Study on Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone for Newly-Diagnosed Multiple Myeloma Patients

Sponsor: University of Miami

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04268498

Provider View

This clinical trial is exploring whether a combination of drugs, including Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone, can be a safer and more effective treatment for newly diagnosed multiple myeloma compared to the current standard treatment.

Patient Parameters

Program Overview

The purpose of this study is to determine if using a combination of drugs—Carfilzomib, Lenalidomide, and Dexamethasone (KRD), with or without Daratumumab (KRD+DARA)—is a better way to manage multiple myeloma than the standard treatment, which includes Lenalidomide, Bortezomib, and Dexamethasone (VRD).

Description

This study is designed to find out if a new combination of medications can improve treatment outcomes for patients with newly diagnosed multiple myeloma. The study will compare two groups: one receiving Carfilzomib, Lenalidomide, and Dexamethasone (KRD), and the other receiving the same combination plus Daratumumab (KRD+DARA). The goal is to see if these combinations are safer and more effective than the current standard treatment, which includes Lenalidomide, Bortezomib, and Dexamethasone (VRD).

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with multiple myeloma, confirmed by lab tests, and have measurable disease.
  • Show signs of organ damage or specific myeloma-related events, such as high calcium levels, anemia, bone damage, or a high percentage of plasma cells in the bone marrow.
  • Kidney function must be adequate, with a creatinine clearance of at least 60 ml/min.
  • Aged 18 to 75 years old.
  • Good overall health with a performance status score of 0 to 2.
  • Sufficient blood cell counts and liver function.
  • Able to tolerate blood clot prevention medications like aspirin or other anticoagulants.
  • Must be registered in a safety monitoring program and agree to follow its requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control methods. Men must agree to use condoms during sexual activity.

Exclusion Criteria

  • Have received more than one cycle of prior treatment for multiple myeloma.
  • Have been treated with certain drugs like Daratumumab or other anti-CD38 therapies, unless part of a re-treatment study.
  • Have plasma cell leukemia, POEMS syndrome, or amyloidosis.
  • Have severe lung conditions like COPD with low lung function or uncontrolled asthma.
  • Pregnant or breastfeeding women.
  • Have uncontrolled high blood pressure or diabetes.
  • Have active hepatitis B or C, or HIV infection.
  • Have significant heart disease or recent heart attack.
  • Have severe nerve damage or neuropathy.
  • Have had major surgery within the last three weeks.

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