Practical Approaches to the Use of Lenalidomide in Multiple Myeloma: A Canadian Consensus

Table 9

Summary of phase III trials evaluating new indications for lenalidomide in the treatment of multiple myeloma.

New indications	Trials	Regimens	Response rate	PFS	OS
	ECOG E4A03; Rajkumar et al., 2010 [30]	Len + HD dex; Len + LD dex	79%; 68%	19.1 mos; 25.3 mos	75% (2-yr); 87% (2-yr)
	MM-015 Palumbo et al. 2012 [31]; 𝑁=348 (Age 65–75)	MP	47%	12 mos	65% (3 yrs)
		MPR		15 mos	~70% (3 yrs)
		MPR-R	79%	31 mos	73% (3 yrs)
Induction therapy	MM-020	MPT; Len + LD dex until progression; Len + LD dex for 18 mos	In progress	In progress	In progress
	Palumbo et al., 2011 [32]; 𝑁=402	Len + LD dex × 4 cycles→MPR	20%	54% (2 yrs)	87% (2 yrs)
		Len + LD dex × 4 cycles→ASCT × 2	25%	73% (2 yrs)	90% (2 yrs)
Maintenance therapy after ASCT	IFM2005-02; Attal et al. 2010 [33]; 𝑁=614	Len; Placebo	—; —	42 mos; 24 mos	81% (3 yrs); 81% (3 yrs)
	CALGB 100104; McCarthy et al. 2010 [34]; 𝑁=568	Len; Placebo	—; —	43.6 mos; 21.5 mos	~80% (3 yrs); ~80% (3 yrs)
Induction and maintenance ± ASCT in newly diagnosed patients	IFM/Dana Farber trial	VRD × 8→Len maintenance × 1 yr (ASCT at progression); VRD × 3 →ASCT→Len maintenance × 1 yr	In progress	In progress	In progress

CR: compete response; PFS: progression-free survival; OS: overall survival; Len: lenalidomide; HD dex: high-dose dexamethasone; LD dex: low-dose dexamethasone; MP: melphalan, prednisone; MPR: melphalan, prednisone, lenalidomide; MPR-R: MPR + lenalidomide maintenance until progression; MPT: melphalan, prednisone, thalidomide; ASCT: autologous stem cell transplantation; VRD: bortezomib, lenalidomide, dexamethasone.