Table 4.
Ongoing phase 3 and randomized phase 2 comparative studies of continuous therapy and maintenance treatment approaches that have not yet reported data at the time of publication (ClinicalTrials.gov, April 26, 2019).
| Study | NCT number | Phase | Maintenance/continuous treatment regimens | N | Primary endpoint | Estimated 1° completion date |
|---|---|---|---|---|---|---|
| Post-ASCT maintenance therapy | ||||||
| GEM2014MAIN | NCT02406144 | 3 | Ixazomib-Rd vs. Rd | 316 | PFS | Not known |
| MMRC | NCT02253316 | 2 | Ixazomib vs. R | 240 | MRD | November 2019 |
| NCI-2015-00138 | NCT02389517 | 2 | Ixazomib-Rd vs. R | 86 | MRD | March 2020 |
| ATLAS | NCT02659293 | 3 | Carfilzomib-Rd vs. R | 180 | PFS | March 2019 |
| FORTE | NCT02203643 | 2 | Carfilzomib-R vs. R | 477 | ≥VGPR rate post-induction | October 2016a |
| Cassiopeia | NCT02541383 | 3 | Daratumumab vs. observation | 1085 | PFS | August 2022 |
| EMN18b | NCT03896737 | 2 | Daratumumab-ixazomib vs. ixazomib | 400 | MRD-neg rate; 2-year PFS | February 2022 |
| AURIGA/MMY3021 | NCT03901963 | 3 | Daratumumab-R vs. R | 214 | MRD-neg rate at 12 months | May 2021 |
| GRIFFIN/MMY2004 | NCT02874742 | 2 | Daratumumab-R vs. R | 222 | sCR rate post-consolidation | January 2019 |
| DraMMaticc | SWOG1803/BMT CTN 1706 | 3 | Daratumumab-R vs. R | Not known | Not known | Not known |
| GMMG-HD6 | NCT02495922 | 3 | Elotuzumab-R vs. R | 564 | PFS | June 2020 |
| GMMG-HD7 | NCT03617731 | 3 | Isatuximab-R vs. R | 662 | PFS | May 2025 |
| Continuous frontline therapy, non-ASCT setting | ||||||
| TOURMALINE-MM2 | NCT01850524 | 3 | Ixazomib-Rd vs. placebo-Rd | 701 | PFS | February 2018 |
| COBRA | NCT03729804 | 3 | Carfilzomib-Rd vs. VRd | 250 | PFS | December 2021 |
| GEM2017FIT | NCT03742297 | 3 | Daratumumab + carfilzomib-Rd vs. carfilzomib-Rd vs. VMP-Rd | 300 | CR rate | October 2020 |
| Perseus | NCT03710603 | 3 | Daratumumab-VRd–daratumumab-R vs. VRd–R | 690 | PFS | May 2029 |
| MMY3019 | NCT03652064 | 3 | Daratumumab-VRd–daratumumab-Rd vs. VRd–Rd | 360 | MRD-neg rate | March 2024 |
| ELOQUENT-1 | NCT01335399 | 3 | Elotuzumab-Rd vs. Rd | 750 | PFS | May 2019 |
| SWOG S1211 | NCT01668719 | 2 | Elotuzumab-VRd vs. VRd | 122 | PFS | May 2019 |
| IMROZ | NCT03319667 | 3 | Isatuximab-VRd–isatuximab-Rd vs. VRd–Rd | 440 | PFS | December 2022 |
| Post-induction maintenance therapy, non-ASCT setting | ||||||
| TOURMALINE-MM4 + China continuation | 3 | Ixazomib vs. placebo |
706 105 |
PFS |
August 2019 September 2024 |
|
| Myeloma XIV (FiTNEss) | NCT03720041 | 3 | Ixazomib-R vs. placebo-R (post-ixazomib-Rd) | 740 | PFS | December 2024 |
| X16108 | NCT03733691 | 2 | Ixazomib-R vs. ixazomib | 52 | PFS, AEs | December 2023 |
| AGMT_MM-2 | NCT02891811 | 2 | Carfilzomib vs. observation | 146 | Post-induction ORR | September 2023 |
AEs adverse events, ASCT autologous stem cell transplant, CR complete response, MRD-neg negative for minimal residual disease, ORR overall response rate, PFS progression-free survival, R lenalidomide, Rd lenalidomide-dexamethasone, VMP bortezomib-melphalan-prednisone, VRd bortezomib-lenalidomide-dexamethasone.
aData reported from induction/consolidation phase63; data not yet reported from the randomized maintenance phase of the study.
bIncludes information from https://www.myeloma-europe.org/trials/emn-18/.
cInformation from https://www.swog.org/clinical-trials/s1803.