A randomized placebo-controlled phase II study of clarithromycin or placebo combined with VCD induction therapy prior to high-dose melphalan with stem cell support in patients with newly diagnosed multiple myeloma

Table 2 Clinical outcomes

		Clarithromycin group (N = 27)	Placebo group (N = 31)	P_{clarithromycin} − P_control
Clinical outcomes
VGPR or better response after VCD induction	No. (%, 95% CI)	12 (44.4%, 25.5–64.7%)	16 (51.6%, 33.1–69.8%)^a	− 7.2% (− 30.7–17.6%)^c
VGPR or better response after HDT	No. (%, 95% CI)	16 (59.3%, 38.8–77.6%)	23 (74.2%, 55.4–88.1%)^a	− 14.9% (− 37.1–8.9%)^c
Leukapheresis	10⁶/kg (range)	8 (2–20)	8.5 (2–18)^b	–
Any infection	No. (%, 95% CI)	16 (59.3%, 38.8–77.6%)	18 (58.1%, 39.1–75.5%)^a	1.2% (− 23.0–24.9%)^c

VGPR very good partial response, HDT high-dose melphalan with hematopoietic stem cell support
^aNot significant (Fisher’s exact test)
^bNot significant (Mann–Whitney test)
^cP_{clarithromycin} − P_control For response negative numbers indicate lower response in clarithromycin group. For infection positive number indicates higher risk of infection in clarithromycin group

ISSN: 2162-3619