PMID- 31101891
OWN - NLM
STAT- MEDLINE
DCOM- 20200917
LR  - 20221219
IS  - 1476-5365 (Electronic)
IS  - 0268-3369 (Linking)
VI  - 54
IP  - 11
DP  - 2019 Nov
TI  - A phase I/II study of escalating doses of thalidomide in conjunction with 
      bortezomib and high-dose melphalan as a conditioning regimen for autologous stem 
      cell transplantation in patients with multiple myeloma.
PG  - 1881-1891
LID - 10.1038/s41409-019-0534-0 [doi]
AB  - A regimen of escalating doses of thalidomide, in combination with bortezomib and 
      high-dose melphalan (mel/vel/thal), was evaluated as a conditioning regimen for 
      autologous stem cell transplantation (ASCT) in multiple myeloma (MM) patients 
      with a prior transplant who had relapsed or achieved less than a complete 
      remission following a prior ASCT. Thalidomide was dose escalated starting from 
      600 mg to 1000 mg on days -5 to -1 in a 3 x 3 design, bortezomib was administered 
      at 1.6 mg/m(2) intravenously on days -4 and -1 and melphalan 200 mg/m(2) was 
      administered on day -2. No dose-limiting toxicity was seen in the phase I portion 
      of the trial. An additional 20 patients were enrolled at the maximum tolerated 
      dose of thalidomide of 1000 mg daily. The overall response rate was 69% with 38% 
      complete remission. Median PFS and OS were 9.3 and 65.4 months, respectively, 
      with a median follow-up of 17.8 months. The most common grade 3-4 adverse events 
      (AEs) were neutropenic fever (58.6%), mucositis (6.9%), and diarrhea (6.9%). 
      Serious AEs included somnolence (13.8%) and tumor lysis syndrome (3.4%). The 
      addition of high-dose thalidomide to bortezomib and melphalan as conditioning for 
      salvage ASCT was well tolerated and was an effective conditioning regimen.
FAU - Biran, Noa
AU  - Biran N
AD  - John Theurer Cancer Center at Hackensack Meridian, Seton Hall University School 
      of Medicine, Hackensack, NJ, USA. Noa.Biran@hackensackmeridian.org.
FAU - Rowley, Scott D
AU  - Rowley SD
AD  - John Theurer Cancer Center at Hackensack Meridian, Seton Hall University School 
      of Medicine, Hackensack, NJ, USA.
FAU - Vesole, David H
AU  - Vesole DH
AD  - John Theurer Cancer Center at Hackensack Meridian, Seton Hall University School 
      of Medicine, Hackensack, NJ, USA.
FAU - Zhang, Shijia
AU  - Zhang S
AUID- ORCID: 0000-0002-7423-9255
AD  - University of Minnesota School of Medicine, Minneapolis, MN, USA.
FAU - Donato, Michele L
AU  - Donato ML
AD  - John Theurer Cancer Center at Hackensack Meridian, Seton Hall University School 
      of Medicine, Hackensack, NJ, USA.
FAU - Skarbnik, Alan P
AU  - Skarbnik AP
AD  - Novant Health, Charlotte, NC, USA.
FAU - Richter, Joshua
AU  - Richter J
AD  - Icahn School of Medicine at Mount Sinai, New York, NY, USA.
FAU - Pecora, Andrew
AU  - Pecora A
AD  - John Theurer Cancer Center at Hackensack Meridian, Seton Hall University School 
      of Medicine, Hackensack, NJ, USA.
FAU - Siegel, David S
AU  - Siegel DS
AD  - John Theurer Cancer Center at Hackensack Meridian, Seton Hall University School 
      of Medicine, Hackensack, NJ, USA.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20190517
PL  - England
TA  - Bone Marrow Transplant
JT  - Bone marrow transplantation
JID - 8702459
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - 69G8BD63PP (Bortezomib)
RN  - Q41OR9510P (Melphalan)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Autografts
MH  - Bortezomib/*administration & dosage/adverse effects
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Male
MH  - Melphalan/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - *Multiple Myeloma/mortality/therapy
MH  - Survival Rate
MH  - Thalidomide/*administration & dosage/adverse effects
MH  - *Transplantation Conditioning
EDAT- 2019/05/19 06:00
MHDA- 2020/09/18 06:00
CRDT- 2019/05/19 06:00
PHST- 2018/10/03 00:00 [received]
PHST- 2019/04/12 00:00 [accepted]
PHST- 2019/02/27 00:00 [revised]
PHST- 2019/05/19 06:00 [pubmed]
PHST- 2020/09/18 06:00 [medline]
PHST- 2019/05/19 06:00 [entrez]
AID - 10.1038/s41409-019-0534-0 [pii]
AID - 10.1038/s41409-019-0534-0 [doi]
PST - ppublish
SO  - Bone Marrow Transplant. 2019 Nov;54(11):1881-1891. doi: 
      10.1038/s41409-019-0534-0. Epub 2019 May 17.