CLINICAL TRIAL UPDATES
lidomide, and dexamethasone with the
combination of carfilzomib, lenalidomide,
and dexamethasone in treating patients
with newly diagnosed multiple myeloma.
PHASE II TRIALS
Phase 2b Open-Label Single-Arm Study
With KPT-330 + Dexamethasone in Patients
w/ Quad-Refractory Multiple Myeloma
(STORM) (NCT02336815)
• STUDY DESIGN: Single cohort, open-label
pilot study
• STUDY START DATE: May 2015
• ESTIMATED STUDY COMPLETION DATE:
November 2016
• STUDY STATUS: Currently recruiting
participants
• ESTIMATED ENROLLMENT: 80
• SPONSOR: Karyopharm Therapeutics, Inc.
This is a potential registration trial of
selinexor, a novel small molecule inhibitor
targeting the nuclear transport protein
exportin (XPO-1, also known as CRM-1)
in multiple myeloma. Early reports of
single-agent activity, as well as a 60
percent response rate in a study of 10
refractory patients who received selinexor
plus dexamethasone, prompted the design
of this trial, which will look at the safety
and efficacy of selinexor in heavily treated
patients with an unmet medical need.
--Study of ACY-1215 Alone and in Combination With Bortezomib and Dexamethasone
in Multiple Myeloma (NCT01323751)
• STUDY DESIGN: Open-label, single-group
assignment safety/efficacy study
• PHASE: I/II
• STUDY START DATE: July 2011
• ESTIMATED STUDY COMPLETION DATE:
September 2015
• STUDY STATUS: Currently recruiting
participants
• ESTIMATED ENROLLMENT: 120
• SPONSOR: Acetylon Pharmaceuticals
Incorporated; Leukemia and Lymphoma
Society
Phase Ia and Ib of this trial will evaluate the
safety and optimal dose of oral ACY-1215 as
monotherapy, and also in combination with
bortezomib and dexamethasone in patients
with relapsed or relapsed/refractory multiple myeloma. Phase IIa will determine the
8
Focus on Myeloma
objective response rate of oral ACY-1215 in
combination with bortezomib and dexamethasone in these patients.
PHASE I TRIALS
SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM
Patients (PomdeSAR) (NCT02283775)
• STUDY DESIGN: Open-label, single-group
assignment safety study
• STUDY START DATE: March 2015
• ESTIMATED STUDY COMPLETION DATE:
January 2017
• STUDY STATUS: Currently recruiting
participants
• ESTIMATED ENROLLMENT: 24
• SPONSOR: Sanofi
SAR650984 is a monoclonal antibody
targeting CD38 that is now being studied in
phase II combination studies, such as this
recently opened trial combining SAR650984
with pomalidomide and dexamethasone.
Safety Study in Nivolumab Alone and in
Combination With Ipilimumab or Lirilumab in Lymphoma and Multiple Myeloma
(NCT01592370)
• STUDY DESIGN: Non-randomized,
open-label, single-group assignment
safety study
• STUDY START DATE: June 2012
• ESTIMATED STUDY COMPLETION DATE:
were high: 20 patients (87%) experienced
an objective response, including 17 percent
with a complete response and 70 percent
with a partial response. Adverse events were
mainly low grade, with no life-threatening
adverse events. Based on these findings –
which support nivolumab-mediated PD-1
blockade as a promising targeted treatment
for these patients – the FDA has granted
nivolumab breakthrough status and a multinational phase II trial is underway.
--Dinaciclib, Bortezomib, and Dexamethasone in Treating Patients With Relapsed
Multiple Myeloma (NCT01711528)
• STUDY DESIGN: Non-randomized,
open-label, parallel assignment safety
study
• STUDY START DATE: December 2012
• ESTIMATED STUDY COMPLETION DATE: June
2016
• STUDY STATUS: Currently recruiting
participants
• ESTIMATED ENROLLMENT: 60
• SPONSOR: National Cancer Institute
This trial will establish the safety profile
and optimal dose of the combination of
dinaciclib (a novel cyclin-dependent kinase
inhibitor) and bortezomib, plus dexamethasone, in treating patients with relapsed
disease. Dinaciclib has demonstrated single-agent activity in this setting; combining
it with bortezomib and dexamethasone may
kill more cancer cells.
March 2018
• STUDY STATUS: Currently recruiting
participants
• ESTIMATED ENROLLMENT: 315
• SPONSOR: Bristol-Myers Squibb
This ongoing study is designed to determine the side effects of the PD-1 inhibitor
nivolumab alone and in combination with
ipilimumab or lirilumab. In a recent report by
Ansell et al. published in The New England
Journal of Medicine, nivolumab demonstrated strong response rates and acceptable safety in a cohort of 23 patients with
relapsed or refractory Hodgkin lymphoma.
Results were also presented at the 2014
ASH Annual Meeting. These heavily treated
patients had few other therapeutic options
available – 78 percent had relapsed after
autologous stem cell transplantation, and
78 percent had relapsed after treatment
wi