Study on Daratumumab Combined with Carfilzomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma

Sponsor: Wake Forest University Health Sciences

Sponsor score: 60

ClinicalTrials ID:NCT04113018

Provider View

This clinical trial is testing a combination of four drugs to see how well they work together in treating newly diagnosed multiple myeloma, a type of blood cancer. The study aims to find out if this treatment can effectively reduce cancer cells in the body.

Patient Parameters

Program Overview

This study is being conducted because multiple myeloma (MM) is still considered incurable despite advances in treatment. The goal is to test how well a combination of four drugs—daratumumab, carfilzomib, lenalidomide, and dexamethasone—works in people who have recently been diagnosed with MM. Daratumumab is a man-made protein that helps the immune system target and destroy cancerous cells. This study will help determine if this combination can effectively reduce cancer cells in patients with MM.

Description

This study involves a single group of participants and is conducted in two stages. It is an open-label Phase II trial, meaning both the researchers and participants know what treatment is being given. The main goal is to see how effective the treatment is after eight cycles of the drug combination, focusing on achieving a complete response or better in patients with newly diagnosed multiple myeloma (NDMM). After the initial treatment, participants will be evaluated for any remaining cancer cells, and further treatment will be based on these results. This trial will help gather information on using minimal residual disease (MRD) status to guide further treatment after the initial therapy.

Eligibility Criteria

Inclusion Criteria

  • Must provide written informed consent and authorization for the release of personal health information.
  • Must be 18 years or older.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have a confirmed diagnosis of newly diagnosed multiple myeloma (NDMM).
  • Must have measurable disease at the start of the study.
  • Must not have had more than one prior cycle of systemic therapy for MM.
  • Must have adequate organ function, including specific blood cell counts and kidney and liver function.
  • Must have adequate heart function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for three months after.
  • Men must agree to use condoms during the study and for three months after.
  • Must be able to understand and comply with study procedures.

Exclusion Criteria

  • Have any infection requiring systemic treatment.
  • Are pregnant or breastfeeding.
  • Have another active or progressive cancer requiring treatment.
  • Have non-secretory multiple myeloma.
  • Have cancer involvement in the central nervous system.
  • Have had a stroke with lasting effects.
  • Have severe lung disease or uncontrolled asthma.
  • Have POEMS syndrome.
  • Have had major surgery within two weeks before starting treatment.
  • Have used any investigational drugs or devices recently.
  • Have uncontrolled significant illnesses, including heart problems or psychiatric conditions.
  • Have allergies to any of the study drugs.
  • Are positive for hepatitis B, hepatitis C, or HIV.
  • Are considered frail if over 70 and ineligible for transplant.
  • Have previously been treated with daratumumab or similar therapies.
  • Have had recent radiation therapy, except for specific cases.

Locations

FACILITYZIPCITYSTATE
Levine Cancer Institute28204CharlotteNorth Carolina

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