Table 6.

Overview of selected clinical trials for SMM patients

ClinicalTrials.gov Identifier	Trial design	Interventional drug	Primary outcomes
NCT02279394	Phase II	Elotuzumab, lenalidomide, dexamethasone	TTP at 2 years
NCT02903381	Phase II	Nivolumab, lenalidomide dexamethasone	TTP at 2 years
NCT02916771	Phase II	Ixazomib, lenalidomide, dexamethasone	2-years PFS rate
NCT02603887	Phase I	Pembrolizumab	ORR
NCT02415413	Phase II	Carfilzomib, lenalidomide, dexamethasone	Efficacy by Flow-CR at day 100 post ASCT
NCT01484275	Phase II	Siltuximab	1-year PFS rate
NCT02943473	Phase II	Ibrutinib	TTP at 1 year
NCT01718899	Phase I/IIa	PVX-410, a multi-peptide cancer vaccine	Safety and toxicity
NCT02784483	Phase I	Atezolizumab (anti-PD-L1)	Prevalence of anti-SOX2 reactive T-cells after anti-PDL1 therapy
NCT03236428	Phase I	Daratumumab	Proportion of patients in deep response at 2-year time
NCT02697383	Phase I	Ixazomib, dexamethasone	ORR at 1 year
NCT02886065	Phase Ib	PVX-410 (a multi-peptide cancer vaccine), durvalumab, +/− lenalidomide	Safety and toxicity
NCT02960555	Phase II	Isatuximab	ORR at 6 months
NCT02492750	Phase I/II	Anakinra, lenalidomide dexamethasone	Safety and toxicity, MTD, TTP at 2 years
NCT02240537	Phase I	BBMPI03, an oncofetal antigen multi-peptide immunotherapy	Safety and tolerability, DLT, MTD, and OBD

Note: Data from Muchtar et al⁶² and Mateos et al⁶³.

Abbreviations: ASCT, autologous stem cell transplantation; DLT, dose-limiting toxicity; MTD, maximum tolerated dose; OBD, optimal biologic dose; ORR, objective response rate; PFS, progression-free survival; SMM, smoldering multiple myeloma; TPP, time-to-progression.