Relapsed or Refractory Multiple Myeloma Clinical Trial
Official title:
A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
This was a multicenter, open-label, single-arm phase 3B study of the combination
lenalidomide plus pulse high-dose dexamethasone.
This study (CC-5013-MM-019) was set up and executed primarily as an expanded access program
in Germany.
Screening procedures were to take place within 28 days prior to Cycle 1 Day 1 (baseline)
with the exception of hematology assessments that were to be performed within 14 days prior
to Cycle 1 Day 1. Randomization, blinding, and stratification were not applied in this
open-label single-arm study.
Eligible subjects given open-label treatment and received treatment with lenalidomide plus
high-dose dexamethasone in 28-day cycles.
Lenalidomide (hard capsules) was to be administered orally (PO) at a dose of 25 mg daily
(QD) for the first 21 days of each 28-day cycle. According to the protocol, accrual of
subjects to the study was to be terminated within 2 months of commercial availability of
lenalidomide for this indication in Germany.
Upon discontinuation from study, minimal information was collected in order to identify when
disease progressed.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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