TY - JOUR
T1 - Pomalidomide, dexamethasone, and daratumumab immediately after lenalidomide-based treatment in patients with multiple myeloma
T2 - updated efficacy, safety, and health-related quality of life results from the phase 2 MM-014 trial
AU - Bahlis, Nizar J.
AU - Siegel, David S.
AU - Schiller, Gary J.
AU - Samaras, Christy
AU - Sebag, Michael
AU - Berdeja, Jesus
AU - Ganguly, Siddhartha
AU - Matous, Jeffrey
AU - Song, Kevin
AU - Seet, Christopher S.
AU - Acosta-Rivera, Mirelis
AU - Bar, Michael
AU - Quick, Donald
AU - Anz, Bertrand
AU - Fonseca, Gustavo
AU - Chung, Weiyuan
AU - Lee, Kim
AU - Mouro, Jorge
AU - Agarwal, Amit
AU - Reece, Donna
N1 - Funding Information:
This study was sponsored by Celgene, a Bristol-Myers Squibb Company. The authors thank Faiza Zafar for her support and contributions to the study while employed at Celgene, a Bristol-Myers Squibb Company, and Mihaela Marina of MediTech Media, Ltd, for medical writing assistance in the preparation of this manuscript, which was sponsored by Bristol Myers Squibb.
Publisher Copyright:
© 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2022
Y1 - 2022
N2 - Patients with relapsed/refractory multiple myeloma (RRMM) need proven subsequent therapies after early-line lenalidomide treatment failure. The phase 2 MM-014 trial (NCT01946477) investigated pomalidomide, dexamethasone, and daratumumab after 1 to 2 prior treatment lines (62.5%, 1 prior line) in patients with RRMM and prior lenalidomide (75.0%, lenalidomide refractory). With a median follow-up of 28.4 months, overall response rate was 77.7% (52.7% achieved very good partial response or better) and median progression-free survival was 30.8 months. For patients with lenalidomide-refractory disease, these outcomes were 76.2%, 47.6%, and 23.7 months, respectively. No new safety signals were observed; 64.3% experienced grade 3/4 neutropenia. Health-related quality of life was preserved or trended toward improvement through 12 treatment cycles. Pomalidomide, dexamethasone, and daratumumab given immediately after early-line lenalidomide-based treatment continues to demonstrate safety and efficacy, supporting pomalidomide-dexamethasone as a foundation of combination therapy in RRMM and providing evidence that the immunomodulatory agent class delivers benefit after lenalidomide treatment failure.
AB - Patients with relapsed/refractory multiple myeloma (RRMM) need proven subsequent therapies after early-line lenalidomide treatment failure. The phase 2 MM-014 trial (NCT01946477) investigated pomalidomide, dexamethasone, and daratumumab after 1 to 2 prior treatment lines (62.5%, 1 prior line) in patients with RRMM and prior lenalidomide (75.0%, lenalidomide refractory). With a median follow-up of 28.4 months, overall response rate was 77.7% (52.7% achieved very good partial response or better) and median progression-free survival was 30.8 months. For patients with lenalidomide-refractory disease, these outcomes were 76.2%, 47.6%, and 23.7 months, respectively. No new safety signals were observed; 64.3% experienced grade 3/4 neutropenia. Health-related quality of life was preserved or trended toward improvement through 12 treatment cycles. Pomalidomide, dexamethasone, and daratumumab given immediately after early-line lenalidomide-based treatment continues to demonstrate safety and efficacy, supporting pomalidomide-dexamethasone as a foundation of combination therapy in RRMM and providing evidence that the immunomodulatory agent class delivers benefit after lenalidomide treatment failure.
KW - Pomalidomide
KW - daratumumab
KW - lenalidomide
KW - multiple myeloma
KW - refractory
KW - Dexamethasone
KW - Lenalidomide
KW - Humans
KW - Antibodies, Monoclonal
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Multiple Myeloma/diagnosis
KW - Thalidomide/analogs & derivatives
KW - Neoplasm Recurrence, Local/drug therapy
KW - Quality of Life
KW - Neoplasms, Plasma Cell
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UR - http://www.scopus.com/inward/citedby.url?scp=85124914662&partnerID=8YFLogxK
U2 - 10.1080/10428194.2022.2030477
DO - 10.1080/10428194.2022.2030477
M3 - Article
C2 - 35133221
AN - SCOPUS:85124914662
SN - 1042-8194
VL - 63
SP - 1407
EP - 1417
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
IS - 6
ER -