PMID- 24650009
OWN - NLM
STAT- MEDLINE
DCOM- 20140731
LR  - 20211021
IS  - 1365-2141 (Electronic)
IS  - 0007-1048 (Print)
IS  - 0007-1048 (Linking)
VI  - 165
IP  - 6
DP  - 2014 Jun
TI  - Sotatercept in patients with osteolytic lesions of multiple myeloma.
PG  - 814-23
LID - 10.1111/bjh.12835 [doi]
AB  - This phase IIa study evaluated the safety and tolerability of sotatercept, and 
      its effects on bone metabolism and haematopoiesis in newly diagnosed and relapsed 
      multiple myeloma (MM) patients. Patients were randomized (4:1) to receive four 
      28-d cycles of sotatercept (0.1, 0.3, or 0.5 mg/kg) or placebo. Patients also 
      received six cycles of combination oral melphalan, prednisolone, and thalidomide 
      (MPT). Thirty patients were enrolled; six received placebo and 24 received 
      sotatercept. Overall, 25% of patients received all four sotatercept doses; 71% of 
      sotatercept-treated patients had >/=1 dose interruption mainly due to increases in 
      haemoglobin levels. Grade >/=3 adverse events (AEs) were reported in 17% of 
      patients receiving placebo and 58% receiving sotatercept. Grade 4 AEs in 
      sotatercept-treated patients were neutropenia, granulocytopenia, and atrial 
      fibrillation (one patient each). In patients without bisphosphonate use, anabolic 
      improvements in bone mineral density and in bone formation relative to placebo 
      occurred, whereas bone resorption was minimally affected. Increases in 
      haemoglobin levels, versus baseline, and the duration of the increases, were 
      higher in the sotatercept-treated patients, with a trend suggesting a 
      dose-related effect. Multiple doses of sotatercept plus MPT appear to be safe and 
      generally well-tolerated in MM patients.
CI  - (c) 2014 The Authors. British Journal of Haematology published by John Wiley & Sons 
      Ltd.
FAU - Abdulkadyrov, Kudrat M
AU  - Abdulkadyrov KM
AD  - Russian Research Institute of Haematology and Blood Transfusion, St Petersburg, 
      Russia.
FAU - Salogub, Galina N
AU  - Salogub GN
FAU - Khuazheva, Nuriet K
AU  - Khuazheva NK
FAU - Sherman, Matthew L
AU  - Sherman ML
FAU - Laadem, Abderrahmane
AU  - Laadem A
FAU - Barger, Rachel
AU  - Barger R
FAU - Knight, Robert
AU  - Knight R
FAU - Srinivasan, Shankar
AU  - Srinivasan S
FAU - Terpos, Evangelos
AU  - Terpos E
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140321
PL  - England
TA  - Br J Haematol
JT  - British journal of haematology
JID - 0372544
RN  - 0 (ACE-011)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Biomarkers)
RN  - 0 (Immunologic Factors)
RN  - 0 (Recombinant Fusion Proteins)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/administration & dosage/pharmacokinetics/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use
MH  - Biomarkers
MH  - Bone Density
MH  - Female
MH  - Humans
MH  - Immunologic Factors/administration & dosage/pharmacokinetics/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Multiple Myeloma/complications/*drug therapy/*pathology
MH  - Neoplasm Staging
MH  - Osteogenesis
MH  - Osteolysis/etiology/*pathology
MH  - Recombinant Fusion Proteins/administration & dosage/pharmacokinetics/*therapeutic 
      use
MH  - Treatment Outcome
PMC - PMC4312883
OTO - NOTNLM
OT  - anaemia
OT  - bone disease
OT  - haematopoiesis
OT  - multiple myeloma
OT  - sotatercept
EDAT- 2014/03/22 06:00
MHDA- 2014/08/01 06:00
CRDT- 2014/03/22 06:00
PHST- 2013/12/18 00:00 [received]
PHST- 2014/02/05 00:00 [accepted]
PHST- 2014/03/22 06:00 [entrez]
PHST- 2014/03/22 06:00 [pubmed]
PHST- 2014/08/01 06:00 [medline]
AID - 10.1111/bjh.12835 [doi]
PST - ppublish
SO  - Br J Haematol. 2014 Jun;165(6):814-23. doi: 10.1111/bjh.12835. Epub 2014 Mar 21.