Table 2.
Summary of the most relevant clinical trials with pomalidomide in relapsed MM patients
| Phase | +/− Dex or other comb. | n | Prior lines | Dose | Schedule | ORR ≥ PR | CBR ≥ MR | PFS Months | OS Months | Reference |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | No | 24 | 3 (1–6) | MTD: 2 mg | 1–28 (daily) | 54% | 71% | 9.7 | 22.5 | Schey. JCO 2004 179 |
| 1 | No | 20 | 4 (1–7) | MTD: 5 mg | 1–28 (Every other day) | 50% | 55% | 10.5 | 33 | Streetly. BJH 2008 180 |
| 1b | Dex& | 38* | 6 (2–17) | MTD: 4 mg | 1–21 | Pom: 13% + Dex: 21% |
Pom: - + Dex: 42% |
4.6 | 18.3 | Richardson. Blood 201366 |
| 2 | No | 108* | 5 (1–13) | 4 mg | 1–21 | 15% | 31% | 2.6 | 13.6 | Richardson. ASH 2011181 & Siegel ASCO 2013182 |
| Dex | 113* | 4 mg | 1–21 | 34% | 45% | 4.6 | 16.5 | |||
| 2 | Dex | 60 | 2 (all ≤ 3) | 2 mg | 1–28 | 65% | - | 13 | 40 | Lacy. JCO 200967 & ASH 201269 |
| 2 | Dex | 34** | 4 (1–7+) | 2 mg | 1–28 | 32% | 47% | 5 | 33 | Lacy Leukemia 201068 & ASH 201269 |
| 2 | Dex | 60** | 2 (all ≤ 3) | 4 mg | 1–28 | 38% | - | 7.7 | 92%$ | Lacy ASH 201269 |
| 2 | Dex | 120** | - | 4 mg | 1–21 | 21% | - | 4.3 | 74%$ | Lacy ASH 201269 |
| 2 | Dex | 35*** | 6 (3–9) | 2 mg | 1–28 | 26% | 49% | 6.4 | 16 | Lacy Blood 201170 & ASH 201269 |
| Dex | 35*** | 6 (2–11) | 4 mg | 1–28 | 29% | 43% | 3.3 | 9.2 | ||
| 2 | Dex | 43*** | 5 (1–13) | 4 mg | 1–21 | 35% | - | 5.4 | 14.9 | Leleu Blood 201371 |
| Dex | 41*** | 4 mg | 1–28 | 34% | - | 3.7 | 14.8 | |||
| 3 | Dex | 302** | 5 (1–17) | 4 mg | 1–21 | 31% | - | 4 | NR | San Miguel ASCO 201372 |
| 2 | Clarithromycin/Dex | 100 | 5 (3–15) | 4 mg | 1–21 | 54% | 59% | 8.2 | NR | Mark ASH 2012183 |
| 1/2 | Carfilzomib/Dex | 32** | 6 (2–15)# | 4 mg | 1–21 | 33% | 56% | 70%$# | - | Shah ASH 201237 |
| 2 | PLD/Dex | 27 | 5 (1–18) | MTD: 3 mg | 1–21 | 22% | 39% | - | - | Hilger ASCO 2013184 |
| 1 | Bortezomib/Dex | 21** | 1–4 | MTD: 4 mg | 1–21 | 72% | - | - | - | Richardson ASCO 2013185 |
| 1 | Cyclophosphamide/Dex | 10** | 5 (3–10) | 4 mg | 1–21 | 40% | 50% | - | - | Baz ASH 2012186 |
| 1/2 | Cyclophosphamide/Prednisone | 55 | 3 (1–3) | MTD: 2.5 mg | - | 51% | - | 10.4 | - | Larocca Blood 2013187 |
Dex: Low Dose Dexamethasone (40 mg weekly) except for the trial with Cyclophosphamide + Dexamethasone that are high doses.
MTD: Maximum tolerated dose
PLD: Pegylated liposomal doxorubicin
*
Previous lenalidomide & bortezomib
**
Lenalidomide-refractory patients
***
Lenalidomide- & bortezomib-refractory
&
Dexamethasone added in 22 non-responding patients
$
OS/PFS at 6 months
#
Corresponds to the 12 patients enrolled in the phase 1