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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.
Shaji Kumar, MD
Mayo Clinic
Rochester, Minnesota, USA
06.09.10

Author(s): S. Kumar, J. Crowley, S. K. Klein, J. J. Lahuerta, J. Lee, P. Moreau, G. Morgan, P. G. Richardson, D. S. Siegel, B. G. Durie, on behalf of the International Myeloma Working Group (IMWG)


ABSTRACT:

Background: Outcome of patients (pts) with multiple myeloma (MM) has improved with the introduction of the immunomodulatory drugs (IMiD; thalidomide, lenalidomide) and the proteasome inhibitor bortezomib (Bz). However, MM remains incurable and new therapies are needed. Improvement with upcoming therapies needs to be measured in the context of outcome with the current therapies. Moreover, the natural history of MM with the newer therapies used currently remains unclear.

Methods: We designed a multicenter, retrospective study that enrolled 270 pts with relapsed MM, from 8 sites in US, 5 in Europe and 1 in Asia. Pts were refractory to Bz, defined as no response to prior Bz-containing regimen or disease progression within 60 days of a Bz-containing regimen. Pts also had to be relapsed, refractory, intolerant, and/or ineligible, to an IMiD. Clinical and lab data from diagnosis and individual relapses were collected. The date pts satisfied the above entry criteria was defined as time zero (T0).

Results: The median age at diagnosis was 58 years (range, 31-86) and median time from diagnosis to T0 was 32 months (mos) and 32% had > 3 prior regimens, including a transplant (SCT) in 60%. Following T0, 192 (71%) pts had a treatment recorded, including an SCT in 34 (13%). Various regimens were utilized after T0 (median=1; range 0-8). The first regimen following T0 contained Bz in 52 (27%) pts and an IMiD in 63 (33%) pts. An MR or better was seen to at least one therapy after T0 in 87 (45%) including > PR in 65 (34%) and > VGPR in 18 (9%). The probability of achieving a PR or better was higher for younger patients, those with a VGPR or better before T0 and those who received an SCT after T0. The median overall survival (OS) and event free survival (EFS) were 8 mos (95% CI; 6,10) and 5 mos (95% CI; 4,5 mos) respectively.

Conclusions: This study confirms the poor outcome of pts once they relapse and become refractory to novel agents. This observational dataset will provide context for interpreting ongoing clinical trials of new drugs for MM. SCT results in higher response rates, especially in those receiving it for the first time, and should be taken into account when defining populations for studies of new drugs.


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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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