Multiple Myeloma

Dose/Schedule-Adjusted Rd-R Vs Continuous Rd for Elderly, Intermediate-Fit Patients with Newly Diagnosed Multiple Myeloma

Dose/Schedule-Adjusted Rd-R Vs Continuous Rd for Elderly, Intermediate-Fit Patients with Newly Diagnosed Multiple Myeloma

Background 
Lenalidomide dexamethasone, RD, is standard treatment for geriatric patients with multiple myeloma.

Purpose
The purpose of this study was to determine a dose/schedule adjusted combination of lenalidomide and dexamethasone followed by maintenance lenalidomide versus continuous lenalidomide dexamethasone in elderly/intermediate-fit patients with multiple myeloma.

Methods
In the randomized phase 3 clinical trial, dose/schedule Revlimid dexamethasone followed by maintenance at 10 mg/day without dexamethasone versus continuous Revlimid–dexamethasone in elderly/ intermediate-fit patients with newly diagnosed multiple myeloma were assessed.  The primary endpoint was event-free survival.  This was defined as progression or death from any cause, lenalidomide discontinuation or hematologic grade 4 adverse event, or nonhematologic grade 3 or 4 adverse events.  

There were 199 invaluable patients.  101 received Revlimid dexamethasone (Rd) followed by Revlimid (R) maintenance and 98 received continuous Revlimid–dexamethasone.  The median follow-up was 37 months.  The event-free survival was 10.4 versus 6.9 months, hazard ratio 0.70, 95% confidence interval 0.51–0.95, P = 0.02.  The median progression free survival, 20.2% 18.3 months, hazard ratio 0.78, 95% confidence interval, 0.55–1.10, P = 0.16.  The 3-year overall survival, 74% vs 63%, HR = 0.62, 95% CI, 0.37–1.03, P = 0.06 with Rd–R maintenance versus Rd continuous, respectively.

The rates of 1 or more nonhematologic grade 3 or 4 adverse events was 33 versus 43%, peak of 0.14 in the treatment arm versus the control arm with neutropenia at 21% versus 18%, respectively, infections 10% versus 12% respectively, and skin disorder 7% versus 3%.

Lenalidomide was discontinued for adverse events in 24 versus 30%.  Lenalidomide was reduced in 45% versus 62% of patients receiving Rd–R versus Rd, respectively.  The authors concluded “In intermediate fit patients, switching to a reduced dose of lenalidomide maintenance without dexamethasone after 9 Revlimid–dexamethasone cycles was feasible, with similar outcomes to standard continuous Revlimid–dexamethasone”

https://ashpublications.org/blood/article-abstract/137/22/3027/475576/Dose-schedule-adjusted-Rd-R-vs-continuous-Rd-for?redirectedFrom=fulltext

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