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ASCO 2010: Results of a phase I study of RAD001 in combination with lenalidomide in patients with relapsed or refractory multiple myeloma.
Noopur Raje, MD
Massachusetts General Cancer Center
Boston, Massachusetts, USA
06.15.10

Author(s): A. K. Mahindra, P. G. Richardson, P. Hari, J. Laubach, I. M. Ghobrial, R. L. Schlossman, E. Weller, N. C. Munshi, K. C. Anderson, N. S. Raje

ABSTRACT:

Background: Lenalidomide (Len) plus dexamethasone (Dex) is approved for the treatment of relapsed or relapsed/refractory multiple myeloma (MM) patients following >1 prior therapy. RAD001, an mTOR inhibitor has been studied as a single agent in MM and had no significant single-agent activity, but was well tolerated. Predicated upon our previous preclinical studies demonstrating synergistic anti-MM activity of mTOR inhibitors when combined with Len, we evaluated this combination as a non-steroid containing oral regimen in advanced MM.

Methods: Patients (pts) with relapsed and refractory MM were assigned to Len and RAD001 to be taken for 21 days of a 28 day cycle (NCT00729638). Pts were allowed to continue therapy until disease progression or unacceptable toxicity.

Results: Twenty-eight pts were registered on the trial;2 pts were replaced for rapidly progressive disease or failure to meet eligibility criteria on day 1. Data on 26 pts are currently available. Both cohort 1 and 2 required expansion because of grade 3 neutropenia and grade 4 thrombocytopenia. Dose limiting toxicities included grade 4 neutropenia and thrombocytopenia in 2/3 pts in cohort 3 (Len: 20 mg and RAD001: 5 mg x 21 days). The maximum tolerated dose (MTD) was therefore declared at 15 mg of Len and 5 mg of RAD001 for 21 days with a 7 day rest period. Most common (>10%) grade 1/2 events included nausea, fatigue, dyspnea, diarrhea, constipation, neuropathy and muscle cramps, all of which were manageable with supportive care. One pt developed RAD related non-infectious pneumonitis requiring discontinuation of therapy. Grade 3/4 adverse events > 5% included thrombocytopenia (11%) and neutropenia (22%). Nineteen pts completed 2 cycles and are evaluable for response: 12 pts received treatment at MTD. Overall response rate including MR + PR was 63% (90% CI: [30.76%]), with 1 pt achieving SD.

Conclusions: The combination of Len plus RAD001 is a well tolerated regimen with predictable hematological toxicities. The response rate to date has been encouraging in this heavily pretreated pt population. This combination provides an oral, steroid-sparing treatment strategy which warrants future evaluation in phase II studies.


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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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