This study is looking for patients with newly diagnosed multiple myeloma (MM) to try different treatment regimens. The main outcome that will be measured is the number of patients who do not experience cancer worsening after treatment. This trial is recruiting in Chicago, Illinois, United States.
The details
There are several different therapies that are commonly used to treat MM. These include carfilzomib (Kyprolis), lenalidomide (Revlimid), dexamethasone (Decadron) andbortezomib (Velcade). Different combinations of these therapies have different effects on patients.
This study will compare the effects of carfilzomib, lenalidomide, and dexamethasone (KRD) with the effects of bortezomib, lenalidomide, and dexamethasone (VRD). The number of patients who do not experience cancer worsening in the 5 years after treatment will be the main outcome measured.
Who are they looking for?
This study will recruit 250 participants with MM. To be included patients must be newly diagnosed and must require chemotherapy. Patients who are or are not candidates for transplant may participate. All participants must use adequate contraception during the study. Patients must provide a bone marrow sample for testing at the entrance in the study. Patients must have adequate liver, kidney and bone marrow function tests.
Patients who are known to be unable to tolerate the study drugs will not be included. Those who have participated in another trial or have had surgery in the 3 weeks before the study starts cannot be included. Patients with amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia or IgM myeloma, brain disease, nerve disease, heart disease or severe diarrhea will not be accepted. Active infections requiring treatment, uncontrolled diabetes or lung disease are also exclusion criteria.
How will it work
Participants will be split into two groups. Group 1 will receive KRD in rounds of 28 days. Group 2 will receive VRD in rounds of 22 days. Carfilzomib will be given on day 1, 2, 15 and 16 for 24 treatment rounds. Lenalidomide will be given daily on days 1-22 for 24 rounds. Dexamethasone will be given on days 1, 8, 15 and 22 for 24 rounds. Bortezomib will be given on day 1, 4, 8 and 11 for 8 rounds.
Patients will be followed up for cancer growth or spread for up to 5 years.
