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ASCO 2010: Phase III intergroup study of lenalidomide versus placebo maintenance therapy following single autologous stem cell transplant (ASCT) for multiple myeloma (MM): CALGB 100104.
Philip McCarthy, MD
Roswell Park Cancer Institute
Buffalo, New York, USA
06.10.10

Author(s): P. L. McCarthy, K. Owzar, K. C. Anderson, C. C. Hofmeister, H. Hassoun, D. D. Hurd, E. A. Stadtmauer, S. Giralt, V. Hars, C. A. Linker, for CALGB, ECOG and BMT-CTN


ABSTRACT:

Background: Disease relapse/progression is the primary cause of treatment failure after ASCT for MM.

Methods: The primary objective of CALGB 100104 was to investigate if maintenance lenalidomide would prolong time to progression (TTP) following single ASCT. Eligibility included: Stage I-III disease, < 1 year from diagnosis, > 2 months of induction with Stable Disease or better ( > SD) and age < 70 years. ASCT regimen was melphalan 200 mg/m2. Patients (pts) with > SD were randomized double-blind at day 100-110 post-ASCT to lenalidomide or placebo until disease progression, after stratification by diagnostic ß-2 microglobulin (ß-2M) level and prior thalidomide or lenalidomide therapy. Starting dose was 10 mg/day, escalated to 15 mg/day after 3 months. Drug was held for > Gr 3 toxicity, restarted at resolution to < Gr 2 and was de- escalated by 5 mg or maintained at 5, 10 or 15 mg/day as tolerated.

Results: 568 pts were enrolled (04/15/05 - 07/03/09). The second interim analysis, based on 418 randomized pts occurred on 09/09 after 28% of the required number of events (progression or death before progression) had been observed. The median follow-up was 12 months. The number of events among 210 pts randomized to lenalidomide was 29 compared to 58 among 208 pts randomized to placebo. The one-sided unadjusted P-value was < 0.0001. The estimated hazard ratio was 0.42 (95% CI=0.27,0.67) corresponding to a 58% reduction in event risk in the lenalidomide arm. The estimated median TTP was 25.5 months for the placebo arm. The median TTP has not been reached for the study arm. Deaths in the study and placebo arms were 11 and 17 respectively (P=0.2). Significant delay in TTP in the lenalidomide arm was observed regardless of ß-2M level or prior thalidomide or lenalidomide therapy. For 285 reported pts, the post-randomization, highest grade, overall AEs were Gr 3 (n=19), Gr 4 (n=111) and Gr 5 (n=1) for the lenalidomide arm and Gr 3 (n=4) Gr 4 (n=115) and Gr 5 (n=1) for placebo. The majority of AEs were hematologic in both arms.

Conclusions: Lenalidomide initiated at day 100-110 post-ASCT in MM patients significantly delays TTP and has a similar AE profile when compared to placebo.


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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).
ASCO 2010: Results of a phase I study of RAD001 in combination with lenalidomide in patients with relapsed or refractory multiple myeloma.
ASCO 2010: Lenalidomide maintenance after transplantation for myeloma.
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 III intergroup study of lenalidomide versus placebo maintenance therapy following single autologous stem cell transplant (ASCT) for multiple myeloma (MM): CALGB 100104.
ASCO 2010: Treatment patterns and outcome among patients with multiple myeloma relapsing and or refractory to bortezomib and immunomodulatory drugs: A multicenter International Myeloma Working Group study.
ASCO 2010: Elotuzumab in combination with lenalidomide and low-dose dexamethasone in relapsed or refractory multiple myeloma: A 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: Comparison of reduced-dose bortezomib plus thalidomide plus dexamethasone (vTD) to bortezomib plus dexamethasone (VD) as induction treatment prior to ASCT in de novo multiple myeloma (MM): Results of IFM2007-02 study.
ASCO 2010: Treatment patterns and outcome among patients with multiple myeloma relapsing and or refractory to bortezomib and immunomodulatory drugs: A multicenter International Myeloma Working Group study.
ASCO 2010: A phase II study of a modified pegylated liposomal doxorubicin (PLD), bortezomib, and dexamethasone regimen for patients with previously untreated multiple myeloma (MM).
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: Comparison of reduced-dose bortezomib plus thalidomide plus dexamethasone (vTD) to bortezomib plus dexamethasone (VD) as induction treatment prior to ASCT in de novo multiple myeloma (MM): Results of IFM2007-02 study.
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: Treatment patterns and outcome among patients with multiple myeloma relapsing and or refractory to bortezomib and immunomodulatory drugs: A multicenter International Myeloma Working Group study.
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: Response of newly diagnosed myeloma with 1q21 amplification to bortezomib-based PAD induction therapy.
A phase I study of IPH2101, a novel anti-inhibitory KIR monoclonal antibody, in patients with multiple myeloma.
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).
ASCO 2010: Mechanism of the antimyeloma activity of PU-H71, a novel purine scaffold HSP90 inhibitor.
ASCO 2010: Phase II study of carfilzomib in patients with relapsed/refractory multiple myeloma and renal insufficiency.
ASCO 2010: Elotuzumab in combination with lenalidomide and low-dose dexamethasone in relapsed or refractory multiple myeloma: A phase I/II study.
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.
ASCO 2010: Stromal elements and engraftment (ENG) in autologous hematopoietic progenitor cell transplant (autoHCT) for myeloma.
ASCO 2010: Comparison of reduced-dose bortezomib plus thalidomide plus dexamethasone (vTD) to bortezomib plus dexamethasone (VD) as induction treatment prior to ASCT in de novo multiple myeloma (MM): Results of IFM2007-02 study.
ASCO 2010: Phase III intergroup study of lenalidomide versus placebo maintenance therapy following single autologous stem cell transplant (ASCT) for multiple myeloma (MM): CALGB 100104.
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: Phase II study of carfilzomib in patients with relapsed/refractory multiple myeloma and renal insufficiency.
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).
ASCO 2010: Treatment patterns and outcome among patients with multiple myeloma relapsing and or refractory to bortezomib and immunomodulatory drugs: A multicenter International Myeloma Working Group study.
ASCO 2010: Elotuzumab in combination with lenalidomide and low-dose dexamethasone in relapsed or refractory multiple myeloma: A phase I/II study.
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: Bone marker assessment as a guide to chronic use of aminobisphosphonates in multiple myeloma.
ASCO 2010: Multiple myeloma is characterized by widespread epigenomic alterations with prognostic implications.
ASCO 2010: Evaluating the effects of zoledronic acid (ZOL) on overall survival (OS) in patients (Pts) with multiple myeloma (MM): Results of the Medical Research Council (MRC) Myeloma IX study.
ASCO 2010: Treatment patterns and outcome among patients with multiple myeloma relapsing and or refractory to bortezomib and immunomodulatory drugs: A multicenter International Myeloma Working Group study.


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