This study will investigate the effectiveness of a new combination of chemotherapies: clarithromycin (Biaxin), lenalidomide (Revlimid) and dexamethasone (Decadron), for newly diagnosed multiple myeloma (MM). The main outcome that will be measured is survival without cancer worsening. This trial will take place in New York, the U.S.
The details
Lenalidomide and dexamethasone are often used together to treat patients who have recently been diagnosed with MM. It is important to analyze the effects of different combinations of anti-cancer medicines.
This study will investigate if adding clarithromycin to lenalidomide and dexamethasone will make the combination more effective. The main result that will be monitored will be the duration before cancer worsening, 4 years after treatment.
Who are they looking for?
320 patients with newly diagnosed MM will be recruited. Participants must have never been treated for MM and must be able to take blood-thinners while participating. Patients must have adequate blood cell count and kidney and liver function tests.
Patients who have had cancer in the last five years other than skin, cervical, breast or low-medium risk prostate cancer cannot participate. Those who have problems swallowing tablets or who are allergic to any of the trial medicines cannot participate. Participants must also not have a bacterial or viral infection. Participants cannot have had a blood clot in the 4 weeks before enrolling in the trial.
How will it work
All treatments will be given in cycles of 28 days. All participants will receive lenalidomide and dexamethasone. Lenalidomide will be given every day for 21 days. Dexamethasone will be administered on day 1, 8, 15 and 22. Half of the participants will also receive clarithromycin twice a day for 28 days. Patients will be treated until they experience extreme side-effects or cancer worsening. They will be followed for up to 4 years.
