Lenalidomide maintenance for high-risk multiple myeloma after allogeneic hematopoietic cell transplantation.
Allogeneic hematopoietic cell transplantation (alloHCT) with reduced-intensity conditioning is an appealing option for patients with high-risk multiple myeloma (MM). However, progression after alloHCT remains a challenge. Maintenance therapy after alloHCT may offer additional disease control and allow time for a graft-versus-myeloma effect. The primary objective of this clinical trial was to determine the tolerability and safety profile of maintenance lenalidomide (LEN) given on days 1 to 21 of 28 days cycles, with intrapatient dose escalation during 12 months/cycles after alloHCT. Thirty alloHCT recipients (median age, 54 years) with high-risk MM were enrolled at 8 centers between 2009 and 2012. The median time from alloHCT to LEN initiation was 96 days (range, 66 to 171 days). Eleven patients (37%) completed maintenance and 10 mg daily was the most commonly delivered dose (44%). Most common reasons for discontinuation were acute graft-versus-host disease (GVHD) (37%) and disease progression (37%). Cumulative incidence of grades III to IV acute GVHD from time of initiation of LEN was 17%. Outcomes at 18 months after initiation of maintenance were MM progression, 28%; transplantation-related mortality, 11%; and progression-free and overall survival, 63% and 78%, respectively. The use of LEN after alloHCT is feasible at lower doses, although it is associated with a 38% incidence of acute GVHD. Survival outcomes observed in this high-risk MM population warrant further study of this approach.
Department of Blood and Marrow Transplantation, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. Electronic address: melissa.alsina@moffitt.org.
Melissa
M
Alsina
Division of Hematology, University of Washington School of Medicine/Fred Hutchinson Cancer Research Center, Seattle, Washington.
Pamela S
PS
Becker
Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, New York.
Xiaobo
X
Zhong
Prospective Research, Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.
Alexia
A
Adams
Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, Wisconsin.
Parameswaran
P
Hari
Blood and Marrow Stem Cell Transplantation Division, John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey.
Scott
S
Rowley
Blood and Marrow Stem Cell Transplant Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.
Edward A
EA
Stadtmauer
Multiple Myeloma and Blood and Marrow Stem Cell Transplantation Divisions, John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey.
David H
DH
Vesole
Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, Wisconsin.
Brent
B
Logan
Division of Hematology, Oncology and Transplantation, Department of Medicine, University of Minnesota Medical Center, Minneapolis, Minnesota.
Daniel
D
Weisdorf
Division of Cancer Medicine, Department of Stem Cell Transplantation, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Muzaffar
M
Qazilbash
Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, Duarte, California.
Leslie L
LL
Popplewell
Division of Hematology, Oncology and Transplantation, Department of Medicine, University of Minnesota Medical Center, Minneapolis, Minnesota.
Brian
B
McClune
Division of Hematology, University of Washington School of Medicine/Fred Hutchinson Cancer Research Center, Seattle, Washington.
William
W
Bensinger
Department of Blood and Marrow Transplantation, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
Marcie
M
Riches
Division of Hematologic Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
Sergio A
SA
Giralt
Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, Wisconsin.
Marcelo C
MC
Pasquini
D000293:Adolescent; D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D011446:Prospective Studies; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019172:Transplantation Conditioning / Q000009:adverse effects*; D014184:Transplantation, Homologous / Q000009:adverse effects*; D055815:Young Adult
D020533:Angiogenesis Inhibitors; D013792:Thalidomide; D000077269:Lenalidomide
Allogeneic transplantation; Lenalidomide; Multiple myeloma