Ongoing phase 2 and 3 trials for treatment of SMM
| Trial . | Phase . | Intervention . | Control arm . | Outcome . |
|---|---|---|---|---|
| NCT03839459 | 2 | Denosumab monthly every 4 weeks for 12 cycles | No | Proportion of patients with a downgraded risk of progression of smoldering multiple myeloma |
| NCT02916771 | 2 | Ixazomib, lenalidomide, and dexamethasone for 9 cycles, followed by ixazomib and lenalidomide for 15 cycles | No | PFS at 2 years |
| NCT03301220 (AQUILA) | 3 (randomized) | Daratumumab subcutaneously for 39 cycles or until progression or unacceptable toxicity | Observation | PFS |
| NCT03815279 (iStopMM) | 2 | High-risk SMM: carfilzomib, lenalidomide, and dexamethasone for 24 cycles Intermediate-risk SMM: lenalidomide and dexamethasone for 24 cycles | No | MRD negativity at 36 months |
| NCT02279394 | 2 | Elotuzumab, lenalidomide, and dexamethasone for 8 cycles followed by elotzumab and lenalidomide for cycles 9 to 24 | No | PFS at 2 years |
| NCT03236428 | 2 | Daratumumab subcutaneously for 20 cycles (only including low-risk SMM) | No | Proportion of patients in VGPR or better after 20 cycles |
| NCT05014646 | 2 | Leflunomide daily until disease progression or unacceptable toxicity | No | PFS at 2 years and incidence of adverse effects |
| NCT05469893 (Immuno-PRISM) | 2 (randomized) | Teclistamab for 24 months | Lenalidomide and dexamethasone for 24 months | CRR |
| NCT03289299 (ASCENT) | 2 | Daratumumab, lenalidomide, and dexamethasone for 12 cycles followed by daratumumab and lenalidomide for 12 cycles | No | sCR rate |
| NCT04776395 | 2 (randomized) | Iberdomide and dexamethasone for 4 cycles followed by iberdomide until progression or unacceptable toxicity | Iberdomide until disease progression or unacceptable toxicity | ORR |
| NCT04775550 (B-PRISM) | 2 | Daratumumab, bortezomib, lenalidomide, and dexamethasone up to 24 months | No | MRD negativity at 2 years |
| NCT04850846 | 2 | Metformin for 6-12 months (only including low-risk SMM) | Placebo | M-protein concentrations/light chains change from baseline to 6 months |
| NCT03937635 (DETER-SMM) | 3 (randomized) | Daratumumab, lenalidomide, and dexamethasone up to cycles, progression, or unacceptable toxicity | Lenalidomide and dexamethasone until progression or unacceptable toxicity | OS and Functional Assessment of Cancer Therapy–General score |
| NCT03673826 (HO147SMM) | 2 (randomized) | Carfilzomib, lenalidomide, and dexamethasone for 9 cycles followed by lenalidomide up for 24 cycles | Lenalidomide and dexamethasone for 9 cycles followed by lenalidomide up for 24 cycles | PFS |
| NCT04731844 | 2 | Curcumin plus Piperine orally for 12 months (only including low-risk SMM) | No | Response rate from baseline to 12 months |
| NCT04270409 (ITHACA) | 3 (randomized) | Isatuximab, lenalidomide, and dexamethasone for 36 months | Lenalidomide and dexamethasone for 36 months | PFS |
| NCT03792763 | 2 (randomized) | Denosumab every 4 weeks for 6 months, then every 3 months for 3 years | Placebo | Time to progression |
| Trial . | Phase . | Intervention . | Control arm . | Outcome . |
|---|---|---|---|---|
| NCT03839459 | 2 | Denosumab monthly every 4 weeks for 12 cycles | No | Proportion of patients with a downgraded risk of progression of smoldering multiple myeloma |
| NCT02916771 | 2 | Ixazomib, lenalidomide, and dexamethasone for 9 cycles, followed by ixazomib and lenalidomide for 15 cycles | No | PFS at 2 years |
| NCT03301220 (AQUILA) | 3 (randomized) | Daratumumab subcutaneously for 39 cycles or until progression or unacceptable toxicity | Observation | PFS |
| NCT03815279 (iStopMM) | 2 | High-risk SMM: carfilzomib, lenalidomide, and dexamethasone for 24 cycles Intermediate-risk SMM: lenalidomide and dexamethasone for 24 cycles | No | MRD negativity at 36 months |
| NCT02279394 | 2 | Elotuzumab, lenalidomide, and dexamethasone for 8 cycles followed by elotzumab and lenalidomide for cycles 9 to 24 | No | PFS at 2 years |
| NCT03236428 | 2 | Daratumumab subcutaneously for 20 cycles (only including low-risk SMM) | No | Proportion of patients in VGPR or better after 20 cycles |
| NCT05014646 | 2 | Leflunomide daily until disease progression or unacceptable toxicity | No | PFS at 2 years and incidence of adverse effects |
| NCT05469893 (Immuno-PRISM) | 2 (randomized) | Teclistamab for 24 months | Lenalidomide and dexamethasone for 24 months | CRR |
| NCT03289299 (ASCENT) | 2 | Daratumumab, lenalidomide, and dexamethasone for 12 cycles followed by daratumumab and lenalidomide for 12 cycles | No | sCR rate |
| NCT04776395 | 2 (randomized) | Iberdomide and dexamethasone for 4 cycles followed by iberdomide until progression or unacceptable toxicity | Iberdomide until disease progression or unacceptable toxicity | ORR |
| NCT04775550 (B-PRISM) | 2 | Daratumumab, bortezomib, lenalidomide, and dexamethasone up to 24 months | No | MRD negativity at 2 years |
| NCT04850846 | 2 | Metformin for 6-12 months (only including low-risk SMM) | Placebo | M-protein concentrations/light chains change from baseline to 6 months |
| NCT03937635 (DETER-SMM) | 3 (randomized) | Daratumumab, lenalidomide, and dexamethasone up to cycles, progression, or unacceptable toxicity | Lenalidomide and dexamethasone until progression or unacceptable toxicity | OS and Functional Assessment of Cancer Therapy–General score |
| NCT03673826 (HO147SMM) | 2 (randomized) | Carfilzomib, lenalidomide, and dexamethasone for 9 cycles followed by lenalidomide up for 24 cycles | Lenalidomide and dexamethasone for 9 cycles followed by lenalidomide up for 24 cycles | PFS |
| NCT04731844 | 2 | Curcumin plus Piperine orally for 12 months (only including low-risk SMM) | No | Response rate from baseline to 12 months |
| NCT04270409 (ITHACA) | 3 (randomized) | Isatuximab, lenalidomide, and dexamethasone for 36 months | Lenalidomide and dexamethasone for 36 months | PFS |
| NCT03792763 | 2 (randomized) | Denosumab every 4 weeks for 6 months, then every 3 months for 3 years | Placebo | Time to progression |
CRR, complete response rate; sCR, stringent complete response; VGPR, very good partial response.