PMID- 24014245
OWN - NLM
STAT- MEDLINE
DCOM- 20131227
LR  - 20220410
IS  - 1528-0020 (Electronic)
IS  - 0006-4971 (Print)
IS  - 0006-4971 (Linking)
VI  - 122
IP  - 18
DP  - 2013 Oct 31
TI  - Phase 2 dose-expansion study (PX-171-006) of carfilzomib, lenalidomide, and 
      low-dose dexamethasone in relapsed or progressive multiple myeloma.
PG  - 3122-8
LID - 10.1182/blood-2013-07-511170 [doi]
AB  - We previously reported a phase 1b dose-escalation study of carfilzomib, 
      lenalidomide, and low-dose dexamethasone (CRd) in relapsed or progressive 
      multiple myeloma where the maximum planned dose (MPD) was carfilzomib 20 mg/m2 
      days 1 and 2 of cycle 1 and 27 mg/m2 days 8, 9, 15, 16, and thereafter; 
      lenalidomide 25 mg days 1 to 21; and dexamethasone 40 mg once weekly on 28-day 
      cycles. Herein, we present results from the phase 2 dose expansion at the MPD, 
      focusing on the 52 patients enrolled in the MPD cohort. Median follow-up was 24.4 
      months. In the MPD cohort, overall response rate (ORR) was 76.9% with median time 
      to response of 0.95 month (range, 0.5-4.6) and duration of response (DOR) of 22.1 
      months. Median progression-free survival was 15.4 months. ORR was 69.2% in 
      bortezomib-refractory patients and 69.6% in lenalidomide-refractory patients with 
      median DOR of 22.1 and 10.8 months, respectively. A median of 9.5 (range, 1-45) 
      carfilzomib cycles were started with 7.7% of patients requiring carfilzomib dose 
      reductions and 19.2% discontinuing CRd due to adverse events (AEs). Grade 3/4 AEs 
      included lymphopenia (48.1%), neutropenia (32.7%), thrombocytopenia (19.2%), and 
      anemia (19.2%). CRd at the MPD was well tolerated with robust, rapid, and durable 
      responses.
FAU - Wang, Michael
AU  - Wang M
AD  - MD Anderson Cancer Center, Houston, TX;
FAU - Martin, Tom
AU  - Martin T
FAU - Bensinger, William
AU  - Bensinger W
FAU - Alsina, Melissa
AU  - Alsina M
FAU - Siegel, David S
AU  - Siegel DS
FAU - Kavalerchik, Edward
AU  - Kavalerchik E
FAU - Huang, Mei
AU  - Huang M
FAU - Orlowski, Robert Z
AU  - Orlowski RZ
FAU - Niesvizky, Ruben
AU  - Niesvizky R
LA  - eng
SI  - ClinicalTrials.gov/NCT00603447
GR  - P30 CA016672/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130906
PL  - United States
TA  - Blood
JT  - Blood
JID - 7603509
RN  - 0 (Oligopeptides)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - 72X6E3J5AR (carfilzomib)
RN  - 7S5I7G3JQL (Dexamethasone)
RN  - F0P408N6V4 (Lenalidomide)
SB  - IM
CIN - Blood. 2013 Oct 31;122(18):3092-3. PMID: 24178959
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Dexamethasone/administration & dosage/adverse effects
MH  - Diarrhea/chemically induced
MH  - Disease Progression
MH  - Disease-Free Survival
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Fatigue/chemically induced
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Lenalidomide
MH  - Lymphopenia/chemically induced
MH  - Male
MH  - Middle Aged
MH  - Multiple Myeloma/*drug therapy/pathology
MH  - Neoplasm Recurrence, Local
MH  - Neutropenia/chemically induced
MH  - Oligopeptides/administration & dosage/adverse effects
MH  - Remission Induction
MH  - Thalidomide/administration & dosage/adverse effects/analogs & derivatives
MH  - Treatment Outcome
PMC - PMC3814729
EDAT- 2013/09/10 06:00
MHDA- 2013/12/29 06:00
PMCR- 2013/10/31
CRDT- 2013/09/10 06:00
PHST- 2013/09/10 06:00 [entrez]
PHST- 2013/09/10 06:00 [pubmed]
PHST- 2013/12/29 06:00 [medline]
PHST- 2013/10/31 00:00 [pmc-release]
AID - S0006-4971(20)36410-7 [pii]
AID - 2013/511170 [pii]
AID - 10.1182/blood-2013-07-511170 [doi]
PST - ppublish
SO  - Blood. 2013 Oct 31;122(18):3122-8. doi: 10.1182/blood-2013-07-511170. Epub 2013 
      Sep 6.