Dataset Information

Lenalidomide maintenance for high-risk multiple myeloma after allogeneic hematopoietic cell transplantation.

ABSTRACT: 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.

SUBMITTER: Alsina M

PROVIDER: S-EPMC5036168 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Lenalidomide maintenance for high-risk multiple myeloma after allogeneic hematopoietic cell transplantation.

Alsina Melissa M Becker Pamela S PS Zhong Xiaobo X Adams Alexia A Hari Parameswaran P Rowley Scott S Stadtmauer Edward A EA Vesole David H DH Logan Brent B Weisdorf Daniel D Qazilbash Muzaffar M Popplewell Leslie L LL McClune Brian B Bensinger William W Riches Marcie M Giralt Sergio A SA Pasquini Marcelo C MC

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation 20140421 8

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 ...[more]

PMID: 24769014

Similar Datasets

Project description:Maintenance therapy with single-agent lenalidomide (Len) after autologous hematopoietic stem cell transplantation (autoHCT) for multiple myeloma (MM) is associated with improved progression-free survival (PFS). However, MM patients with high-risk chromosomal abnormalities (HRMMs) may need a more intense regimen. We hypothesized that adding another antimyeloma drug to Len maintenance would lead to improved outcomes. We conducted this retrospective single-center chart review analysis of adult HRMM patients who underwent autoHCT between 2008 and 2018, followed by Len-based maintenance therapy. High-risk cytogenetics were defined as del(17p), t(4;14), t(14;16), 1q21 gain or amplification by fluorescence in situ hybridization. We divided patients into those who received either single-agent Len maintenance (Len-only) or Len-based combinations (Len-combo). We compared nonrelapse mortality, day 100 and best post-transplantation responses, minimal residual disease status, PFS, and overall survival (OS) between the 2 groups. We also performed sensitivity analyses using inverse probability weights to correct for potential bias owing to nonrandomization of the 2 groups. A total of 231 patients with HRMM were included in our analysis, with a median age of 62.4 years (range, 33.5 to 79.9 years), and 55% were male. There were 153 patients in the Len-only group and 78 in the Len-combo group. Len-combo regimens were either doublets (Len with dexamethasone [dex] [n = 10], elotuzumab [n = 28], or ixazomib [n = 14]) or triplets (Len with bortezomib/dex [n = 10], ixazomib/dex [n = 10], or carfilzomib/dex [n = 6]). More patients in the Len-combo group had ≥2 high-risk cytogenetic abnormalities compared with the Len-only group (32% versus 12%: P < .001). The median duration of follow-up was 40.7 months in the Len-only group and 37.0 months in the Len-combo group. For all patients, the median PFS was 25.5 months, and the median OS was 82.6 months. There was no significant between-group difference in PFS (hazard ratio [HR] 1.01; 95% confidence interval [CI], .71-1.44; P = .94) or OS (HR, .84; 95% CI, .49 to 1.43; P = .52). However, for patients with high-risk cytogenetic abnormalities other than 1q+, there was a trend toward better PFS in the Len-combo group (HR, .59; 95% CI, .32 to 1.09; P = .09), but no difference in OS (HR, .79; 95% CI, .37 to 1.65; P = .53). In this single-center retrospective analysis, the use of Len-based combinations for post-transplantation maintenance was not associated with improved outcomes in HRMM patients; however, there was a trend toward improved PFS in patients with high-risk abnormalities other than 1q+.

Dataset Information

Lenalidomide maintenance for high-risk multiple myeloma after allogeneic hematopoietic cell transplantation.

Publications

Lenalidomide maintenance for high-risk multiple myeloma after allogeneic hematopoietic cell transplantation.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets