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Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010) : A phase 3b study in refractory multiple myeloma

Dimopoulos, Meletios A. ; Palumbo, Antonio ; Corradini, Paolo ; Cavo, Michele ; Delforge, Michel ; Di Raimondo, Francesco ; Weisel, Katja C. ; Oriol, Albert ; Hansson, Markus LU orcid and Vacca, Angelo , et al. (2016) In Blood 128(4). p.497-503
Abstract

Patients with relapsed and/or refractory multiple myeloma (RRMM) have poor prognosis. The STRATUS study assessed safety and efficacy of pomalidomide plus low-dose dexamethasone in the largest cohort to date of patients with RRMM. Patients who failed treatment with bortezomib and lenalidomide and had adequate prior alkylator therapy were eligible. Pomalidomide 4 mg was given on days 1-21 of 28-day cycles with low-dose dexamethasone 40 mg (20 mg for patients aged >75 years) on days 1, 8, 15, and 22 until progressive disease or unacceptable toxicity. Safety was the primary end point; secondary end points included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Among... (More)

Patients with relapsed and/or refractory multiple myeloma (RRMM) have poor prognosis. The STRATUS study assessed safety and efficacy of pomalidomide plus low-dose dexamethasone in the largest cohort to date of patients with RRMM. Patients who failed treatment with bortezomib and lenalidomide and had adequate prior alkylator therapy were eligible. Pomalidomide 4 mg was given on days 1-21 of 28-day cycles with low-dose dexamethasone 40 mg (20 mg for patients aged >75 years) on days 1, 8, 15, and 22 until progressive disease or unacceptable toxicity. Safety was the primary end point; secondary end points included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Among 682 patients enrolled, median age was 66 years, and median time since diagnosis was 5.3 years. Median number of prior regimens was 5. Most patients were refractory to both lenalidomide and bortezomib (80.2%). Median follow-up was 16.8 months; median duration of treatment was 4.9 months. Most frequent grade 3/4 treatment-emergent adverse events were hematologic (neutropenia [49.7%], anemia [33.0%], and thrombocytopenia [24.1%]). Most common grade 3/4 nonhematologic toxicities were pneumonia (10.9%) and fatigue (5.9%). Grade 3/4 venous thromboembolism and peripheral neuropathy were rare (1.6% each). The ORR was 32.6%, and the median DOR was 7.4 months. Median PFS and OS were 4.6 months and 11.9 months, respectively. We present the largest trial to date evaluating pomalidomide plus low-dose dexamethasone in patients with RRMM, further confirming that this regimen offers clinically meaningful benefit and is generally well tolerated. www.Clinicaltrials.gov identifier NCT01712789.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Blood
volume
128
issue
4
pages
7 pages
publisher
American Society of Hematology
external identifiers
  • scopus:84979912946
  • pmid:27226434
  • wos:000383947300007
ISSN
0006-4971
DOI
10.1182/blood-2016-02-700872
language
English
LU publication?
yes
id
205f86c9-939c-494a-8f5d-5d5e2331ca17
date added to LUP
2016-08-29 14:32:50
date last changed
2024-05-31 12:05:43
@article{205f86c9-939c-494a-8f5d-5d5e2331ca17,
  abstract     = {{<p>Patients with relapsed and/or refractory multiple myeloma (RRMM) have poor prognosis. The STRATUS study assessed safety and efficacy of pomalidomide plus low-dose dexamethasone in the largest cohort to date of patients with RRMM. Patients who failed treatment with bortezomib and lenalidomide and had adequate prior alkylator therapy were eligible. Pomalidomide 4 mg was given on days 1-21 of 28-day cycles with low-dose dexamethasone 40 mg (20 mg for patients aged &gt;75 years) on days 1, 8, 15, and 22 until progressive disease or unacceptable toxicity. Safety was the primary end point; secondary end points included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Among 682 patients enrolled, median age was 66 years, and median time since diagnosis was 5.3 years. Median number of prior regimens was 5. Most patients were refractory to both lenalidomide and bortezomib (80.2%). Median follow-up was 16.8 months; median duration of treatment was 4.9 months. Most frequent grade 3/4 treatment-emergent adverse events were hematologic (neutropenia [49.7%], anemia [33.0%], and thrombocytopenia [24.1%]). Most common grade 3/4 nonhematologic toxicities were pneumonia (10.9%) and fatigue (5.9%). Grade 3/4 venous thromboembolism and peripheral neuropathy were rare (1.6% each). The ORR was 32.6%, and the median DOR was 7.4 months. Median PFS and OS were 4.6 months and 11.9 months, respectively. We present the largest trial to date evaluating pomalidomide plus low-dose dexamethasone in patients with RRMM, further confirming that this regimen offers clinically meaningful benefit and is generally well tolerated. www.Clinicaltrials.gov identifier NCT01712789.</p>}},
  author       = {{Dimopoulos, Meletios A. and Palumbo, Antonio and Corradini, Paolo and Cavo, Michele and Delforge, Michel and Di Raimondo, Francesco and Weisel, Katja C. and Oriol, Albert and Hansson, Markus and Vacca, Angelo and Blanchard, María Jesús and Goldschmidt, Hartmut and Doyen, Chantal and Kaiser, Martin and Petrini, Mario and Anttila, Pekka and Cafro, Anna Maria and Raymakers, Reinier and San-Miguel, Jesus and De Arriba, Felipe and Knop, Stefan and Röllig, Christoph and Ocio, Enrique M. and Morgan, Gareth and Miller, Neil and Simcock, Mathew and Peluso, Teresa and Herring, Jennifer and Sternas, Lars and Zaki, Mohamed H. and Moreau, Philippe}},
  issn         = {{0006-4971}},
  language     = {{eng}},
  month        = {{07}},
  number       = {{4}},
  pages        = {{497--503}},
  publisher    = {{American Society of Hematology}},
  series       = {{Blood}},
  title        = {{Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010) : A phase 3b study in refractory multiple myeloma}},
  url          = {{http://dx.doi.org/10.1182/blood-2016-02-700872}},
  doi          = {{10.1182/blood-2016-02-700872}},
  volume       = {{128}},
  year         = {{2016}},
}