Abstract
Total Therapy II (TT2), consisting of intensive induction with non-cross resistant VAD, DCEP, CAD (with collection of PBSC) and DCEP.; followed by tandem autotransplants in support of melphalan 200mg/m2; followed by consolidation chemotherapy every 3 months x4 ; followed by interferon maintenance, has complete accrual of 668 patients with upfront randomization to +/− Thalidomide. Collection goal was 20 million CD34+ cells/kg with CAD. This number allows for tandem transplants with support of >5 x 106 CD34 cells/kg, additional cells were stored in case of engraftment problems, additional transplants in the future for relapsed disease and in case of development of MDS. Patient characteristics are outlined in Table 1. 319 patients collected >20 x106 CD 34+ cells/kg with CAD (median 24.9 million, range 20–127), 2 proceeded to second collection with DCEP (median 5.005 million, range 0–10.01. Of this group 310 patients (97%) underwent single and 234 (73%) tandem autotransplant. 135 patients collected 10 – 20 x106 CD 34+ cells/kg with CAD (median 16.35 million, range 10.09–19.93), 13 patients had second collection with DCEP (median 4.92 million, range 1.23–11.68), 5 patients underwent third collection with growth factor (median 2.61million, range 0.12–12.85). Of this group 130 patients (96%) underwent single and 94 (70%) tandem autotransplant. 46 patients collected 5 – 10 x106 CD 34+ cells/kg with CAD (median 7.82 million, range 5.1–9.97), 20 patients had second collection with DCEP (median 9.785 million, range 0.93–27.14), 8 patients underwent third collection with growth factor (median 2.02million, range 0.3–11.8). No patient underwent a fourth collection attempt. Of this group 44 patients (96%) underwent single and 29 (63%) tandem autotransplant. 63 patients collected <5 x106 CD 34+ cells/kg with CAD (median 3.03 million, range 0.01–4.83), 52 patients had second collection with DCEP (median 3.49 million, range 0–21.21), 28 patients underwent third collection with growth factor (median 1.75million, range 0.07–18.99) and 8 patients had a fourth collection attempt with growth factor (median 1.35 million, range 0.22–5.5). Of this group 59 patients (94%) underwent single and 40 (63%) tandem autotransplant. 40 patients collected no CD34+ cells/kg with CAD. 17 patients had second collection with DCEP (median 11.75 million, range 019–36.36), 8 patients underwent third collection with growth factor (median 4.53 million, range 0.11–18.55) and 4 patients had a fourth collection attempt with growth factor (median 2.09 million, range 1.54–12.27). Of this group 25 patients (63%) underwent single and 4 (10%) tandem autotransplant. 53% of patients reached the collection goal with CAD alone. Using additional collection attempts we were able to increase that number to 57% of patients. In the group of the CAD non-collectors additional collection attempts yielded results up to 36 x 106 CD34+ Cells/kg allowing the majority of these patients (> 70%) to proceed to autologous transplant.
Table 1: Patients depending on initial collection result with CAD
. | Overall . | >20* . | 10–20* . | 5–10* . | 0–5* . | 0* . |
---|---|---|---|---|---|---|
* (x 106 CD34+ cells collected) | ||||||
N | 603 | 319 (53%) | 135 (22%) | 46 (8%) | 63 (10%) | 40 (9% |
Age >65 | 19% | 14% | 17% | 30% | 30% | 28% |
CA | 31% | 30% | 33% | 30% | 40% | 25% |
Thal Arm | 49% | 41% | 56% | 63% | 57% | 50% |
CRP >4 | 8% | 7% | 10% | 7% | 8% | 10% |
B2M >4 | 31% | 26% | 36% | 33% | 37% | 43% |
LDH >190 | 29% | 27% | 33% | 26% | 30% | 40% |
BM >30% PC | 64% | 62% | 67% | 63% | 67% | 60% |
. | Overall . | >20* . | 10–20* . | 5–10* . | 0–5* . | 0* . |
---|---|---|---|---|---|---|
* (x 106 CD34+ cells collected) | ||||||
N | 603 | 319 (53%) | 135 (22%) | 46 (8%) | 63 (10%) | 40 (9% |
Age >65 | 19% | 14% | 17% | 30% | 30% | 28% |
CA | 31% | 30% | 33% | 30% | 40% | 25% |
Thal Arm | 49% | 41% | 56% | 63% | 57% | 50% |
CRP >4 | 8% | 7% | 10% | 7% | 8% | 10% |
B2M >4 | 31% | 26% | 36% | 33% | 37% | 43% |
LDH >190 | 29% | 27% | 33% | 26% | 30% | 40% |
BM >30% PC | 64% | 62% | 67% | 63% | 67% | 60% |
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