Multiple Myeloma: International Myeloma Foundation : •treatment options : supportive care : ASCO 2010: Lenalidomide, bortezomib, and dexamethasone in patients with newly diagnosed multiple myeloma (MM): Final results of a multicenter phase I/II study.

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ASCO 2010: Lenalidomide, bortezomib, and dexamethasone in patients with newly diagnosed multiple myeloma (MM): Final results of a multicenter phase I/II study.

Paul Richardson, MD
Dana-Farber Cancer Institute
Boston, Massachusetts, USA

06.15.10

Author(s): K. C. Anderson, E. Weller, S. Lonial, A. J. Jakubowiak, S. Jagannath, N. S. Raje, D. Avigan, R. D. Knight, D. Esseltine, P. G. Richardson ABSTRACT: Background: Bortezomib (VELCADE, Bz) or lenalidomide (REVLIMID, Len) plus dexamethasone (dex) demonstrate substantial activity in front-line MM; the three-drug combination has shown efficacy in the relapsed setting. This was the first prospective study of the three-drug regimen in front-line MM. Methods: Patients (pts) received eight 3-wk cycles of Bz 1.0-1.3 mg/m2 (d 1, 4, 8, 11), Len 15-25 mg (d 1-14), and dex 40 or 20 mg (d 1, 2, 4, 5, 8, 9, 11, 12) at 5 dose levels (phase I) and the maximum tolerated/planned dose (MTD; phase II). Responding pts could receive maintenance therapy or ASCT. Pts received prophylactic anticoagulants and anti-viral therapy. Primary endpoints were MTD and response rate. Results: 66 pts were treated (35 in phase II). Median age was 58 (range 22-86); 55% were men; 44%/47%/9% had ISS stage I/II/III MM; 68%/23%/9% had IgG/IgA /light chain MM; 57% had any of del 13q, del 17p, t(4;14), and t(11;14). Pts received a median of 10 cycles, including medians of 8, 10, and 8 cycles of Bz, Len, and dex, respectively. Two pts had dex-related DLT (grade 3 hyperglycemia, grade 3 ALT elevation). Phase II dosing was Bz 1.3 mg/m2, Len 25 mg, dex 20 mg. The most common toxicities were sensory neuropathy (80%), fatigue (64%), and constipation (61%), with only 2%, 3%, and 0% grade 3, respectively. Other grade 3/4 toxicities included lymphopenia (14%), neutropenia (9%), and thrombocytopenia (6%). Thrombosis was rare (6%). There was no treatment-related mortality. All pts achieved ≥PR to Len-Bz-dex (Table). Twenty- eight pts (42%) proceeded to ASCT. With median follow-up of 21 months, estimated 18-month PFS and overall survival rates among all pts after Len-Bz-dex with/without ASCT were 75% and 97%, respectively. Quality/rate of response and PFS appeared unaffected by adverse cytogenetic abnormalities. In a 1-yr landmark analysis, PFS was similar between ASCT/non-ASCT pts. Conclusions: Len-Bz-dex demonstrates favorable tolerability and is highly effective in newly diagnosed MM, with no impact seen from adverse cytogenetics on response or PFS, and similar outcomes with or without ASCT.

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ASCO 2010: Overview

ASCO 2010: Lenalidomide, bortezomib, and dexamethasone in patients with newly diagnosed multiple myeloma (MM): Final results of a multicenter phase I/II study.

ASCO 2010: Phase I study of combined vorinostat (V), lenalidomide (L), and dexamethasone (D) in patients (pts) with relapsed or refractory multiple myeloma (MM).

ASCO 2010: Phase Ib study of oral panobinostat (LBH589) plus lenalidomide (LEN) plus dexamethasone (DEX) in patients (Pts) with relapsed (Rel) or Rel and refractory (Ref) multiple myeloma (MM).

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ASCO 2010: Elotuzumab in combination with bortezomib in patients with relapsed/refractory multiple myeloma: A phase I study.

ASCO 2010: Lenalidomide, bortezomib, and dexamethasone in patients with newly diagnosed multiple myeloma (MM): Final results of a multicenter phase I/II study.

ASCO 2010: Total therapy 3 (TT3) for multiple myeloma (MM): Contributions to survival outcomes of dosing of maintenance components dexamethasone (D), thalidomide (T) and bortezomib (V).

ASCO 2010: Phase Ib study of oral panobinostat (LBH589) plus intravenous bortezomib in patients (Pts) with relapsed (Rel) or Rel and refractory (Ref) multiple myeloma (MM).

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ASCO 2010: Elotuzumab in combination with bortezomib in patients with relapsed/refractory multiple myeloma: A phase I study.

ASCO 2010: Phase I study of combined vorinostat (V), lenalidomide (L), and dexamethasone (D) in patients (pts) with relapsed or refractory multiple myeloma (MM).

ASCO 2010: Phase Ib study of oral panobinostat (LBH589) plus lenalidomide (LEN) plus dexamethasone (DEX) in patients (Pts) with relapsed (Rel) or Rel and refractory (Ref) multiple myeloma (MM).

ASCO 2010: Results of a phase I study of RAD001 in combination with lenalidomide in patients with relapsed or refractory multiple myeloma.

ASCO 2010: Results of an ongoing open-label, phase II study of carfilzomib in patients with relapsed and/or refractory multiple myeloma (R/R MM).

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ASCO 2010: Update on vantage program to assess combined vorinostat (V) and bortezomib (B) in patients (pts) with relapsed and/or refractory (RR) multiple myeloma (MM).

ASCO 2010: Dose-escalation study of carfilzomib (CFZ) plus lenalidomide (LEN) plus low-dose dexamethasone (Dex) (CRd) in relapsed/refractory multiple myeloma (R/R MM).

ASCO 2010: Phase Ib study of oral panobinostat (LBH589) plus intravenous bortezomib in patients (Pts) with relapsed (Rel) or Rel and refractory (Ref) multiple myeloma (MM).

ASCO 2010: Lenalidomide maintenance after transplantation for myeloma.

ASCO 2010: Modified high-dose melphalan and autologous stem cell transplantation (mHDM/SCT) in the treatment of AL amyloidosis (AL) and/or high-risk myeloma (hM): Analysis of a Southwest Oncology Group trial.

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