Active or planned phase 2 and 3 studies for intermediate- and high-risk SMM
| Study (clinicaltrials.gov identifier) . | Phase . | Estimated enrollment . | Recruitment status . | Estimated study completion date . | Interventions . | Primary end point . | Preliminary efficacy data reported . |
|---|---|---|---|---|---|---|---|
| NCT04270409 | Phase 3 Randomized | 300 | Recruiting | 2033 | • Intervention arm: Isatuximab + Rd • Control arm: Rd | PFS | — |
| DETER-SMM NCT03937635 | Phase 3 Randomized | 288 | Recruiting | 2028 | • Intervention arm: DRD • Control arm: Rd • Both arms treated for up to 24 cycles (in the absence of disease progression or unacceptable toxicity) | OS and FACT- G score (quality-of-life measure) | — |
| AQUILA NCT03301220 | Phase 3 Randomized | 390 | Active, not recruiting | 2025 | • Intervention: subcutaneous daratumumab • Control: observation | PFS | — |
| NCT03850522 | Phase 2a Single arm | 20 | Recruiting | 2021 | • PD-L1 peptide vaccination subcutaneously every 2 weeks (total 26-week treatment duration) | ORR (≥PR) | — |
| NCT03839459 | Phase 2 Single arm | 20 | Recruiting | 2024 | • Subcutaneous Denosumab every 4 weeks | Reduction in SMM risk category | — |
| ASCENT NCT03289299 | Phase 2 Single arm | 83 | Recruiting | 2026 | • D-KRD × 6 cycles (induction) • D-KRD × 6 cycles (consolidation) • DR × 12 cycles (maintenance) | Stringent CR at any point during treatment | (Only safety data reported to date) |
| HO147SMM NCT03673826 | Phase 2 Randomized | 120 | Recruiting | 2025 | • Intervention arm: KRD × 9 cycles → R alone (up to 24 cycles) • Control arm: Rd × 9 cycles → R alone (up to 24 cycles) | PFS | — |
| NCT04775550 | Phase 2 Single arm | 30 | Not yet recruiting | 2026 | • D-VRD × up to 24 cycles (in absence of disease progression or toxicity) | 2-y MRD−rate | — |
| NCT04776395 | Phase 2 | 68 | Not yet recruiting | 2023 | • Arm A: Iberdomide + dexamethasone × 4 cycles (induction) → Iberdomide alone until disease progression or unacceptable toxicity • Arm B: Iberdomide alone until disease progression or unacceptable toxicity | ORR (≥PR) | — |
| E-PRISM NCT0227939442 | Phase 2 Single arm | 51 | Active, not recruiting | 2023 | • Elotuzumab + Rd × 8 cycles (induction) → Elotuzumab + R × cycles 9-24 (maintenance) | PFS | • Median follow-up not reported (n = 50) • PFS data NR • ORR 84%, CR 6% |
| NCT0291677143 | Phase 2 Single arm | 55 | Active, not recruiting | 2024 | • Ixazomib + Rd × 9 cycles (induction) → Ixazomib + R cycles 10-24 (maintenance) | PFS | • Median 8 cycles completed (n = 26) • No progression to date • ORR 89%, CR 19% |
| NCT0296055544 | Phase 2 Single arm | 61 | Active, not recruiting | 2022 | • Intervention: isatuximab IV × up to 30 cycles (in absence of disease progression or toxicity) | ORR (≥PR) | • Median 11.5 cycles completed (n = 24) • ORR 62.5% |
| GEM-CESAR NCT0241541345,46 | Phase 2 Single arm | 90 | Active, not recruiting | 2027 | • KRD × 6 cycles (induction) → melphalan conditioning and ASCT (intensification) → KRD × 2 cycles (consolidation) → Rd × 2 years (maintenance) | MRD−NGF (next generation flow) postinduction and ASCT | • Median follow-up 32 months (n = 90) • MRD−: 30% postinduction, 52% post-ASCT, 57% postconsolidation • MRD− and ≥CR: 23% postinduction, 44% post-ASCT, 55% postconsolidation |
| NCT0157248047 | Phase 1/2 Single arm | 52 | Active, not recruiting | 2025 | • Phase 1: KRD × 8 cycles (induction) → R alone for 12 cycles (maintenance) • Phase 2: KRD × 8 cycles (induction) → R alone for up to 24 cycles (maintenance) | MRD−CR (NGF, ≤10–5 sensitivity) | • Median follow-up 27.3 months (n = 52) • MRD−CR: 70.2 months |
| Study (clinicaltrials.gov identifier) . | Phase . | Estimated enrollment . | Recruitment status . | Estimated study completion date . | Interventions . | Primary end point . | Preliminary efficacy data reported . |
|---|---|---|---|---|---|---|---|
| NCT04270409 | Phase 3 Randomized | 300 | Recruiting | 2033 | • Intervention arm: Isatuximab + Rd • Control arm: Rd | PFS | — |
| DETER-SMM NCT03937635 | Phase 3 Randomized | 288 | Recruiting | 2028 | • Intervention arm: DRD • Control arm: Rd • Both arms treated for up to 24 cycles (in the absence of disease progression or unacceptable toxicity) | OS and FACT- G score (quality-of-life measure) | — |
| AQUILA NCT03301220 | Phase 3 Randomized | 390 | Active, not recruiting | 2025 | • Intervention: subcutaneous daratumumab • Control: observation | PFS | — |
| NCT03850522 | Phase 2a Single arm | 20 | Recruiting | 2021 | • PD-L1 peptide vaccination subcutaneously every 2 weeks (total 26-week treatment duration) | ORR (≥PR) | — |
| NCT03839459 | Phase 2 Single arm | 20 | Recruiting | 2024 | • Subcutaneous Denosumab every 4 weeks | Reduction in SMM risk category | — |
| ASCENT NCT03289299 | Phase 2 Single arm | 83 | Recruiting | 2026 | • D-KRD × 6 cycles (induction) • D-KRD × 6 cycles (consolidation) • DR × 12 cycles (maintenance) | Stringent CR at any point during treatment | (Only safety data reported to date) |
| HO147SMM NCT03673826 | Phase 2 Randomized | 120 | Recruiting | 2025 | • Intervention arm: KRD × 9 cycles → R alone (up to 24 cycles) • Control arm: Rd × 9 cycles → R alone (up to 24 cycles) | PFS | — |
| NCT04775550 | Phase 2 Single arm | 30 | Not yet recruiting | 2026 | • D-VRD × up to 24 cycles (in absence of disease progression or toxicity) | 2-y MRD−rate | — |
| NCT04776395 | Phase 2 | 68 | Not yet recruiting | 2023 | • Arm A: Iberdomide + dexamethasone × 4 cycles (induction) → Iberdomide alone until disease progression or unacceptable toxicity • Arm B: Iberdomide alone until disease progression or unacceptable toxicity | ORR (≥PR) | — |
| E-PRISM NCT0227939442 | Phase 2 Single arm | 51 | Active, not recruiting | 2023 | • Elotuzumab + Rd × 8 cycles (induction) → Elotuzumab + R × cycles 9-24 (maintenance) | PFS | • Median follow-up not reported (n = 50) • PFS data NR • ORR 84%, CR 6% |
| NCT0291677143 | Phase 2 Single arm | 55 | Active, not recruiting | 2024 | • Ixazomib + Rd × 9 cycles (induction) → Ixazomib + R cycles 10-24 (maintenance) | PFS | • Median 8 cycles completed (n = 26) • No progression to date • ORR 89%, CR 19% |
| NCT0296055544 | Phase 2 Single arm | 61 | Active, not recruiting | 2022 | • Intervention: isatuximab IV × up to 30 cycles (in absence of disease progression or toxicity) | ORR (≥PR) | • Median 11.5 cycles completed (n = 24) • ORR 62.5% |
| GEM-CESAR NCT0241541345,46 | Phase 2 Single arm | 90 | Active, not recruiting | 2027 | • KRD × 6 cycles (induction) → melphalan conditioning and ASCT (intensification) → KRD × 2 cycles (consolidation) → Rd × 2 years (maintenance) | MRD−NGF (next generation flow) postinduction and ASCT | • Median follow-up 32 months (n = 90) • MRD−: 30% postinduction, 52% post-ASCT, 57% postconsolidation • MRD− and ≥CR: 23% postinduction, 44% post-ASCT, 55% postconsolidation |
| NCT0157248047 | Phase 1/2 Single arm | 52 | Active, not recruiting | 2025 | • Phase 1: KRD × 8 cycles (induction) → R alone for 12 cycles (maintenance) • Phase 2: KRD × 8 cycles (induction) → R alone for up to 24 cycles (maintenance) | MRD−CR (NGF, ≤10–5 sensitivity) | • Median follow-up 27.3 months (n = 52) • MRD−CR: 70.2 months |
ASCT, autologous stem cell transplant; D-KRD, daratumumab, carfilzomib, lenalidomide, and dexamethasone; DRD, daratumumab, lenalidomide, and dexamethasone; D-VRD, daratumumab, lenalidomide, dexamethasone; FACT-G, functional assessment of cancer therapy-general; IV, intravenous; ORR, overall response rate; NGF, next generation flow; PR, partial response.