ASH Clinical News | Page 22

Written in Blood

Phase 2 Results of the Carfilzomib, Thalidomide, and Dexamethasone
(KTd) Regimen in Multiple Myeloma Patients
Appropriate selection of induction and consolidation chemotherapy
regimens is essential to achieving the maximum response and improving outcomes for patients with multiple myeloma (MM) planning to
undergo autologous stem cell transplantation (ASCT). Recent phase 2
trial results suggest that transplant-eligible MM patients may benefit
from a new combination of agents for induction/consolidation therapy:

carfilzomib, thalidomide, and dexamethasone (KTd).
“This is the first study to evaluate KTd in transplant-eligible patients
with newly diagnosed MM and the first study in this setting to use a
carfilzomib-based regimen as both an induction and consolidation treatment strategy,” the authors, led by Peter Sonneveld, MD, PhD, from the
Erasmus University Medical Center in the Netherlands, wrote.
Dr. Sonneveld and colleagues examined
the safety and efficacy of the KTd regimen
in 91 previously untreated patients with
MM. During KTd induction therapy,
patients received four cycles of:

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• carfilzomib 20/27 mg/m2 (n=50), 20/36
mg/m2 (n=20), 20/45 mg/m2 (n=21), or
20/56 mg/m2 (n=20) on days 1, 2, 8, 9,
15, and 16 of a 28-day cycle
• thalidomide 200 mg on days 1-28
• dexamethasone 20 mg on days 1, 2, 8,
9, 15, and 16

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December 2014

During consolidation therapy, target doses
were: carfilzomib 27 mg/m2, 36 mg/m2,
45 mg/m2, or 56 mg/m2 respectively, and
thalidomide 50 mg. 
The response after induction therapy
was encouraging, the authors noted, with
90 percent of patients achieving at least a
partial response (PR), 25 percent achieving a complete remission (CR), and 68
percent achieving at least a “very good
partial response” (VGPR) – far exceeding the study’s primary endpoint of a ≥45
percent VGPR rate.
Furthermore, these responses were
rapid and continued to increase with
additional treatment, with 74 percent of
patients achieving partial or greater response within the first induction cycle and
93 percent after two induction cycles.
After ASCT, consolidation treatment with KTd resulted in a substantial
upgrade of response: 76 percent of
patients achieved greater than VGPR,
rising to 89 percent after four cycles of
consolidation therapy. At 36 months,
the progression-free survival rate was 72
percent (95% CI 60%–81%).
Overall, the KTd regimen was well
tolerated: only five patients (5%) discontinued induction therapy because
of excessive toxicity, and there were no
toxicity-related treatment discontinuations during consolidation therapy. In
general, for carfilzomib and thalidomide, more patients remained adherent
to each of the study drugs – with no
dose delays, reductions, or interruptions – during the consolidation period,
compared to the induction period.. Focusing on neurotoxicity, polyneuropathy
(PNP) was mostly grade 1/2, and the
majority of cases were attributable to
thalidomide; only 1 percent of patients
experienced grade 3/4 PNP.

January 2015