Pomalidomide and Dexamethasone in Relapsed Myeloma: Results of
225 Patients Treated in Five Cohorts Over Three Years
Martha Q. Lacy1, Betsy LaPlant 2, Kristina Laumann 2,Morie A. Gertz1, Suzanne R. Hayman1, Francis Buadi 1, Angela Dispenzieri 1, Shaji Kumar 1, John A. Lust 1, Stephen J Russell 1, David Dingli 1, Steven
Zeldenrust 1, Philip Greipp 1, Rafael Fonseca 3, P. Leif Bergsagel 3,Vivek Roy 4, A. Keith Stewart 3, Craig Reeder 2, Robert Hall 1, S. Vincent Rajkumar 1, Joseph R. Mikhael 3
Hematology, Mayo Clinic, Rochester, MN1; Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN 2, Mayo Clinic Arizona, Scottsdale, AZ3; Mayo Clinic Florida, Jacksonville, FL 4
Abstract
Methods
Hematologic Toxicity
Non-Hematologic Adverse Events
Progression Free Survival
Background: Pomalidomide at doses of 2 or 4 mg/d has
The five cohorts consisted of:
· Lorem ipsum dolor sit amet, consectetur adipiscing elit. Duis
· Lorem ipsum dolor sit amet, consectetur adipiscing elit. Duis eu
Published
No. of
Yield 1
Yield 2
demonstrated excellent activity in patients with relapsed multiple
eu sapien metus. Duis vestibulum tincidunt felis, at euismod
sapien
Cohort 1 (N=60): relapsed MM with 1-3 prior regimens, 2 mg dose;
Study
Patients (%)
(%)
(%)
myeloma (MM). Between November 2007 and November 2010,
dolor alaeque sit amet.
metus. Duis vestibulum tincidunt felis, at euismod dolor aliquam sit
we opened 5 sequential phase 2 trials using the pomalidomide at
Cohort 2 (N=34): lenalidomide refractory, 2 mg dose;
· Lorem ipsum dolor sit amet, consectetur adipiscing elit. Duis
Study A 2002
13
0
46
amet.
differing doses with weekly dexamethasone (Pom/dex) regimen to
eu sapien metus. Duis vestibulum tincidunt felis, at euismod
· Lorem ipsum dolor sit amet, consectetur adipiscing elit. Duis eu
study the efficacy of this regimen.
Cohort 3 (N=35): bortezomib/lenalidomide refractory, 2 mg dose;
Study A 2003
17
0
71
dolor aliquam sit amet.
sapien metus. Duis vestibulum tincidunt felis, at euismod dolor
Cohort 4 (N=35): bortezomib/lenalidomide refractory, 4 mg dose;
Study B 2003
21
0
43
aliquam sit amet. Aliquam et erat ac ligula vehicula lacinia. Nam
Adndnd Lorem ipsum dolor sit amet, consectetur Lorem
and
eget orci libero. Vivamus urnamassa, aliquam sit amet faucibus quis,
Methods: The five cohorts consisted of: Cohort 1 (N=60): relapsed
ipsum dolor sit amet, consectetur Lorem ipsum dolor sit
Study A 2004
17
0
71
scelerisque aliquam orci. Nunceget metus enim. Curabitur eget
MM with 1-3 prior regimens, 2 mg dose; Cohort 2 (N=34):
Cohort 5 (N=60) lenalidomide refractory, 1-3 prior regimens, 4 mg
amet, consectetur.
tortor id massa viverra mattis. Vestibulum cursus nisi et massa
lenalidomide refractory, 2 mg dose; Cohort 3 (N=35):
dose.
Study B 2004
50
32
60
· Curabitur eget tortor id massa viverra mattis.
bortezomib/lenalidomide refractory, 2 mg dose; Cohort 4 (N=35):
Pomalidomide was given orally 2 mg daily or 4mg daily on days 1
Vestibulum cursus nisi et massa placerat auctor.
Study C 2004
88
--
70
bortezomib/lenalidomide refractory, 4 mg dose; and Cohort 5
28 of a 28-day cycle with oral dexamethasone given 40 mg daily on
Integer feugiat posuere.
(N=60) lenalidomide refractory, 1-3 prior regimens, 4 mg dose.
days 1, 8, 15 and 22. Response was assessed by the International
Pomalidomide was given orally 2 mg daily or 4mg daily on days 1
Conclusions
· Lorem ipsum dolor sit amet, consectetur adipiscing elit. Duis
Figure legend sdfkj uwer lkjfsjkasd iudfudfad lkdf wer erwrewjr lkdjf dasfd
Myeloma Working Group Uniform Response criteria.
28 of a 28-day cycle with oral dexamethasone given 40 mg daily
sdfsdfssdfdf lkjf fd jsdffjdfjskdjf sldkfjl weruiou lkjf werj werj psfui lkjwer wl sdf
eu sapien metus. Duis vestibulum tincidunt felis, at euismod
.
on days 1, 8, 15 and 22. Response was assessed by the
All patients received aspirin 325 mg daily for DVT prophylaxis or full
dolor aliquam sit amet. Aliquam et erat ac ligula vehicula
· Pom/dex has remarkable activity in relapsed myeloma including
International Myeloma Working Group Uniform Response criteria.
dose anticoagulation with LMWH or warfarin.
lacinia. Nam eget orci libero. Vivamus urna massa, aliquam sit
heavily pre-treated population who are refractory to lenalidomide
All patients received aspirin 325 mg daily for DVT prophylaxis or
amet faucibus.
and bortezomib
full dose anticoagulation.
Results: A total of 225 patients were enrolled across all 5 cohorts.
Responses, MR or better
· Responses are rapid with median time to response 1 - 2 month
Prior Therapies
One patient was ineligible and excluded from analysis. The median
· Toxicity is manageable at both dose levels and consists primarily of
Patient Outcomes
age was 63 years (32.0-88.0). The median time since diagnosis
neutropenia
was 53 months. Forty percent had high-risk molecular markers.
Eighty-nine percent had received previous IMIDs including
· No evidence for dose response within the tested dose schedules;
100
ORR is similar between the 2 mg and 4 mg dose levels
thalidomide (53%) and lenalidomide (81%). Sixty-two percent had
previous bortezomib and 73% had prior transplant. The median
· Further studies ongoing to see if starting dose 4 mg for 21 of 28
follow-up is 12.6 months, but varies from 9.4 months for the most
80
days produces same response rates with less toxicity
recent cohort to 30 months for the first cohort. Sixty-nine percent
are alive and 30% remain progression free. Responses and
· Pomalidomide combinations should be explored.
toxicity are shown here.
60
here
Conclusions: Pom/dex is remarkably active and well tolerated
label
References
even in heavily pretreated patients. Responses are durable.
40
is
Response rates and toxicity are similar between the 2 mg and 4
Ax
1. Lacy MQ, Hayman SR, Gertz MA, et al. Pomalidomide (CC4047)
mg doses.
20
plus low-dose dexamethasone as therapy for relapsed multiple
myeloma. J Clin Oncol. 2009;27(30):5008-5014.
0
2. Lacy M, Mandrekar S, Gertz MAA, et al. Pomalidomide Plus
Low-Dose Dexamethasone In Myeloma Refractory to Both
Test A Test B Test C Test D Test E Test F
Bortezomib and Lenalidomide: Comparison of Two Dosing
Strategies In Dual-Refractory Disease. ASH Annual Meeting
Figure legend sdfkj uwer lkjfsjkasd iudfudfad lkdf wer erwrewjr lkdjf
Figure legend sdfkj uwer lkjfsjkasd iudfudfad lkdf wer erwrewjr lkdjf dasfd
Disclosure: Dr. Lacy has funding for
dasfd sdfsdfssdfdf lkjf fd jsdffjdfjskdjf sldkfjl weruiou lkjf werj werj psfui
Abstracts. 2010;116(21):863-.
sdfsdfssdfdf lkjf fd jsdffjdfjskdjf sldkfjl weruiou lkjf werj werj psfui lkjwer wl .
lkjwer wl sdf .
these trials from Celgene, Corp
3. Lacy MQ, Allred JB, Gertz MA, et al. Pomalidomide plus low-
dose dexamethasone in myeloma refractory to both bortezomib
and lenalidomide: comparison of 2 dosing strategies in dual-
refractory disease. Blood;118(11):2970-2975.
2011 Mayo Foundation for Medical Education and Research