Study Comparing Iberdomide to Monitoring After CAR-T Therapy for Multiple Myeloma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06179888

Provider View

This clinical trial is exploring whether taking the drug iberdomide after receiving CAR-T therapy can help patients with multiple myeloma live longer compared to just monitoring the disease without additional treatment.

Patient Parameters

Program Overview

The purpose of this study is to see if iberdomide, a drug that boosts the immune system, can help control multiple myeloma for a longer time after patients have received CAR-T therapy. The usual approach after CAR-T therapy is to monitor the disease without giving any more myeloma medications. Researchers want to find out if iberdomide can improve survival and keep the cancer under control better than just monitoring.

Description

This study is divided into two main parts: a safety run-in and a randomized phase II trial.

In the safety run-in, researchers will determine the safe dose of iberdomide to use after CAR-T therapy. In the randomized phase II trial, patients will be divided into two groups. One group will receive iberdomide, and the other group will be monitored without additional treatment. The main goal is to see if iberdomide can help patients live longer without the cancer getting worse.

Secondary goals include evaluating how well iberdomide works in reducing cancer cells, improving overall survival, and understanding the safety of the drug. Researchers will also study how iberdomide affects the immune system and the persistence of CAR-T cells in the body.

Patients in the study will have regular clinic visits, blood tests, and imaging scans to monitor their health and the status of their cancer. After completing the study treatment, patients will be followed up every few months for up to four years.

Eligibility Criteria

Inclusion Criteria

  • Must be pre-registered to submit bone marrow and blood samples.
  • Must have a confirmed diagnosis of multiple myeloma and be in stable condition or better after CAR-T therapy.
  • Must have received CAR-T therapy within 80-110 days before joining the study.
  • Must have had at least four previous treatments for multiple myeloma.
  • Must be 18 years or older.
  • Must have a good performance status, meaning they can carry out daily activities with minimal assistance.
  • Must have adequate blood cell counts and organ function.
  • Women of childbearing potential must use effective birth control and have a negative pregnancy test before starting the study.
  • Men must agree to use contraception during the study and for 28 days after.
  • Must not have any active infections or allergies to iberdomide.
  • Must not have received other multiple myeloma treatments since CAR-T therapy, except for short-term steroids for managing side effects.
  • Must not be taking certain medications that interact with iberdomide, unless they can switch to a different medication.

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