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PURPOSE Optimal postremission therapy remains controversial in adult patients with acute lymphoblastic leukemia (ALL). In a large multicentric trial (LALA87), we compared allogeneic bone marrow transplantation (BMT) with other postremission therapies (chemotherapy or autologous transplantation) using the result of the human leukocyte antigen (HLA) typing as a random allocation. PATIENTS AND METHODS Patient eligibility requirements were as follows: (1) inclusion in LALA87 trial, (2) complete response to induction or salvage therapy, (3) age 15 to 40 years, and (4) at least one potential sibling donor. Patients with an HLA-identical sibling were assigned to the BMT group, while patients without a sibling donor constituted the control group. Allogeneic transplantation was scheduled for patients in the BMT group; in the control group, patients were randomly allocated to receive chemotherapy or autologous transplantation. RESULTS Of 284 eligible points, 257 entered the study: 116 were allocated to the BMT group and 141 to the control group. The 5-year survival rates were not statistically significantly different between the two groups. When only patients with high-risk ALL were considered (those with [1] Philadelphia chromosome [Ph1] ALL, [2] null or undifferentiated ALL, or [3] c-ALL with either age greater than 35 years or WBC count > 30 x 10(9)/L or time to achieve complete remission > 4 weeks), overall survival (P = .03) and disease-free-survival (P = .01) were better for the BMT group compared with the control group (5-year overall survival rates, 44% v 20%; 5-year disease-free survival rates, 39% v 14%). CONCLUSION Allogeneic transplantation does not improve survival in patients with standard-risk ALL and should be recommended only for patients with adverse prognostic factors.

8014 Background: The IFM has shown that induction treatment prior to ASCT with VD is superior to VAD. The Italian group has presented impressive results regarding response rates with VTD (Cavo ASH 2009). In both studies, peripheral neuropathy (PN) was the most frequent adverse event (9% Grade 3). Methods: We conducted a randomized trial comparing four 21-day cycles of induction with VD (V 1.3 mg/m2/d on days 1,4,8,11 plus D 40 mg/d on days 1-4 and 8-11) or vTD (v 1 mg/m2/d on days 1,4,8,11 plus thalidomide 100 mg/d d1-21 plus dexamethasone same dosing as for VD). The primary objective was the CR rate after induction treatment. Secondary objectives were achievement ≥ VGPR and ≥ PR, and toxicity including incidence of PN. Results: From 03/2008 to 01/2009, 205 patients with de novo MM (< 66 years) were randomized. The two groups were well balanced as regards initial prognostic parameters. As of January 10, 2010, according to investigators'assessment, on an intent-to-treat basis, the post-induction efficacy r...

8113 Background: Translocation t(4;14)(p16;q32) has been associated with a poor outcome in multiple myeloma. This poor prognosis has been identified both in patients treated with melphalan-predniso...

8018 Background: High-dose therapy with autologous stem cell transplantation (ASCT) is a standard treatment for myeloma patients. However, a residual disease (RD) responsible for relapse is always ...

8519 Background: Clinical trial outcomes are usually published when statistical protocol objectives have been met, with short median follow-up not exceeding 5 years. Due to treatment innovations, MM survival beyond 10 years has become more common but formal long-term results are seldom reported. Methods: IFM, SWOG and ARK provide an update of their major trials. IFM-90: 1 AT v standard therapy (STD), IFM-94: 2 v 1 AT, IFM-9902: 2AT ± THAL, IFM-9904: 2AT for high-risk MM; SWOG-9321: 1 AT v STD; TT1: 2 AT with interferon, TT2: 2AT ± THAL, TT3: 2AT + THAL + bortezomib. Results: OS clustered in 3 groups with superior outcomes for TT3/TT2/IFM-99 v TT1 v IFM-94/ IFM-90/SWOG-9321 with 5/10/15-yr estimates of 70%/50%/TE v 57%/35%/20% v 43%/25%/15% (p=3.5mg/L (p=ULN (p [Table: see text]

8542 Background: Renal impairment (RI) is common among patients (pts) presenting with myeloma (MM) and requires aggressive early intervention. Two recently published phase III trials showed significant benefit after treatment with lenalidomide plus dexamethasone (Len/Dex) over Dex alone for pts with refractory or relapsing MM. Methods: In pooled data, 682 pts with serum creatinine (Cr) ≤2.5 mg/dL received treatment at a starting dose of 25 mg/day Len on days 1–21 and 40 mg/day Dex on days 1–4, 9–12, and 17–20days 1–4, every 28-day cycle. We now evaluate efficacy and safety of Len/Dex and Dex alone in the subgroup of pts who had normal (CLcr >80 mL/min), mild (50≤ CLcr

8505 Background: ASCT is the standard of care for MM patients (pts) aged ≤65 yrs with high complete plus very good partial remission (CR+VGPR) rate. Improving CR rate has been associated with prolonged PFS and OS. Phase 2 studies have shown bortezomib (VELCADE)/dexamethasone (Vel/Dex) as an effective induction therapy. Methods: In this phase 3 study, Vel/Dex (4 cycles) was compared with vincristine/doxorubicin/dexamethasone (VAD; 4 cycles) as induction prior to ASCT in 482 MM pts aged ≤65 years. Primary objective was CR+near-CR (nCR) rate. Planned enrolment (480 pts) provided 80% power to detect a 10% difference in CR+nCR rate (10% vs 20%). Consolidation with 2 cycles of Dex, cyclophosphamide, etoposide, platinum (DCEP) was also evaluated. Pts were randomized to 4 arms: A1: VAD (N=121), A2: VAD+DCEP (N=121), B1: Vel/Dex (N=121), and B2: Vel/Dex+DCEP (N=119). Results: In the intent-to-treat analysis (ITT) Vel/Dex had significantly higher CR+nCR/≥VGPR vs VAD post-induction (21.3%/46.7% vs 8.3%/18.6%, P=0.00...

6653 Background: Standard induction therapy for patients (pts) with newly diagnosed Multiple Myeloma (MM) is based on Dexamethasone (Dex). Currently, the use of VAD or Dex alone results in a complete remission (CR) rate of < 10%. Both in vitro studies and preliminary clinical experience have suggested that bortezomib and Dex could be synergistic. Methods: The IFM group initiated a Phase II open trial evaluating the combination of bortezomib and Dex in pts with previously untreated MM and candidates for ASCT. The regimen consisted of bortezomib 1.3mg/m2 iv on days 1, 4, 8, 11 and Dex 40 mg per os days 1–4, 9–12 (for the first 2 cycles, days 1–4 only for the last 2 cycles), administered on 4 consecutive 21 days cycles. Stem cell collection was performed just before cycle 4 after G-CSF priming. The primary objective of the study was CR rate after 4 cycles. 53 pts have been recruited and data are available for the first 36 pts. The median age is 54 years (38–71). Toxicity: Twenty seven/36 (75%) pts received t...