Assess the safety and tolerability of low-dose lenalidomide administered by continuous subcutaneous (SC) infusion (STAR-LLD) in combination with dexamethasone and a proteasome inhibitor (PI).
This trial is currently open and accepting patients.
Primary Objective
Secondary Objectives
Exploratory Objective
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Inclusion Criteria:
Documented measurable disease following first line therapy defined as:
The following laboratory results must be met during screening:
The following criteria must be met within 72 hours prior to first administration of continuous infusion STAR-LLD:
Exclusion Criteria:
Phase 1/2
Enrollment: 24 patients (estimated)
View MoreApril 25, 2025
Six relapsed/refractory MM patients were enrolled from two U.S. community-based investigational sites in the Phase 1b study. Median age was 73, male to female ratio 1/1, Caucasian 100%, and median lines of previous therapy were 2 (range 1-7). Two patients were refractory and four were relapsed to their prior treatment. Four patients were previously exposed to lenalidomide, one of which was discontinued from a prior regimen because of severe fatigue, and all six had received prior bortezomib. Patients received 3-12 cycles of study therapy.
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