Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma
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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; Vacca, Angelo; Blanchard, María Jesús; Goldschmidt, Hartmut; Doyen, Chantal; Kaiser, Martin; Petrini, Mario; Anttila, Pekka; Cafro, Anna Maria; Raymakers, Reinier; San-Miguel, Jesus; de Arriba, Felipe; Knop, Stefan; Röllig, Christoph; Ocio, Enrique M; Morgan, Gareth; Miller, Neil; Simcock, Mathew; Peluso, Teresa; Herring, Jennifer; Sternas, Lars; Zaki, Mohamed H; Moreau, Philippe.
In: BLOOD, Vol. 128, No. 4, 28.07.2016, p. 497-503.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma
AU - Dimopoulos, Meletios A
AU - Palumbo, Antonio
AU - Corradini, Paolo
AU - Cavo, Michele
AU - Delforge, Michel
AU - Di Raimondo, Francesco
AU - Weisel, Katja C
AU - Oriol, Albert
AU - Hansson, Markus
AU - Vacca, Angelo
AU - Blanchard, María Jesús
AU - Goldschmidt, Hartmut
AU - Doyen, Chantal
AU - Kaiser, Martin
AU - Petrini, Mario
AU - Anttila, Pekka
AU - Cafro, Anna Maria
AU - Raymakers, Reinier
AU - San-Miguel, Jesus
AU - de Arriba, Felipe
AU - Knop, Stefan
AU - Röllig, Christoph
AU - Ocio, Enrique M
AU - Morgan, Gareth
AU - Miller, Neil
AU - Simcock, Mathew
AU - Peluso, Teresa
AU - Herring, Jennifer
AU - Sternas, Lars
AU - Zaki, Mohamed H
AU - Moreau, Philippe
N1 - © 2016 by The American Society of Hematology.
PY - 2016/7/28
Y1 - 2016/7/28
N2 - 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.
AB - 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.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Dexamethasone
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Male
KW - Middle Aged
KW - Multiple Myeloma
KW - Thalidomide
KW - Clinical Trial, Phase III
KW - Journal Article
KW - Multicenter Study
KW - Research Support, Non-U.S. Gov't
U2 - 10.1182/blood-2016-02-700872
DO - 10.1182/blood-2016-02-700872
M3 - SCORING: Journal article
C2 - 27226434
VL - 128
SP - 497
EP - 503
JO - BLOOD
JF - BLOOD
SN - 0006-4971
IS - 4
ER -
