Study on Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for Treating Relapsed Multiple Myeloma

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT06785415

Provider View

This clinical trial is testing a combination of four drugs to see if they are safe and effective in treating multiple myeloma that has returned after previous treatment. The study aims to find the best dose and understand how well the treatment works in shrinking the cancer.

Patient Parameters

Program Overview

This study is exploring a new treatment for multiple myeloma, a type of blood cancer, that has come back after initial improvement. The treatment combines four drugs: iberdomide, daratumumab, elotuzumab, and dexamethasone. Iberdomide may help the immune system fight cancer, while daratumumab and elotuzumab are antibodies that target cancer cells. Dexamethasone is used to reduce inflammation and manage side effects. The study will test the safety and effectiveness of this combination to see if it can help control the cancer.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest dose of the drug combination. In Phase II, they will evaluate how well the treatment works in reducing cancer in patients with relapsed multiple myeloma.

Participants will take iberdomide by mouth daily for 21 days in each 28-day cycle. Daratumumab will be given as an injection under the skin, and elotuzumab will be administered through an IV. Dexamethasone will be taken by mouth. The treatment cycles will repeat every 28 days for up to 36 cycles, as long as the cancer does not worsen and side effects are manageable.

Patients will undergo various tests, including bone marrow biopsies and imaging scans, to monitor the cancer's response to the treatment. After completing the study treatment, participants will have follow-up visits to check their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have relapsed multiple myeloma with no more than three previous treatments.
  • Have received certain types of previous treatments for multiple myeloma.
  • Have measurable disease.
  • Be in good overall health with an ECOG performance status of 0, 1, or 2.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Men must agree to use contraception and not donate sperm during the study and for a period after.
  • Willing to provide informed consent and follow study requirements, including providing bone marrow samples for research.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • People unwilling to use adequate contraception.
  • Currently receiving other cancer treatments.
  • Have certain infections like HIV or active hepatitis.
  • Have significant heart problems or uncontrolled asthma.
  • Have allergies to study medications.
  • Have had major surgery recently.
  • Have other serious medical or psychiatric conditions that could interfere with the study.
  • Have a history of severe allergic reactions to similar drugs.
  • Have certain other health conditions that could affect participation.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Rochester55905RochesterMinnesota

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