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

Sponsor: University of Miami

Sponsor score: 40

ClinicalTrials ID:NCT04268498

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.

Locations

FACILITYZIPCITYSTATE
University of Miami33136MiamiFlorida
Moffitt Cancer Center33612-9497TampaFlorida
Rush University Medical Center606012ChicagoIllinois
Roswell Park Comprehensive Cancer Center14203BuffaloNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Stony Brook University11794Stony BrookNew York
MD Anderson Cancer Center77030HoustonTexas
Huntsman Cancer Institue84113Salt Lake CityUtah

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