STAR-LLD

A Protocol to Assess the Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Administration of Low-dose Lenalidomide (STAR-LLD) for the Treatment of Multiple Myeloma (MM)

What's the purpose of the trial?

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). 

Trial status

Accepting patients

Phase
Phase 1/2
Enrollment
24
Last Updated
4 weeks ago

Participating Centers

There is one center participating in this trial. Enter a location below to view the distance.

Experimental Treatments

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  • Bortezomib Bortezomib is a kind of medication called a proteasome inhibitor that interferes with the growth and spread of cancer cells in the body. Bortezomib is used to treat multiple myeloma and mantle cell lymphoma.
  • Dexamethasone is a corticosteroid that prevents the release of substances in the body that cause inflammation, and is given in conjunction with some cancer treatments.
  • Lenalidomide is an oral immunomodulatory drug that may help the immune system kill cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow.

Arms / Cohorts

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Accepting patients

Arm 1: Lenalidomide 400 mcg/h

Accepting patients

Arm 2: Lenalidomide 300 mcg/h

Accepting patients

Arm 3: Lenalidomide 500 mcg/h

Published Results

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Starton Therapeutics Presents Positive Data from Phase 1b Study Evaluating STAR-LLD for the Treatment of Relapsed/Refractory Multiple Myeloma

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.

  • No patients experienced drug-related anemia, neutropenia, leukopenia, or thrombocytopenia greater than grade 2 in up to 12 cycles of therapy.
  • Non-hematologic toxicities did not exceed Grade 2
  • The PK/PD data minimized Cmax and lowered AUC while achieving biologically active doses and reducing toxicity
    • STAR-LLD pharmacokinetics produced median steady-state blood levels (Cmax) of 39 ng/mL (N=6) and were above the minimum target of 25 ng/mL.
  • All six patients receiving STAR-LLD achieved an objective response (1 CR and 5 PRs); one patient who achieved a partial response experienced a Grade 2 skin reaction during cycle 3 and withdrew from the study
  • Continuous treatment with STAR-LLD does not appear to significantly increase immune checkpoints associated with T cell exhaustion
  • Five patients are continuing treatment per protocol with a median PFS of > 10 months
3 months ago Read more

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