Hematologic responses and outcomes
| . | All patients . | Serum and urine . | Serum only . | Urine only . |
|---|---|---|---|---|
| Best overall response, % | ||||
| n | 399 | 241 | 103 | 55 |
| Objective response | 71.7 | 70.5 | 72.8 | 74.5 |
| No change | 15.8 | 17.0 | 14.6 | 12.7 |
| Progression | 12.3 | 12.4 | 11.7 | 12.7 |
| Unevaluable | 0.3 | 0 | 1 | 0 |
| Months to objective response (among responders), median (range) | 3.4 (0.5-133.9) | 3.4 (0.5-27.8) | 2.6 (1-133.9) | 4.1 (1.1-21.8) |
| Died, n (%) | 95.0 | 97.5 | 90.3 | 92.7 |
| FLC evaluable subset* | ||||
| n | 318 | 208 | 55 | 55 |
| Died, % | 97 | 98 | 95 | 93 |
| ECOG objective response, % | 70 | 70 | 67 | 74 |
| Months to objective response (among responders), median (range) | 3.5 (0.5-27.8) | 3.5 (0.5-27.8) | 3.5 (1.1-25.2) | 4.1 (1.1-21.8) |
| Responses after 2 months* | ||||
| % change of iFLC | −58.1 (−99.8-9953) | −56.7 (−99.8-2233) | −55.9 (−96-122) | −64.1 (−98.9-9953) |
| % change of rFLC | −57.7 (−99.9-9328) | −58.5 (−99.9-1068) | −34.0 (−99.4-1082) | −66.0 (−99.5-9328) |
| % change of dFLC | −58.4 (−319-10 263) | −57.9 (−319-2410) | −58.2 (−105-127) | −64.4 (−99.8-10 263) |
| FLC responder, definition A, % | 58 | 56 | 62 | 62 |
| FLC responder, definition B, % | 43 | 41 | 42 | 49 |
| Paraprotein responder, % (n/N) | 23 (32/139) | 22 (14/63) | 25 (11/44) | 22 (7/32) |
| . | All patients . | Serum and urine . | Serum only . | Urine only . |
|---|---|---|---|---|
| Best overall response, % | ||||
| n | 399 | 241 | 103 | 55 |
| Objective response | 71.7 | 70.5 | 72.8 | 74.5 |
| No change | 15.8 | 17.0 | 14.6 | 12.7 |
| Progression | 12.3 | 12.4 | 11.7 | 12.7 |
| Unevaluable | 0.3 | 0 | 1 | 0 |
| Months to objective response (among responders), median (range) | 3.4 (0.5-133.9) | 3.4 (0.5-27.8) | 2.6 (1-133.9) | 4.1 (1.1-21.8) |
| Died, n (%) | 95.0 | 97.5 | 90.3 | 92.7 |
| FLC evaluable subset* | ||||
| n | 318 | 208 | 55 | 55 |
| Died, % | 97 | 98 | 95 | 93 |
| ECOG objective response, % | 70 | 70 | 67 | 74 |
| Months to objective response (among responders), median (range) | 3.5 (0.5-27.8) | 3.5 (0.5-27.8) | 3.5 (1.1-25.2) | 4.1 (1.1-21.8) |
| Responses after 2 months* | ||||
| % change of iFLC | −58.1 (−99.8-9953) | −56.7 (−99.8-2233) | −55.9 (−96-122) | −64.1 (−98.9-9953) |
| % change of rFLC | −57.7 (−99.9-9328) | −58.5 (−99.9-1068) | −34.0 (−99.4-1082) | −66.0 (−99.5-9328) |
| % change of dFLC | −58.4 (−319-10 263) | −57.9 (−319-2410) | −58.2 (−105-127) | −64.4 (−99.8-10 263) |
| FLC responder, definition A, % | 58 | 56 | 62 | 62 |
| FLC responder, definition B, % | 43 | 41 | 42 | 49 |
| Paraprotein responder, % (n/N) | 23 (32/139) | 22 (14/63) | 25 (11/44) | 22 (7/32) |
Including only those patients with measurable baseline FLC, that is, dFLC of greater than or equal to 5 mg/dL. Except where stated, results are expressed as median (range).
† Percent change equals = 100 × (2-month − baseline)/baseline.