New Trial Doses STAR-LLD in Patients With Multiple Myeloma

The first patient has received treatment with STAR-LLD in a clinical trial.

The first patient has been dosed in a clinical phase 1b trial is testing low dose Revlimid (lenalidomide), known as STAR-LLD, to treat patients with multiple myeloma, according to Starton Therapeutics, the manufactuer of the drug.

STAR-LLD, a delivery method Revlimid, is being researched and developed to improve ways of treating specific blood cancers, such as multiple myeloma and chronic lymphocytic leukemia (CLL).

Within this study, the treatment of STAR-LLD will be administered in the secondline setting in six patients who are unable to receive transplants. These patients will receive STAR-LLD every day within a 28-day cycle, while also taking dexamethasone and Velcade (bortezomib).

Side effects, immune markers and efficiency will be analyzed within these patients. The study will also measure how well the treatment works when it comes to response rates, duration of response (length of time that tumor responds to treatment without growing/changing), progression-free survival (time from random assignment in a trial to disease progression or death) and minimal residual disease changes (cells left in the body post-treatment).

“We are entering the development stage, in which we expect to achieve the safety and tolerability improvement profile as well signals of efficacy for our proprietary continuous delivery of (Revlimid). We will enable the patient outcomes and quality of life improvements for which we founded Starton,” Pedro Lichtinger, chairman and CEO of Starton Therapeutics, said in a press release. “We are excited to evaluate the potential of STAR-LLD in this trial as a critical step towards delivering on our pipeline of transformative therapies using our continuous delivery technology.”

Dr. Nash Gabrail, the study’s principal investigator, discussed the possible improvements that could come with STAR-LLD treatment.

“Revlimid is an indispensable drug in treating multiple myeloma. Unfortunately, many times patients do not tolerate the side effects associated with oral dosing. I believe the ability to target the precise therapeutic blood levels with continuous administration of the drug may allow an improvement in the therapeutic index of lenalidomide and allow patients to stay on therapy longer,” he said.

This could be a potential achievement for patients being treated for multiple myeloma, discussed Dr. Jamie Oliver, Starton’s chief medical officer.

“(Revlimid) has been an effective immunomodulatory drug in hematologic malignancies for years. However, adverse events have limited its use in certain patient settings, depriving patients of the full benefits the medicine can offer. We believe STAR-LLD may be able to expand the use of lenalidomide where the oral form is not used today,” noted Oliver.

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