Study Comparing Elranatamab and Daratumumab with RVd Lite for Newly Diagnosed Multiple Myeloma Patients Not Eligible for Transplant

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07247097

Provider View

This clinical trial is comparing two treatment combinations for patients with newly diagnosed multiple myeloma who are not eligible for a transplant. The study aims to determine which combination is more effective and safer.

Patient Parameters

Program Overview

The ELDORADO study is testing two different treatment combinations for patients with newly diagnosed multiple myeloma who cannot have a transplant. One group will receive elranatamab with lenalidomide, bortezomib, and dexamethasone, while the other group will receive daratumumab with the same drugs. The study will involve about 160 patients and will last for 24 treatment cycles. Researchers will monitor patients for five years to see how well the treatments work and if there are any side effects. The study is supported by Pfizer, Inc., which provides the drug elranatamab and funding for the research.

Description

The ELDORADO trial is a phase 2 study involving about 160 patients with newly diagnosed multiple myeloma who are not eligible for a transplant. The study compares two treatment combinations: one with elranatamab and the other with daratumumab, both combined with lenalidomide, bortezomib, and dexamethasone. Patients will receive treatment for 24 cycles, and some may stop treatment early if they meet certain criteria. The study will follow patients for five years, mostly through reviewing their medical records. Elranatamab is a bispecific antibody that helps the immune system attack cancer cells, while daratumumab targets a protein on cancer cells to help the immune system destroy them. Lenalidomide, bortezomib, and dexamethasone are drugs that help control the immune system and stress cancer cells, leading to their destruction. The U.S. FDA has not yet approved these combinations for treating any disease.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old.
  • Newly diagnosed with multiple myeloma, with specific criteria such as high levels of certain proteins or bone lesions.
  • Must have measurable disease based on specific tests.
  • Not eligible for high-dose melphalan and stem cell transplant.
  • ECOG performance status of 0-2, meaning fully active or with some restrictions.
  • Adequate blood counts and organ function based on specific tests.
  • Must agree to use blood clot prevention methods.
  • Women of childbearing potential must have negative pregnancy tests and agree to use contraception.
  • Men must follow specific safety guidelines for lenalidomide.
  • Willing to undergo repeat bone marrow biopsies.
  • Able to understand and sign informed consent.

Exclusion Criteria

  • Previous or current treatment for any plasma cell disorder, except emergency use of certain steroids.
  • Pregnant or breastfeeding women.
  • Plans to father a child during or shortly after the study.
  • History of other cancers unless treated and disease-free for at least 3 years, with some exceptions.
  • Certain blood disorders or infections like HIV or hepatitis.
  • Significant heart, lung, or other health issues that could interfere with the study.
  • Recent major surgery or participation in another clinical trial.
  • Recent vaccination with live vaccines.

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