1. Rafael Fonseca MD Chair, Department of Medicine Mayo Clinic in AZ What is the optimal therapeutic approach for MM patients with bor-len relapsed/refractory disease? Novel doublets ± corticosteroids
Scottsdale, Arizona
Rochester, Minnesota
Jacksonville, Florida
Mayo Clinic College of Medicine
Mayo Clinic Comprehensive Cancer Center

2. Disclosures
Consulting: AMGEN, Genzyme, BMS, Otsuka, Celgene, Medtronic, Lilly, Millennium, Binding Site, Onyx, Bayer
Speakers Bureaus: None
Research: Cylene, Proteolix
Patent for FISH based prognostication in MM - about $1500 per year
Registered independent
Believe in stem cell transplant
Dislike wasting your time with this slide

5. POM-V-D
1-4 lines of Rx (median 2)
Refractory to lenalidomide
(67% progressed as last Rx)
Not to bortezomib
>= 2 cycles bortezomib
28 pts enrolled, 20 evaluable for response
Bortezomib d 1, 4, 8, &11
1 & 8 after cycle 8

6. POM-V-D
MTD pomalidomide 4 mg and bortezomib 1.3 mg/m2
ORR is 75%
30% VGPR or better
One sCR
TTR is 1 month
Need larger randomized trials

7. A Phase I/II Trial of Pomalidomide, Bortezomib and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma
Joseph Mikhael MD1, Vivek Roy2, MD; Paul Richardson MD3; Andrzej Jakubowiak, MD4; Kristina Laumann5, Betsy LaPlant5; Angela Dispenzieri, MD5; S. Vincent Rajkumar, MD5; Rafael Fonseca, MD1; Nelson Leung, MD5; Francis K. Buadi, MD5, P. Leif Bergsagel; MD1, Robert A. Kyle, MD5; Thomas E. Witzig, MD5; Craig B. Reeder, MD; John A. Lust, MD, PhD5; Stephen J. Russell, MD, PhD5; Suzanne R. Hayman, MD5; Shaji Kumar, MD5; David Dingli, MD, PhD5; Stephen M. Ansell, MD, PhD5, Robert J. Dalton, MD5; Yi Lin, MD, PhD5, Taimur Sher, MD2, Prashant Kapoor, MD5, Arleigh McCurdy, MD5; Asher Chanan-Khan, MD2, A. Keith Stewart, MBCHB1; Morie A. Gertz, MD5, Martha Q. Lacy MD5

8. Results
A total of 25 patients have been accrued to the trial:
9 in phase I (3 at dose level 1 and 6 at dose level 2)
16 additional at dose level 2 for 22 total in phase II.

9. Results Phase I For the 9 patients in Phase I: Response in Phase I:
Median age was 63
33% were mSMART intermediate or high risk
Median number of prior regimens was 3
All patients had been treated with steroids and lenalidomide
89% had received and autologous stem cell transplant
Response in Phase I:
8/9 pts responded (5CR, 2 VGPR and 1 PR)

10. Results – Phase II For the 16 patients at dose level 2:
median age was 66,
31% percent had mSMART defined high risk status
Median prior lines of therapy was 3 (1-6),
100% treated with lenalidomide,
75% had stem cell transplant
50% had bortezomib
31% received thalidomide
Response rate is 94%:
5 CR, 4 VGPR and 6 PR.

11. Car-Pom-d

12. Car-Pom-d

13. Car-Pom-d

14. Car-Pom-d

15. Car-Pom-d

16. Car-Pom-d

17. Summary
Combinatorial strategies probably best
Unprecedented ability to induce response
Good DOR
Much more progress is needed!