Study on Elotuzumab, Iberdomide, and Dexamethasone After Ide-Cel for Relapsed and Refractory Multiple Myeloma

Sponsor: Omar Nadeem, MD

Sponsor score: 0

ClinicalTrials ID:NCT06518551

Provider View

This clinical trial is testing a new combination of drugs, Elotuzumab, Iberdomide, and Dexamethasone, to see if they can help treat patients with multiple myeloma that has returned or not responded to previous treatments, including Ide-Cel.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well a combination of Elotuzumab, Iberdomide, and Dexamethasone works in patients with multiple myeloma that has come back or is not responding to treatment. Elotuzumab is already approved for treating multiple myeloma, while Iberdomide is still being studied. Participants will undergo various procedures, including blood tests, scans, and bone marrow biopsies, to monitor their health and the treatment's effectiveness. About 49 people are expected to participate in this study, which is supported by Bristol-Myers Squibb and Celgene.

Description

This study is in Phase I/II and is open-label, meaning both the researchers and participants know what treatment is being given. It is not randomized, so all participants will receive the same treatment. The study aims to see if the combination of Elotuzumab, Iberdomide, and Dexamethasone can help control multiple myeloma after treatment with Ide-Cel. Participants will have regular visits for treatment and monitoring, including blood and urine tests, scans, and other assessments to check their response to the therapy. The study is supported by Bristol-Myers Squibb and Celgene, who provide the study drugs and funding.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with multiple myeloma based on standard criteria.
  • Must have given written consent to participate in the study.
  • Previously treated with at least four different types of myeloma treatments, including specific drug types.
  • Must have received Ide-Cel treatment and shown at least a partial response within 90 days of infusion.
  • Must be in good general health with a performance status score of 2 or less.
  • Must meet specific blood test criteria, including adequate blood cell counts and organ function.
  • Must be 18 years or older.
  • Women of childbearing potential must have negative pregnancy tests and agree to use effective birth control during the study and for 28 days after the last dose.
  • Men must agree to use effective birth control during the study and for 28 days after the last dose.
  • All participants must agree not to donate blood or sperm during the study and for 28 days after the last dose.

Exclusion Criteria

  • Previous treatment with Iberdomide.
  • Participation in other clinical trials within 30 days before starting this study.
  • Diagnosed with another cancer within the last 3 years, except for certain skin cancers or low-risk prostate cancer.
  • Known involvement of the central nervous system by cancer.
  • Recent use of certain medications that affect liver enzymes or herbal supplements like St. John's wort.
  • Any medical or psychiatric condition that could interfere with the study.
  • Active graft versus host disease after stem cell transplant.
  • Recent major surgery or radiation therapy within 14 days before starting the study.
  • Uncontrolled heart conditions or recent heart attack.
  • Recent use of certain cancer treatments or vaccines.
  • Active infections requiring treatment within 7 days before starting the study.
  • Positive for active viral infections like HIV or hepatitis B or C.
  • Pregnant or breastfeeding women.
  • Known allergies to study drugs or their components.
  • Inability to tolerate blood clot prevention treatments.
  • Not fully recovered from previous chemotherapy side effects.

Locations

FACILITYZIPCITYSTATE
Brigham and Women's Hospital02115BostonMassachusetts
Beth Israel Deaconess Medical Center02215BostonMassachusetts
Dana Farber Cancer Institute02215BostonMassachusetts

Get This Program In Your Inbox

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