Study on ON 123300 (Narazaciclib) and Dexamethasone for Patients with Relapsed or Hard-to-Treat Multiple Myeloma

Sponsor: Adriana Rossi

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06351644

Provider View

This clinical trial is testing a new treatment using ON 123300 (Narazaciclib) combined with dexamethasone to see if it is safe and effective for patients with multiple myeloma that has returned or is not responding to previous treatments.

Patient Parameters

Program Overview

Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow. This study is exploring a new drug, ON 123300 (Narazaciclib), which targets specific proteins involved in cancer cell growth. The trial aims to test the safety and effectiveness of this drug when used with dexamethasone in patients whose multiple myeloma has come back or is not responding to other treatments.

Description

ON 123300 (Narazaciclib) is a new drug that targets certain proteins in cancer cells, helping to stop their growth and eventually kill them. It works by interfering with the cell cycle, which is the process cells go through to divide and grow. This drug is being tested for its ability to treat various cancers, including multiple myeloma, when used alone or with other cancer treatments.

In this study, patients will take ON 123300 (Narazaciclib) along with dexamethasone, a steroid that helps reduce inflammation and can enhance the effects of cancer treatments. The trial will monitor how well the treatment works and any side effects that occur. Patients will continue the treatment as long as it is effective and they can tolerate it, for up to two years.

The study is open to patients who have tried at least two other treatments for multiple myeloma, including specific types of drugs, and whose cancer has either returned or not responded to these treatments. Participants must be able to swallow pills and have no active infections or other serious health conditions that could interfere with the study.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have multiple myeloma that has returned or not responded to at least two previous treatments, including specific drugs like proteasome inhibitors, immunomodulatory drugs, and CD38-targeting antibodies.
  • Must be able to provide written consent to participate.
  • Must have a performance status that allows for daily activities with some limitations.
  • Must have measurable disease based on specific medical tests.
  • Must be able to swallow and absorb oral medication.
  • Must have stopped previous cancer treatments at least 14 days before starting the study.
  • Must have adequate organ function based on specific blood tests.
  • Must not have active infections like HIV, Hepatitis B, or C, unless well-controlled.
  • Must agree to use effective contraception during the study and for 90 days after the last dose if of childbearing potential.

Exclusion Criteria

  • Cannot have active plasma cell leukemia or other specific blood disorders.
  • Cannot have had a stem cell transplant or other cellular therapy within 60 days.
  • Cannot have severe heart conditions or recent heart attacks.
  • Cannot have had a stroke or seizure within 6 months.
  • Cannot have uncontrolled infections or other serious health conditions.
  • Cannot be pregnant or breastfeeding.
  • Cannot have a history of alcohol or drug abuse.
  • Cannot have other cancers unless they have been in remission for a specified time.
  • Cannot be taking certain medications that interfere with the study drugs.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.