Study of Daratumumab Combined With Carfilzomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04113018
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is being done because, despite major advances in therapy, MM is still considered an incurable disease. The purpose of this study is to determine the efficacy (how well it works) of the study treatment that combines the following drugs: daratumumab, carfilzomib, lenalidomide, dexamethasone in subjects who have a recent diagnosis of multiple myeloma (MM). Normal plasma (blood) cells are found in the bone marrow and are an important part of the immune system. MM is a cancer formed by malignant (cancerous) plasma cells. Daratumumab, one of the study drugs, is a man-made protein that works with your immune system by attaching itself to the cancerous cells. Once daratumumab attaches itself to these cells, it gets your body's immune system to attack and destroy the MM cells. Daratumumab has shown to be effective in subjects with MM when combined with medicines like bortezomib, or lenalidomide + dexamethasone.

Key Dates

Start date
Jan 10, 2020
Status verified
Jan 2026
Primary completion
Jun 28, 2023
Completion
Oct 31, 2027

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: KRd-Daratumumab
    Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab

Primary Outcome Measure

Number of Participants With Complete Response or Stringent Complete Response to Induction [ Time Frame: From enrollment to best response determined at the end of induction (8 28-day cycles); the median length of induction was 32 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Levine Cancer InstituteCharlotteNorth Carolina28204-

Find similar trials in Charlotte, NC

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Levine Cancer Institute· Charlotte, NC

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