Study on Carfilzomib, Iberdomide, and Dexamethasone for Transplant Eligible Multiple Myeloma

Sponsor: Hackensack Meridian Health

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05199311

Provider View

This clinical trial is testing a new combination of drugs, Carfilzomib, Iberdomide, and Dexamethasone, for patients with newly diagnosed multiple myeloma who are eligible for a stem cell transplant. The study aims to determine the safety and effectiveness of this treatment.

Patient Parameters

Program Overview

This study is exploring a new treatment combination for patients with newly diagnosed multiple myeloma who are eligible for a stem cell transplant. The treatment includes three drugs: Carfilzomib, Iberdomide, and Dexamethasone. The study will start with a small group of patients to determine the safest dose, and then expand to include more participants. Patients will receive the treatment for up to four cycles, each lasting 28 days, before undergoing a stem cell transplant. Participants will be monitored every three months for up to two years to track their progress and any side effects.

Description

This clinical trial is designed to test a new combination of drugs for treating multiple myeloma in patients who are eligible for a stem cell transplant. The treatment includes Carfilzomib, Iberdomide, and Dexamethasone, and is referred to as the KID regimen.

The study will begin with a phase where the dose of Iberdomide is gradually increased to find the safest and most effective dose. Initially, 10 patients will receive a lower dose, and if it is safe, the dose will be increased for the next group of 10 patients. After confirming safety, the remaining patients will receive the highest planned dose.

Participants will receive the treatment for up to four cycles, each lasting 28 days, before undergoing a stem cell transplant. After the treatment, patients will be followed up every three months for up to two years to monitor their health and any signs of disease progression.

The study aims to provide valuable information on the safety and effectiveness of this new treatment combination for multiple myeloma.

Eligibility Criteria

Inclusion Criteria

  • Have a new diagnosis of multiple myeloma.
  • Be eligible for a stem cell transplant.
  • Have not received more than one cycle of prior treatment for multiple myeloma.
  • Be 18 years or older.
  • Be able to understand and sign a consent form.
  • Have measurable disease based on specific medical tests.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Women of childbearing potential must have negative pregnancy tests and agree to use effective contraception.
  • Men must agree to use condoms during sexual contact and refrain from donating sperm during the study.
  • Agree to follow all study requirements, including the Pregnancy Prevention Program.

Exclusion Criteria

  • Have any significant medical condition or psychiatric illness that would prevent participation.
  • Have nonsecretory multiple myeloma or certain other blood disorders.
  • Have certain abnormal blood test results, such as low blood cell counts or high calcium levels.
  • Have serious kidney problems or require dialysis.
  • Have a history of severe allergic reactions to similar drugs.
  • Have received certain treatments or medications recently, such as plasmapheresis or investigational drugs.
  • Have uncontrolled heart conditions or recent heart events.
  • Have active infections like HIV or hepatitis.
  • Be pregnant or breastfeeding, or unwilling to use contraception.
  • Have uncontrolled high blood pressure or diabetes.

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