PMID- 19545290
OWN - NLM
STAT- MEDLINE
DCOM- 20091104
LR  - 20211020
IS  - 1365-2141 (Electronic)
IS  - 0007-1048 (Print)
IS  - 0007-1048 (Linking)
VI  - 146
IP  - 2
DP  - 2009 Jul
TI  - Expanded safety experience with lenalidomide plus dexamethasone in relapsed or 
      refractory multiple myeloma.
PG  - 164-70
LID - 10.1111/j.1365-2141.2009.07728.x [doi]
AB  - Lenalidomide gained Food and Drug Administration (FDA) approval for treatment of 
      patients with relapsed or refractory multiple myeloma (MM) in combination with 
      dexamethasone in June 2006. In April 2005, the FDA and patient advocacy groups 
      requested an expanded access programme to both provide lenalidomide to patients 
      likely to benefit and obtain additional safety information. Relapsed/refractory 
      MM patients received lenalidomide 25 mg/d (days 1-21) and dexamethasone 40 mg/d 
      (days 1-4, 9-12, and 17-20 of cycles 1-4; days 1-4 only from cycle 5 onwards), in 
      4-week cycles until disease progression, study drug discontinuation, or 
      lenalidomide approval. Of the 1438 patients enrolled, approximately 60% were 
      male, median age was 64 years, and 61.7% had Durie-Salmon stage III disease. 
      Median time on study was 15.4 weeks (range: 0.1-49.1) and median dose was 25 mg. 
      The most common adverse events (AEs) were haematological (49%), gastrointestinal 
      (59%), and fatigue (55%). The most common grade > or =3 AEs were haematological 
      (45%), fatigue (10%), and pneumonia (7%). The most common serious AEs were 
      pneumonia (8%), pyrexia (4%), and deep-vein thrombosis (3%). Primary cause of 
      death was disease progression (10%). Safety data confirmed known AEs of 
      lenalidomide plus dexamethasone therapy in patients with relapsed/refractory MM.
FAU - Chen, Christine
AU  - Chen C
AD  - Princess Margaret Hospital, Toronto, ON, Canada.
FAU - Reece, Donna E
AU  - Reece DE
FAU - Siegel, David
AU  - Siegel D
FAU - Niesvizky, Ruben
AU  - Niesvizky R
FAU - Boccia, Ralph V
AU  - Boccia RV
FAU - Stadtmauer, Edward A
AU  - Stadtmauer EA
FAU - Abonour, Rafat
AU  - Abonour R
FAU - Richardson, Paul
AU  - Richardson P
FAU - Matous, Jeffrey
AU  - Matous J
FAU - Kumar, Shaji
AU  - Kumar S
FAU - Bahlis, Nizar J
AU  - Bahlis NJ
FAU - Alsina, Melissa
AU  - Alsina M
FAU - Vescio, Robert
AU  - Vescio R
FAU - Coutre, Steven E
AU  - Coutre SE
FAU - Pietronigro, Dennis
AU  - Pietronigro D
FAU - Knight, Robert D
AU  - Knight RD
FAU - Zeldis, Jerome B
AU  - Zeldis JB
FAU - Rajkumar, Vincent
AU  - Rajkumar V
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20090526
PL  - England
TA  - Br J Haematol
JT  - British journal of haematology
JID - 0372544
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - 7S5I7G3JQL (Dexamethasone)
RN  - F0P408N6V4 (Lenalidomide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Dexamethasone/administration & dosage/adverse effects
MH  - Drug Resistance, Neoplasm
MH  - Female
MH  - Humans
MH  - Lenalidomide
MH  - Male
MH  - Middle Aged
MH  - Multiple Myeloma/*drug therapy
MH  - Recurrence
MH  - Thalidomide/administration & dosage/adverse effects/analogs & derivatives
MH  - Treatment Outcome
PMC - PMC2728892
EDAT- 2009/06/24 09:00
MHDA- 2009/11/05 06:00
CRDT- 2009/06/24 09:00
PHST- 2009/06/24 09:00 [entrez]
PHST- 2009/06/24 09:00 [pubmed]
PHST- 2009/11/05 06:00 [medline]
AID - BJH7728 [pii]
AID - 10.1111/j.1365-2141.2009.07728.x [doi]
PST - ppublish
SO  - Br J Haematol. 2009 Jul;146(2):164-70. doi: 10.1111/j.1365-2141.2009.07728.x. 
      Epub 2009 May 26.