The study will investigate the effects of carfilzomib (Kyprolis), pomalidomide (Pomalyst), and dexamethasone (Decadron) in multiple myeloma (MM). The main outcome that will be measured will be the percentage of patients who have no signs or symptoms of MM after treatment (completed response). This study is recruiting in Georgia, Unites States.
The details
There are many different treatments for MM. Different combinations have different effects on cancer and cause different side effects. Therefore it is important to investigate the effects of different combinations of treatments for MM.
This study is evaluating the effectiveness of carfilzomib, pomalidomide, and dexamethasone combination for MM. The main outcome that will be measured will be completed response 2 years after treatment.
Who are they looking for?
This study will recruit 34 participants. Individuals must have undergone a stem cell transplant (cell transfer) within the year after they were diagnosed. Participants must have previously responded to treatment. To participate, individuals must not donate blood during the study or 90 days after. Females must not be pregnant while participating and must take preventative measures so as to not become pregnant during the study.
Those who did not respond after stem cell transplant cannot participate. Those who have experienced moderate nerve pain (neuropathy) in the 3 weeks before the study start will not be included. Those currently or previously treated with an anti-cancer drug for MM cannot participate. Patients with very low blood cell counts, with kidney or liver failure or who have uncontrolled heart disease, infections or another cancer cannot participate.
How will it work
All patients will receive the same treatment combination. Participants will be treated with carfilzomib on days 1, 2, 8, 9, 15, and 16. Pomalidomide will be given daily on days 1-21. Dexamethasone will be given on days 1, 2, 8, 9, 15, and 16. All treatments are given orally. Participants will receive this combination for 28 days and will receive up to 2 rounds of treatment. This will take place until the participant has reached completed response or has experienced severe side effects.
Following this treatment, in order to prevent the cancer returning (maintenance therapy), patients will receive carfilzomib on days 1, 8, and 15. Pomalidomide will be administered daily on days 1-21. Dexamethasone will be given daily on days 1, 8, and 15. This combination will be given every 28 days until the participant experiences cancer worsening or severe side-effects. Patients will be followed for up to two years.
