Table 4.
Select ongoing clinical trials.
| Type of therapy | Clinical trial and design | Number of patients | Ref. |
|---|---|---|---|
| Celoxicib versus Placebo | Phase II, double-blind, randomized controlled trial Aim: to test if celoxicib reduces the M-protein concentration |
36 monoclonal gammopathy of undermined significance and SMM | Baz 2004-ongoing |
| Lenalidomide versus Observation | Open-label, randomized controlled trial Aim: to evaluate if lenalidomide extends TTP |
370 ‘High Risk’ SMM | Lonial 2010-ongoing |
| Anti-KIR monoclonal antibody | Phase II, open-label, single-arm trial Aim: to evaluate if anti-KIR reduces the M-protein concentration ≥ 50% from Baseline | 21 SMM | Landgren 2010-ongoing |
| BHQ880, a fully human, anti-Dickkopf1 (DKK1) Neutralizing Antibody | Phase II, open-label, single-arm trial Aim: to evaluate the overall response rate |
58 ‘High Risk’ SMM | Novartis Pharmaceuticals 2011-ongoing |
| Elotuzumab (humanized anti-CS1 monoclonal lgG1 antibody) | Phase II, non-randomized, open-label trial Aim: to assess the association between NK cell status and efficacy |
40 ‘high risk’ SMM | BMS pharmaceuticals 2012-ongoing |
| Siltuximab (Anti IL 6 Monoclona Antibody) | Phase II, randomized multicenter blinded, placebo-controlled Trial Aim: 1-year progression-free survival rate |
100 ‘High Risk’ SMM | Janssen pharmaceuticals 2012-ongoing |
| Carfilzomib, Lenalidomide, and DEX | Pilot (Phase II) single-arm trial Aim: to evaluate overall response rate |
12 pilot + 18 expansion cohort (n = 30) ‘High Risk’ SMM | Landgren 2012-ongoing |
| Fenofibrate | Phase II, open-label trial Aim: to determine response rate to fenofibrate therapy |
30 | Pereira 2013-ongoing |
| PVX-410, a multi-peptide cancer vaccine | Open-label, non-randomized A Phase I/IIa dose escalation study of PVX-410, a multi-peptide cancer vaccine, in patients with SMM Aim: to determine safety and tolerability of PVX-410 |
22 SMM | Raje, Wang, & Nooka 2012-ongoing |
| BI-505 (human antibody binding to ICAM-1 [CD54]) | Phase II, single-arm, open-label trial Aim: to investigate the effect of BI-505 on tumor burden |
10 | BioInvent International AB Hansson 2013-ongoing |
| Daratumumab (anti-CD38) | Phase II, randomized, open-label trial Aim: to evaluate three Daratumumab dosing schedules in SMM |
120 SMM | Janssen Research & Development 2014-ongoing |
| Elotuzumab and Lenalidomide ± Dexamethasone (Elo/Len/Dex vs Elo/Len) | Phase II, randomized, open-label trial Aim: to evaluate proportion of patients who are progression free at 2 years; time from therapy to progression |
82 High Risk SMM | Ghobrial 2014-ongoing |
| Low-dose Bortezomib | Phase II, single-arm, open-label trial Aim: to evaluate the bone anabolic effect of Bortezomib in SMM and effect of Bortezomib on natural history of smoldering myeloma |
17 SMM | Zangari 2009-ongoing |
| IPH2101, a human monoclonal anti-KIR antibody | Phase II, randomized multicenter, open-label trial Aim: to study the anti-tumor activity, safety, and pharmacology of two dose regimens in patients with SMM |
30 SMM | Munshi 2010-2013 (completed) |
| Lenalidomide and Dexamethasone versus Observation | Phase III, randomized, open-label trial Aim: to evaluate when Len and Dex treatment extend time to progression to symptomatic multiple myeloma |
120 high risk SMM | PETHEMA Foundation 2007-2013 (completed) |
| Polyphenon E, an extract of green tea | Phase II, single-arm, open-label trial Aim: sustained M-protein reduction of > 25% from baseline |
8 monoclonal gammopathy of undermined significance and SMM | Zonder 2009-ongoing |
BMS: Bristol-Myers squibb; SMM: Smoldering multiple myeloma; ZLD: Zoledronate