Table 3.

Clinical nanoparticle delivery systems in MM

Type	Phase	Study design	Results	Ref.
Non-targeted. PEGylated liposomal doxorubicin	Phase I	Advanced hematologic malignancies patients received PegLD (day 4 at 30 mg/m2) in combination with bortezomib (days 1, 4, 8, and 11 from 0.90 to 1.50 mg/m2).	Common toxicities were Grade 3 or 4. The MTD was 1.50 and 30 mg/m2 of bortezomib and PegLD, respectively. Antitumor activity was seen against multiple myeloma, 36% CR or near-CR, and another 36% PR.	Orlowski, R.Z., et al., Blood, 2005. 105(8): p. 3058-65.
	Phase III	Relapsed or refractory multiple myeloma patients received either intravenous bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 of an every-21-day cycle with PegLD 30 mg/m2 on day 4 or bortezomib alone.	TTP was significantly prolonged in the combination arm (median TTP = 9.3 months) compared with bortezomib monotherapy (median TTP = 6.5 months)	Orlowski, R.Z., et al., J Clin Oncol, 2007. 25(25): p. 3892-901.
	Phase II	Newly diagnosed multiple myeloma patients received intravenous PegLD (40 mg/m2), vincristine (2.0 mg, Day 1), and oral or intravenous dexamethasone (40 mg per day for 4 days) every 4 weeks for six or more cycles and/or for two cycles after the best response.	The most common toxicities were Grade 3. The overall response rate was 88%: 12% CR. TPP was 23.1 months, with 2-year and 3-year progression-free survival rates of 42% and 23%, respectively. The patient survival rate at 3 years was 67%.	Hussein, M.A., et al., Cancer, 2002. 95(10): p. 2160-8.

Legend: PegLD, PEGylated liposomal doxorubicin; MTD, maximum tolerated dose; CR, complete response; PR, partial response; TTP, time to progression