The current paper reports on the predicting factors associated with satisfactory peripheral blood stem cell collection and the efficacy of large-volume leukapheresis (LVL) using femoral vein catheterization to harvest PBSCs with Fenwal CS 3000 Plus from normal healthy donors for allogeneic transplantation. A total of 113 apheresis procedures in 57 patients were performed. The median number of MNCs, CD3+ cells, and CD34+ cells harvested per apheresis was 5.3 x 10(8)/kg (range, 0.3-11.0 x 10(8)/kg), 3.0 x 10(8)/kg (range, 0.2-6.6 x 10(8)/kg), and 7.9 x 10(6)/kg (range, 0.1-188.9 x 10(6)/kg), respectively. The median collection efficiency of MNCs and CD34+ cells was 49.8% and 49.7%, respectively. A highly significant correlation was found between the collected CD34+ cell counts and the pre-apheresis WBC counts in the donors (P = 0.013), and between the collected CD34+ cell counts and the pre-apheresis peripheral blood (PB) CD34+ cell counts (P<0.001). Harvesting at least >4 x 10(6)/kg CD34+ cells from the 1st LVL was achieved in 44 (77.2%) out of 57 donors and in 19 (90.5%) out of 21 donors with a PB-CD34+ cell count of >40/microl. There was no significant difference in the harvested MNC and CD34+ cell counts between the 1st and 2nd apheresis. The catheter-related complications included catheter obstruction (n = 2) and hematoma at the insertion site (n = 3). Accordingly, LVL using femoral venous access for allogeneic PBSC collection from normal healthy donors would appear to be safe and effective.

BACKGROUND Standard allogeneic bone marrow transplantation (BMT) offers only a small chance of cure for most adult patients with advanced hematologic malignancies. The authors postulated that allogeneic peripheral blood stem cell transplantation (PBSCT) followed by prophylactic growth factor‐primed donor lymphocyte infusion (DLI) with cells reserved at harvest would maximize the graft‐versus‐tumor effects in patients with hematologic malignancies who had a high risk of recurrence. METHODS Seventeen patients with hematologic malignancies who had a high risk of recurrence were allocated on an intent‐to‐treat basis to allogeneic PBSCT from human leukocyte antigen‐matched sibling donors followed by prophylactic growth factor‐primed DLI of cells reserved at harvest for transplantation. RESULTS The median age was 37 years (range, 19–56 years). All donors underwent two or more apheresis procedures. The median numbers of mononuclear cells (MNCs), CD34 positive (CD34+) cells, and CD3+ cells, respectively, that were collected for 17 donors were 9.0 × 108 MNCs/kg (range, 4.9–14.4 × 108 MNCs/kg), 13.0 × 106 CD34+ cells/kg (range, 2.4–75.2 × 106 CD34+ cells/kg), and 5.8 × 108 CD3+ cells/kg (range, 3.3–9.9 × 108 CD3+ cells/kg) for a mean number of 2.35 apheresis procedures (range, 2.0–4.0 procedures). The median numbers of MNCs and CD3+ cells that were cryopreserved were 2.1 × 108 MNCs/kg (range, 0.0–4.4 × 108 MNCs/kg) and 1.4 × 108 CD3+ cells/kg (range, 0.0–3.5 × 108 CD3+ cells/kg). Seven of 17 patients received additional PBSCs, with a median of 5.0 × 107 CD3+ cells/kg (range, 3.0–9.9 CD3+ cells/kg) between Day 41 and Day 120. The reasons for inability to administer additional PBSCs in 10 patients included early death (n = 4 patients), severe graft‐versus‐host disease (GVHD) (n = 3 patients), disease recurrence (n = 2 patients), and harvest failure (n = 1 patient). Of seven patients, two patients died of recurrence, and one died of cytomegalovirus pneumonitis. The surviving four patients were free of disease when last assessed (median follow‐up, 597 days) but were suffering from chronic GVHD (one patient had limited GVHD, and three patients had extensive GVHD). CONCLUSIONS The authors suggest that allogeneic PBSCT with prophylactic growth factor‐primed DLI may be a potentially curative strategy for the treatment of hematologic malignancies in patients with a high risk of recurrence. Their approach may offer the additional advantage of collecting enough cells at harvest for the potential use of DLI, which is easy, convenient for donors, and cost effective. Cancer 2002;94:18–24. © 2002 American Cancer Society.

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BACKGROUND: Recent studies demonstrates that the combination of bortezomib and several chemotherapeutic agents may have significant activity in myeloma. In this study, we assessed the efficacy and safety of the combination with bortezomib, cyclophosphamide, thalidomide, and dexamethasone (vel-CTD) for the patients with relapsed/refractory myeloma. METHODS: Fifty-three patients who had received at least four cycles of treatment were enrolled. Bortezomib was given at 1.3 mg/m2 on D1, 4, 8, 11, thalidomide 50 mg/day, daily, cyclophosphamide 150 mg/m2 P.O. on D1–4, and dexamethasone 20 mg/m2 I.V. or P.O. on D1, 4, 8, 11. RESULTS: There were 26 males (49.1%) and 27 females (50.9%). The median age of patients was 67 years (range, 40–78 years). Median number of the previous treatment regimens was two (range, 1~5). Of total 53 patients, forty-nine patients (92.5%) achieved at least a partial response (PR) including 28 (52.8%) with complete response (CR) and 21 (42.9%) with PR as their best response. Median progression-free survival (PFS) was 14.7 months (range; 12.3–17.1 months) and median overall survival (OS), from the onset of vel-CTD was 31.6 months (range; 23.3–39.9 months). Patients who achieved a good response at least a PR after four cycles of vel-CTD showed longer PFS than those with poor therapeutic responses (2yr PFS, 28±8.7% vs. 0%, p=0.03). Further, patients who achieved a good therapeutic responses also showed significantly longer OS than those with poor responses (2yr OS, 72.3±8.3% vs. 33.3±15.7%, p=0.009). Grade 3–4 toxicities included thrombocytopenia (30.2%), neutropenia (11.3%), peripheral sensory neuropathy (32.1%), and thrombosis (3.8%). There was no treatment-related death. CONCLUSIONS: Vel-CTD is a highly active salvage therapy in patients with relapsed/refractory myeloma. However, frequent side effects such as peripheral neuropathy should be considered. Furthermore, trials evaluating novel treatment approaches after bortezomib should be offered to reduce the rate of disease progression, particularly in patients who fail to show a good response at least PR after four cycles of therapy.