Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUSTM (MM-010): a phase 3b study in refractory multiple myeloma
Dimopoulos MA (1), Palumbo A (2), Corradini P (3), Cavo M (4), Delforge M (5), Di Raimondo F (6), Weisel KC (7), Oriol A (8), Hansson M (9), Vacca A (10), Blanchard MJ (11), Goldschmidt H (12), Doyen C (13), Kaiser M (14), Petrini M (15), Anttila P (16), Cafro AM (17), Raymakers R (18), San Miguel J (19), de Arriba F (20), Knop S (21), Röllig C (22), Ocio EM (23), Morgan G (24), Miller N (25), Simcock M (25), Peluso T (25), Herring J (26), Sternas L (26), Zaki M (26), Moreau P (27).
(1) National and Kapodistrian University of Athens, Athens, Greece;
(2) University of Turino, Turino, Italy;
(3) University of Milano, Fondazione IRCCS Istituto Nazionale de Tumori, Milano, Italy;
(4) Bologna University School of Medicine, Bologna, Italy;
(5) University Hospital Leuven, Leuven, Belgium;
(6) University of Catania, Catania, Italy;
(7) University Hospital of Tuebingen, Tuebingen, Germany;
(8) Institut Catala d'Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain;
(9) Skane University Hospital, Lund University, Lund, Sweden;
(10) University of Bari Medical School, Bari, Italy;
(11) Hospital Ramon y Cajal, Madrid, Spain;
(12) University Hospital Heidelberg and German Cancer Research Center, Heidelberg, Germany;
(13) Universite catholique de Louvain, CHU Ucl Namur, Yvoir, Belgium;
(14) The Royal Marsden Hospital, Surrey, United Kingdom;
(15) Santa Chiara Hospital University of Pisa, Pisa, Italy;
(16) Helsinki University Hospital Comprehensive Cancer Center and University of Helsinki, Helsinki, Finland;
(17) Hospedale Niguarda Ca' Granda, Milan, Italy;
(18) University Medical Center Utrecht, Utrecht, Netherlands;
(19) Clinica Universidad de Navarra, CIMA, IDISNA, Pamplona, Spain;
(20) Hospital General Universitario Morales Meseguer, Murcia, Spain;
(21) Wurzburg University Medical Center, Wurzburg, Germany;
(22) Universitatsklinikum, Medizinsche Klinik und Poliklinik I, Dresden, Germany;
(23) Complejo Asistencial Universitario de Salamanca (IBSAL), Centro Investigacion del Cancer-IBMCC (USAL-CSIC), Salamanca, Spain;
(24) Myeloma Institute for Research and Therapy, University of Arkansas Medical School, Little Rock, AR, United States;
(25) Celgene International Sarl, Boudry, Switzerland;
(26) Celgene Corporation, Summit, NJ, United States;
(27) University Hospital Hotel‐Dieu, Nantes, France.
Patients with relapsed and/or refractory multiple myeloma (RRMM) have poor prognosis. The STRATUSTM 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 pts 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.
CITATION Blood. 2016 May 25. pii: blood-2016-02-700872