CLINICAL TRIAL UPDATES
A look at the ongoing clinical trials in multiple myeloma
PHASE III TRIALS
A Phase 3 Study Comparing Oral Ixazomib
Plus Lenalidomide and Dexamethasone
Versus Placebo Plus Lenalidomide and
Dexamethasone in Adult Patients With
Relapsed and/or Refractory Multiple
Myeloma (NCT01564537)
• STUDY DESIGN: Randomized, doubleblind, parallel assignment safety/efficacy study
• STUDY START DATE: August 2012
• ESTIMATED STUDY COMPLETION DATE:
May 2019
• STUDY STATUS: This study is ongoing,
but not recruiting participants.
• ESTIMATED ENROLLMENT: 837
• SPONSOR: Millennium Pharmaceuticals,
Inc.
This trial compares the use of ixazomib
(the first oral proteasome inhibitor) in
combination with lenalidomide and weekly
dexamethasone with the standard of care.
Once again, this three-drug regimen is first
being studied in the relapsed/refractory
multiple myeloma population, but trials in
newly diagnosed patients are also underway. A positive study would launch the first
oral combination therapy incorporating
the most active targeted pathways in this
disease – with the potential to dramatically
improve convenience for patients. Ixazomib
is also being investigated in newly diagnosed
multiple myeloma (NCT01850524) and as
maintenance therapy in patients with multiple myeloma following autologous stem cell
transplantation (NCT02181413).
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab
to Treat Newly Diagnosed, Previously
Untreated Multiple Myeloma (ELOQUENT
- 1) (NCT01335399)
• STUDY DESIGN: Randomized, open-label,
parallel assignment efficacy study
• STUDY START DATE: May 2011
• ESTIMATED STUDY COMPLETION DATE:
July 2020
• STUDY STATUS: This study is ongoing,
but not recruiting participants.
• ESTIMATED ENROLLMENT: 750
• SPONSOR: Bristol-Myers Squibb
The purpose of this study is to determine
whether the addition of elotuzumab to
lenalidomide and low-dose dexamethasone
will increase the progression-free survival
compared with lenalidomide and low-dose
dexamethasone alone in patients with
newly diagnosed multiple myeloma.
Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose
Treatment With SCT in MM Patients up to
Age 65 (DFCI 10-106) (NCT01208662)
• STUDY DESIGN: Randomized, open-label,
parallel assignment safety/efficacy
study
• STUDY START DATE: September 2010
• ESTIMATED STUDY COMPLETION DATE:
September 2018
• STUDY STATUS: Currently recruiting
participants
• ESTIMATED ENROLLMENT: 660
• SPONSOR: Dana-Farber Cancer Institute
This study is exploring the safety and efficacy of the combination of lenalidomide,
bortezomib, and dexamethasone alone
or when combined with autologous stem
cell transplantation in patients with newly
diagnosed multiple myeloma. Specifically,
the objective of this trial is to determine if,
in the era of novel drugs, high-dose therapy
is still necessary in the initial management
of multiple myeloma in younger patients.
In this study, high-dose therapy will be
considered superior to conventional-dose
treatment if it prolongs progression-free
survival by at least nine months or more.
Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With
Lenalidomide and Dexamethasone in
Participants With Previously Untreated
Multiple Myeloma (NCT02252172)
• STUDY DESIGN: Randomized, open-label,
parallel assignment efficacy study
• STUDY START DATE: February 2015
• ESTIMATED STUDY COMPLETION DATE:
November 2022
• STUDY STATUS: Currently recruiting
participants
• ESTIMATED ENROLLMENT: 730
• SPONSOR: Janssen Research & Development, LLC
The purpose of this study is to compare
the efficacy of daratumumab in combination with lenalidomide and dexamethasone with that of lenalidomide and dexamethasone in terms of progression-free
survival (the primary endpoint) in patients
with newly diagnosed multiple myeloma
who are not candidates for high-dose
chemotherapy autologous hematopoietic
cell transplantation.
A Study in Subjects With Relapsed and
Refractory Multiple Myeloma Receiving Carfilzomib in Combination With
Dexamethasone, Comparing Once-Weekly
Versus Twice-Weekly Carfilzomib Dosi