Study on ERd Combination Treatment for Newly Diagnosed Multiple Myeloma

Sponsor: University of Miami

Sponsor score: 40

ClinicalTrials ID:NCT06997081

This clinical trial is exploring the effects of a new treatment combination using Elranatamab, Lenalidomide, and Dexamethasone for patients who have been newly diagnosed with Multiple Myeloma.

Patient Parameters

Program Overview

The purpose of this study is to find out how well a combination of three drugs—Elranatamab, Lenalidomide, and Dexamethasone—works in treating people who have recently been diagnosed with Multiple Myeloma, a type of blood cancer.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older who have been newly diagnosed with Multiple Myeloma.
  • Must have measurable disease based on specific medical tests within the last 4 to 8 weeks.
  • Evidence of organ damage or specific myeloma-related events, such as high calcium levels, anemia, bone damage, or abnormal plasma cells in the bone marrow.
  • Must have good overall health with a performance status score of 0 to 2.
  • Adequate organ and bone marrow function as shown by specific blood tests.
  • Willing to participate in a safety program for Lenalidomide.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
  • Men must agree to use condoms during the study and for a period after the last dose of treatment.
  • Must be able to understand and sign a consent form.
  • Must be willing to follow study guidelines and lifestyle restrictions.

Exclusion Criteria

  • Have received more than one cycle of prior treatment for Multiple Myeloma.
  • Have active central nervous system involvement or signs of myeloma in the brain or spinal cord.
  • Have had major surgery within 14 days before joining the study.
  • Have a history of severe nerve damage.
  • Are currently receiving other investigational treatments for Multiple Myeloma.
  • Have received a live vaccine within 4 weeks before starting the study treatment.
  • Have certain infections like active hepatitis B or C, or HIV with specific conditions.
  • Have severe lung diseases or uncontrolled asthma.
  • Have a history of severe allergic reactions to similar drugs.
  • Women who are pregnant or breastfeeding.
  • Men planning to father a child during or shortly after the study.
  • Have certain heart conditions or uncontrolled illnesses that could interfere with the study.
  • Have had another active cancer within the last 3 years, except for certain skin cancers or very early-stage cancers.

Locations

FACILITYZIPCITYSTATE
University of Miami33136MiamiFlorida

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