Table 2.

Trials with romiplostim in combination with hypomethylating agents and lenalidomide for MDS

Trial	Greenburg et al46		Kantarjian et al45			Lyons et al47
Description	Romiplostim with Decitabine		Romiplostim with Azacitidine			Romiplostim with Lenalidomide
Treatment	Placebo	Romiplostim 750mcg	Placebo	Romiplostim		Placebo	Romiplostim
				500mcg	750mcg		500mcg	750mcg
IPSS Risk Category	Low, Intermediate-1, or 2 Risk		Low, Intermediate-1, or 2 Risk			Low or Intermediate-1 Risk
No. Patients/Cohort	14	15	13	13	14	12	14	13
Incidence of CST events (%)	79	80	85	62	71	67	29	54
Incidence of Plt. Tx (%)	57	47	69	46	36	25	7	31
Overall MDS Response (%)	36	47	NR	NR	NR	8	36	25
No. Transform to AML	1	1	0	1	0	0	1	0
Incidence of Bleeding Events (%)	43	24	2†	1†	0†	NR	NR	NR
Serious Adverse Events (%)	57	53	77	46	71`	55	39	31
No. Deaths	2	2*	2	0	0	0	0	0

^*Deaths not attributed to romiplostim group

^†Grade 3 and above bleeding events

CST: Clinically significant thrombocytopenia; AML: Acute Myelogenous Leukemia; Plt. Tx: platelet transfusions;