RRs by IWG 1999 and 2007 criteria at intermediate and final assessments (response-evaluable patient population)
| Assessment time . | N (%) . | ||||
|---|---|---|---|---|---|
| Lenalidomide dose, mg . | Total (N = 19) . | ||||
| 10 (n = 7) . | 15 (n = 3) . | 20 (n = 6) . | 25 (n = 3) . | ||
| IWG 199920 | |||||
| Intermediate (3 mo) | |||||
| CR | 0 | 1 (33.3) | 2 (33.3) | 1 (33.3) | 4 (21.1) |
| CRu | 1 (14.3) | 0 | 0 | 0 | 1 (5.3) |
| PR | 2 (28.6) | 2 (66.7) | 2 (33.3) | 2 (66.7) | 8 (42.1) |
| SD | 3 (42.9) | 0 | 0 | 0 | 3 (15.8) |
| PD | 0 | 0 | 1 (16.7) | 0 | 1 (5.3) |
| Not evaluated | 1 (14.3) | 0 | 1 (16.7) | 0 | 2 (10.5) |
| CRR (CR/CRu) | 1 (14.3) | 1 (33.3) | 2 (33.3) | 1 (33.3) | 5 (26.3) |
| 95% CI | 9.1-51.2 | ||||
| ORR (CR/CRu/PR) | 3 (42.9) | 3 (100.0) | 4 (66.7) | 3 (100.0) | 13 (68.4) |
| 95% CI | 43.4-87.4 | ||||
| End of treatment | |||||
| CR | 1 (14.3) | 2 (66.7) | 3 (50.0) | 2 (66.7) | 8 (42.1) |
| CRu | 2 (28.6) | 1 (33.3) | 0 | 0 | 3 (15.8) |
| PR | 0 | 0 | 0 | 1 (33.3) | 1 (5.3) |
| SD | 0 | 0 | 0 | 0 | 0 |
| PD | 3 (42.9) | 0 | 2 (33.3) | 0 | 5 (26.3) |
| Not evaluated | 1 (14.3) | 0 | 1 (16.7) | 0 | 2 (10.5) |
| CRR (CR/CRu) | 3 (42.9) | 3 (100.0) | 3 (50.0) | 2 (66.7) | 11 (57.9) |
| 95% CI | 33.5-79.7 | ||||
| ORR (CR/CRu/PR) | 3 (42.9) | 3 (100.0) | 3 (50.0) | 3 (100.0) | 12 (63.2) |
| 95% CI | 38.4-83.7 | ||||
| IWG 200721 | |||||
| Intermediate (3 mo) | |||||
| CR | 1 (14.3) | 1 (33.3) | 2 (33.3) | 2 (66.7) | 6 (31.6) |
| PR | 2 (28.6) | 2 (66.7) | 3 (50.0) | 1 (33.3) | 8 (42.1) |
| SD | 2 (28.6) | 0 | 0 | 0 | 2 (10.5) |
| PD | 1 (14.3) | 0 | 1 (16.7) | 0 | 2 (10.5) |
| Not evaluated | 1 (14.3) | 0 | 0 | 0 | 1 (5.3) |
| CRR (CR/CRu) | 1 (14.3) | 1 (33.3) | 2 (33.3) | 2 (66.7) | 6 (31.6) |
| 95% CI | 12.6-56.6 | ||||
| ORR (CR/CRu/PR) | 3 (42.9) | 3 (100.0) | 5 (83.3) | 3 (100.0) | 14 (73.7) |
| 95% CI | 48.8-90.9 | ||||
| End of treatment | |||||
| CR | 3 (42.9) | 3 (100.0) | 2 (33.3) | 3 (100.0) | 11 (57.9) |
| PR | 0 | 0 | 1 (16.7) | 0 | 1 (5.3) |
| SD | 0 | 0 | 0 | 0 | 0 |
| PD | 2 (28.6) | 0 | 2 (33.3) | 0 | 4 (21.1) |
| Not evaluated | 2 (28.6) | 0 | 1 (16.7) | 0 | 3 (15.8) |
| CRR (CR/CRu) | 3 (42.9) | 3 (100.0) | 2 (33.3) | 3 (100.0) | 11 (57.9) |
| 95% CI | 33.5-79.7 | ||||
| ORR (CR/CRu/PR) | 3 (42.9) | 3 (100.0) | 3 (50.0) | 3 (100.0) | 12 (63.2) |
| 95% CI | 38.4-83.7 | ||||
| Assessment time . | N (%) . | ||||
|---|---|---|---|---|---|
| Lenalidomide dose, mg . | Total (N = 19) . | ||||
| 10 (n = 7) . | 15 (n = 3) . | 20 (n = 6) . | 25 (n = 3) . | ||
| IWG 199920 | |||||
| Intermediate (3 mo) | |||||
| CR | 0 | 1 (33.3) | 2 (33.3) | 1 (33.3) | 4 (21.1) |
| CRu | 1 (14.3) | 0 | 0 | 0 | 1 (5.3) |
| PR | 2 (28.6) | 2 (66.7) | 2 (33.3) | 2 (66.7) | 8 (42.1) |
| SD | 3 (42.9) | 0 | 0 | 0 | 3 (15.8) |
| PD | 0 | 0 | 1 (16.7) | 0 | 1 (5.3) |
| Not evaluated | 1 (14.3) | 0 | 1 (16.7) | 0 | 2 (10.5) |
| CRR (CR/CRu) | 1 (14.3) | 1 (33.3) | 2 (33.3) | 1 (33.3) | 5 (26.3) |
| 95% CI | 9.1-51.2 | ||||
| ORR (CR/CRu/PR) | 3 (42.9) | 3 (100.0) | 4 (66.7) | 3 (100.0) | 13 (68.4) |
| 95% CI | 43.4-87.4 | ||||
| End of treatment | |||||
| CR | 1 (14.3) | 2 (66.7) | 3 (50.0) | 2 (66.7) | 8 (42.1) |
| CRu | 2 (28.6) | 1 (33.3) | 0 | 0 | 3 (15.8) |
| PR | 0 | 0 | 0 | 1 (33.3) | 1 (5.3) |
| SD | 0 | 0 | 0 | 0 | 0 |
| PD | 3 (42.9) | 0 | 2 (33.3) | 0 | 5 (26.3) |
| Not evaluated | 1 (14.3) | 0 | 1 (16.7) | 0 | 2 (10.5) |
| CRR (CR/CRu) | 3 (42.9) | 3 (100.0) | 3 (50.0) | 2 (66.7) | 11 (57.9) |
| 95% CI | 33.5-79.7 | ||||
| ORR (CR/CRu/PR) | 3 (42.9) | 3 (100.0) | 3 (50.0) | 3 (100.0) | 12 (63.2) |
| 95% CI | 38.4-83.7 | ||||
| IWG 200721 | |||||
| Intermediate (3 mo) | |||||
| CR | 1 (14.3) | 1 (33.3) | 2 (33.3) | 2 (66.7) | 6 (31.6) |
| PR | 2 (28.6) | 2 (66.7) | 3 (50.0) | 1 (33.3) | 8 (42.1) |
| SD | 2 (28.6) | 0 | 0 | 0 | 2 (10.5) |
| PD | 1 (14.3) | 0 | 1 (16.7) | 0 | 2 (10.5) |
| Not evaluated | 1 (14.3) | 0 | 0 | 0 | 1 (5.3) |
| CRR (CR/CRu) | 1 (14.3) | 1 (33.3) | 2 (33.3) | 2 (66.7) | 6 (31.6) |
| 95% CI | 12.6-56.6 | ||||
| ORR (CR/CRu/PR) | 3 (42.9) | 3 (100.0) | 5 (83.3) | 3 (100.0) | 14 (73.7) |
| 95% CI | 48.8-90.9 | ||||
| End of treatment | |||||
| CR | 3 (42.9) | 3 (100.0) | 2 (33.3) | 3 (100.0) | 11 (57.9) |
| PR | 0 | 0 | 1 (16.7) | 0 | 1 (5.3) |
| SD | 0 | 0 | 0 | 0 | 0 |
| PD | 2 (28.6) | 0 | 2 (33.3) | 0 | 4 (21.1) |
| Not evaluated | 2 (28.6) | 0 | 1 (16.7) | 0 | 3 (15.8) |
| CRR (CR/CRu) | 3 (42.9) | 3 (100.0) | 2 (33.3) | 3 (100.0) | 11 (57.9) |
| 95% CI | 33.5-79.7 | ||||
| ORR (CR/CRu/PR) | 3 (42.9) | 3 (100.0) | 3 (50.0) | 3 (100.0) | 12 (63.2) |
| 95% CI | 38.4-83.7 | ||||
Response-evaluable patients were those who received ≥1 dose of study treatment and had baseline and ≥1 posttreatment tumor assessment. Patients with missing assessments were considered nonresponders.
PD, progressive disease; SD, stable disease.