Prospective Comparative Study of Etoposide plus G-CSF versus G-CSF Alone, Followed by Risk-Adapted Plerixafor for Peripheral Blood Stem Cell Mobilization in Patients with Newly Diagnosed Multiple Myeloma: CAtholic REsearch Network for Multiple Myeloma Study (CAREMM-2001)

SIMPLE SUMMARY: We conducted a prospective trial comparing single-dose etoposide (375 mg/m(2) for one day) plus G-CSF versus G-CSF alone, followed by risk-adapted plerixafor in myeloma patients. Despite significantly less frequent (p = 0.045) use of plerixafor in the etoposide group, the optimal collection rates (CD34+ cells ≥ 6 × 10(6)/kg) were not significantly different between the two groups (p = 0.195). In addition, the rate of collected CD34+ cells of ≥ 8.0 × 10(6)/kg was significantly higher in the etoposide group. Our results suggest that single-dose etoposide plus G-CSF may be a better option for patients who are expected to receive two or more transplantations. ABSTRACT: To explore the optimal mobilization for multiple myeloma (MM) patients, we conducted a prospective trial comparing single-dose etoposide (375 mg/m(2) for one day) plus G-CSF versus G-CSF alone, followed by risk-adapted plerixafor. After randomization, 27 patients in the etoposide group and 29 patients in the G-CSF alone group received mobilizations. Six (22.2%) patients in the etoposide group and 15 (51.7%) patients in the G-CSF alone group received plerixafor based on a peripheral blood CD34+ cell count of < 15/mm(3) (p = 0.045). The median count of CD34+ cells collected was significantly higher in the etoposide group (9.5 × 10(6)/kg vs. 7.9 × 10(6)/kg; p = 0.018), but the optimal collection rate (CD34+ cells ≥ 6 × 10(6)/kg) was not significantly different between the two groups (96.3% vs. 82.8%; p = 0.195). The rate of CD34+ cells collected of ≥ 8.0 × 10(6)/kg was significantly higher in the etoposide group (77.8% vs. 44.8%; p = 0.025). Although the rates of grade II–IV thrombocytopenia (63.0% vs. 31.0%; p = 0.031) and grade I–IV nausea (14.8% vs. 0%; p = 0.048) were significantly higher in the etoposide group, the rates of adverse events were low in both groups, with no neutropenic fever or septic shock. Thus, both single-dose etoposide plus G-CSF and G-CSF alone with risk-adapted plerixafor were effective and safe, but the former may be the better option for patients who are expected to receive two or more transplantations.