Study on the Safety, Effectiveness, and Drug Behavior of Continuous Subcutaneous Lenalidomide in Multiple Myeloma

Sponsor: Starton Therapeutics, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06087653

Provider View

This clinical trial is testing a new way to give the drug lenalidomide continuously under the skin, along with other medications, to see if it is safe and effective for treating multiple myeloma, a type of blood cancer.

Patient Parameters

Program Overview

The main goal of this study is to find out if giving lenalidomide continuously under the skin, along with dexamethasone and a proteasome inhibitor, is safe and well-tolerated in patients with multiple myeloma. Researchers will also look at how this treatment affects the immune system, how the drug behaves in the body, and how it impacts cancer markers. They will evaluate the treatment's effectiveness by looking at response rates, how long patients stay free from disease progression, and how long the response lasts. Additionally, the study will explore how the treatment affects patients' symptoms and quality of life.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Cannot have had a stem cell transplant.
  • Must test negative for COVID-19.
  • Must have a prior diagnosis of multiple myeloma with measurable disease after first-line therapy.
  • Must be planning to receive lenalidomide, dexamethasone, and a proteasome inhibitor as second-line or later treatment.
  • Must be sensitive to proteasome inhibitors, meaning the disease did not progress for more than 6 months after stopping a proteasome inhibitor or never received one before.
  • Must have disease progression on the most recent therapy.
  • Must have a performance status score of 2 or less, or 3 if due to bone pain from multiple myeloma.
  • Must agree to follow a pregnancy prevention plan if of childbearing potential, including regular pregnancy tests and using two forms of birth control.
  • Must be able to take blood clot prevention medication.
  • Must meet specific blood and organ function criteria during screening.
  • Must be able to receive treatment at home with the help of a trained caregiver.

Exclusion Criteria

  • Cannot be pregnant or breastfeeding.
  • Cannot have had a stem cell transplant.
  • Cannot have had a blood clot in the past year.
  • Cannot have active hepatitis B or C, or HIV while on treatment for these infections.
  • Cannot be taking any experimental treatments for multiple myeloma within 28 days before starting the study.
  • Cannot have previously taken lenalidomide without achieving a response.
  • Cannot have stopped a previous treatment due to lenalidomide side effects.
  • Cannot be using certain medications that interact with the study drugs.
  • Cannot have certain other blood disorders or active infections.
  • Cannot have had another cancer in the past 3 years, except for certain skin cancers or other low-risk cancers.
  • Cannot have had major surgery or radiation therapy within 4 weeks before starting the study, except for short radiation for bone pain within 7 days.
  • Cannot have any condition that would prevent understanding or following the study procedures, or pose a risk to safety.

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