Combination Therapy with CC-5013
(Lenalidomide; RevlimidTM ) plus
Dexamethasone (Rev/Dex) for Newly
Diagnosed Myeloma
S. Vincent Rajkumar, Suzanne R Hayman, Martha Q
Lacy, Angela Dispenzieri, Antje Hoering, Susan M
Geyer, Steven R Zeldenrust, Philip R Greipp, Rafael
Fonseca, John A Lust, Stephen J Russell, Robert A
Kyle, Thomas E Witzig, and Morie A Gertz
Mayo Clinic, Rochester, MN.

E1A00
Best Response within 4 Cycles using ECOG criteria
· Thal/Dex: 63%
· Dex:
41%
Corrected Best Response within 4 Cycles
· Thal/Dex: 73%
· Dex:
50%
Rajkumar SV ASCO 2004; Rajkumar SV ASH 2004

E1A00
Grade 3 or higher non-hematologic toxicities within 4
cycles
· Thal/Dex: 66%
· Dex:
43%

Thalidomide
CC 5013 (Lenalidomide)
Richardson et al, DeVita PPO updates. Feb 2001

Aim
· A phase II trial of CC-5013 plus
dexamethasone (Rev/Dex) as induction
therapy for newly diagnosed myeloma

Schema
R
SCT Planned:
E
Off Rx @ 4 months
G
I
CR/PR/
S
Stable
T
CC-5013 + Dex
R
No SCT : Can
A
continue Rx at MD
T
discretion
I
Off Rx
Prog
O
N

Study Therapy
CC-5013
Dexamethasone
· 25 mg PO daily on
· 40 mg days 1-4, 9-12,
days 1-21
17-20
All pts received Aspirin once a day as DVT prophylaxis

Response Definition
Partial Response
· >50% reduction in serum M protein
· > 90% reduction in urine M protein, or
reduction to <200 mg
· Responses need to be confirmed at least 4
weeks apart

Patients
· 30 Patients
· 19 Men and 11 Women
· March 2004-September 2004
· Median Age: 64 (Range, 32-78)
· Beta 2-microglobulin >2.7
57%
· BMPC >40%
31%

Results
Partial Response
· 25/30 pts (83%)

Results
Of 5 "non-responders"
· 2 await response confirmation
· 2 pts have a >50% decrease in M protein
· 1 true non-responder

Results: Hematologic Toxicity
Grade 1-2
Grade 3-4
· Anemia
3%
7%
· Neutropenia
17%
3%
· Lymphopenia
17%
3%
· Other grade 3-4 occurring in 1pt each: CD4 Count, Other
(Transfusion of 2 Units of PRBC)

Results: Non-Hematologic Toxicity
Grade 1-2
Grade 3
· DVT
0%
0%
· Constipation
7%
0%
· Sedation
30%
7%
· Rash
3%
3%
· Neuropathy
17%
0%
· Anxiety
7%
7%
·
Other grade 3 occurring in 1pt each: Hyperglycemia, LE Weakness,
UE Weakness, Pneumonitis, Atrial Fibrillation, Ventricular
Tachycardia, Colonic Perforation, Ehrlichiosis infection

Results: Non-Hematologic Toxicity
Grade 3 non-hematologic toxicities: 10/30 (33%)
patients
No Grade 4 toxicities

Conclusions
· Rev/Dex is active and well tolerated in the treatment of
newly diagnosed MM and is a potential alternative to
Thal/Dex.
· These results need to be confirmed in the final analysis of
this trial.
· A large randomized trial using Rev/Dex as initial therapy for
MM has been activated by the Eastern Cooperative
Oncology Group.

ECOG/CTSU Randomized Phase III Trial in Newly
Diagnosed Myeloma (E4A03)
R
412 pts
A
N
@ 4 months
D
Rev + Dex
CR/PR
Pts eligible for SCT
O
x4 cycles
proceed to SCT*
M
I
Z
Rev + Low
A
Rev +
Less
Thal + Dex
dose Dex
T
dose
CR/PR/Stable
than
x 4 cycles
x 4 cycles
I
x 4
PR
O
N

Document Outline