This study is being carried out to examine whether KRD including carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone (Decadron) with or without daratumumab (Darzalex) is safe and effective in the treatment of multiple myeloma (MM). The main outcome to be measured is the measurable residual disease (MRD; disease left in the body after initial treatment). This study is being carried out in Sweden, and the United States.
MM is a form of cancer that originates from a type of white blood cell called a plasma cell. MM causes cancer cells to accumulate in the bone marrow where they crowd out healthy blood cells. The standard treatment for newly diagnosed MM is the VRD regimen including bortezomib (Velcade), lenalidomide, and dexamethasone. However, some patients may relapse after this treatment. Therefore, other regimens are needed for these patients.
Daratumumab is a type of immunotherapy. It kills myeloma cells or allows the immune system to kill them. KRD is a regimen that has shown promise in the treatment of MM.
This trial wants to compare the effectiveness of KRD with or without daratumumab with the standard VRD regimen in patients with newly diagnosed MM. The main outcome to be measured is the MRD.
Who are they looking for?
The trial is looking to recruit 462 patients with newly diagnosed, confirmed MM. Patients will be included if they have evidence of organ damage such as bone disease, high calcium levels, anemia. They must have adequate kidney and liver function and must agree to use effective birth control measures.
Patients cannot participate if they have received previous treatment for MM, if they have other conditions such as plasma cell leukemia, amyloidosis, HIV, hepatitis B or C. Female patients must not be pregnant or currently lactating. Patients with poor lung or heart function cannot participate.
How will it work
There are three groups in this trial. Group 1 will receive VRD treatment. Group 2 will receive KRD treatment. Group 3 will receive KRD plus daratumumab treatment.
The outcomes of MRD will be physician assessed and will be assessed over 32 weeks following treatment.