76) | 60 (26) | |||
| Second transplantation | 165 | 71 | 16 | 2 | 6 (3) | 13 | None | 188 (81) | 84 (36) | |||
| Maintenance | 128 | 55 | 0 | 83 | 15 (2) | 21 | None | 189 (82) | 94 (41) | |||
| Total therapy 2, no thalidomide | ||||||||||||
| Enrollment | 345 | 100 | 0 | 0 | 1 | 7 | None | NA | NA | |||
| Induction | 337 | 98 | 3 | 6 | 8 (9§) | 28 | None | 136 (40) | 34 (10) | |||
| First transplantation | 292 | 85 | 2 | 7 | 2 (2) | 24 | 22 skipped second transplantation | 213 (63) | 79 (23) | |||
| Second transplantation | 235 | 68 | 0 | 5 | 8 (9§) | 23 | 3 skipped consolidation | 249 (74) | 109 (32) | |||
| Consolidation | 218 | 63 | 0 | 17 | 0 | 6 | 12 still on consolidation | 262 (78) | 138 (41) | |||
| Maintenance | 186 | 54 | 0 | 39 | 3 (1) | 3 | 141 still on maintenance | 264 (78) | 145 (43) | |||
. | . | . | Off-study reason, no. . | . | . | . | . | No. (%) in PR†through treatment phase . | No. (%) in CR‡through treatment phase . | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase . | No. at start of phase . | Percent enrollees . | Toxicity . | Progression/relapse . | Death (TRM*) . | Other . | Notes . | . | . | |||
| Total therapy 1 | ||||||||||||
| Enrollment | 231 | 100 | 0 | 0 | 0 | 0 | None | NA | NA | |||
| Induction | 231 | 100 | 8 | 6 | 8 (6) | 14 | None | 145 (63) | 27 (12) | |||
| First transplantation | 195 | 84 | 9 | 9 | 2 (2) | 10 | None | 175 (76) | 60 (26) | |||
| Second transplantation | 165 | 71 | 16 | 2 | 6 (3) | 13 | None | 188 (81) | 84 (36) | |||
| Maintenance | 128 | 55 | 0 | 83 | 15 (2) | 21 | None | 189 (82) | 94 (41) | |||
| Total therapy 2, no thalidomide | ||||||||||||
| Enrollment | 345 | 100 | 0 | 0 | 1 | 7 | None | NA | NA | |||
| Induction | 337 | 98 | 3 | 6 | 8 (9§) | 28 | None | 136 (40) | 34 (10) | |||
| First transplantation | 292 | 85 | 2 | 7 | 2 (2) | 24 | 22 skipped second transplantation | 213 (63) | 79 (23) | |||
| Second transplantation | 235 | 68 | 0 | 5 | 8 (9§) | 23 | 3 skipped consolidation | 249 (74) | 109 (32) | |||
| Consolidation | 218 | 63 | 0 | 17 | 0 | 6 | 12 still on consolidation | 262 (78) | 138 (41) | |||
| Maintenance | 186 | 54 | 0 | 39 | 3 (1) | 3 | 141 still on maintenance | 264 (78) | 145 (43) | |||
Treatment-related mortality (TRM) was defined as death partially attributed to treatment and occurring either while patient was on study or within 2 months of going off study.
Partial response (PR; >75% reduction): denominator for % in remission includes only patients receiving one cycle of protocol therapy.
Complete remission (CR; absence of M-protein by immunofixation): denominator for % in remission includes only patients receiving one cycle of protocol therapy.
Two patients (1 during induction and 1 during second transplantation) went off study due to other reasons (patient/physician choice); these were coded as TRM since death was attributable to treatment and occurred within 2 months of going off TT2.