Table 3.
Randomized studies done in post-ASCT maintenance therapy.
| Study | Induction Therapy | Drug and Dosage of Maintenance | Duration of Maintenance | PFS/EFS (Maintenance vs. Observation) |
OS (Maintenance vs. Observation) |
|---|---|---|---|---|---|
| GIMEMA RV-209 [53] | 4 cycles of Rd followed by either tandem ASCT(Mel200) or MPR | Len 10 mg (3 weeks on, 1 week off) | Until progression | Cumulative median PFS: 42 vs. 22 mo (p < 0.001) | 3-yr OS: 88% vs. 79% (p = 0.14) |
| MRC IX [78] | Up to 6 cycles of CTD or CVAD | Thal 50 mg daily for 4 weeks, increased to 100 mg daily if tolerated | Until progression | Median PFS: 22 mo vs. 15 mo (p < 0.0001) | Median OS: 60 mo in both arms (p = 0.70) |
| IFM 2005-02 [79] | VAD, Bort/dex Induction intensification with DCEP in 25% |
Len 10 mg continuous, can increase to 15 mg preceded by Consolidation with Len 25 mg 3 out of 4 weeks for 2 cycles |
Discontinued at a median time of 2 yr (range 1-3 yr) due to concerns about SPMs | Median PFS: 46 mo vs. 24 mo (p < 0.001) | At a median follow-up of 77 mo: 82 mo vs. 81 mo (p = 0.8) |
| CALGB 100104 [80] | Len, Thal, and/or Bort containing regimen | Len 10 mg continuous, increased to 15 mg after 3 months | Until progression or toxicity | Median PFS: 57.3 mo vs. 28.9 mo (p < 0.001) | 5-yr OS: 76% vs. 64% (p < 0.0004) |
| MRC XI [28] | 4 cycles of CTD or CRD or KCRD. Consolidation with VCD for < VGPR prior to ASCT if induction was CTD or CRD | Len 10 mg (3 weeks on, 1 week off) vs. obs | Until progression | After median f/u of 31 mo, Median PFS: 39 mo vs. 20 mo (p < 0.0001) | 5-yr OS: 61.3% vs. 56.6% (p = 0.15) |
| TOURMALINE-MM3 [84] | Ixa 3 mg on d 1, 8, 15 out of 28 days (4 mg from cycle 5 if 3mg was tolerated) vs. placebo | 2 yrs | Median PFS: 26.5 mo vs. 21.3 mo (p = 0.0023) | NR | |
| NCT02253316 [85] | With PI+ IMiD in 85%, PI based (without IMiD) in 14% | Ixa 4 mg (d 1, 8, 15 out of 28-days) vs. Len 10 mg (daily for 3 mo) followed by 15 mg (daily from 4 mo onwards) | Until progression | 30% on Ixa arm and 12% on Len arm progressed at a median f/u of 11.2 and 12.3 mo respectively | NR |
| FORTE (NCT03224507) [86] | KCdx4→ASCT→KCdx4 KRdx4→ASCT→KRdx4 KCd→stem cell collection→KRdx8 |
Len vs. Len +Car | Until progression | Ongoing | Ongoing |