Multiple Myeloma Drug Treatment Study
This study is for patients with newly diagnosed multiple myeloma who are not candidates for autologous stem cell transplant due to their age or health. The study compares Lenalidomide/dexamethasone, which is a standard of care treatment, versus the same regimen given in combination with novel monoclonal antibody Daratumumab.
In order to participate you must meet the following criteria:
Must be newly diagnosed with MM and not considered a candidate for high-dose chemotherapy with stem cell transplantation due to the following:
- Are ≥65 years of age.
- Are <65 years and have other significant health condition(s) that would affect ability to tolerate high-dose chemotherapy.
- Must have adequate performance status, able to care for yourself and complete activities of daily living with limited restrictions.
- Must meet pretreatment laboratory value criteria.
You will be excluded from the study if any of the following criteria apply to you:
- Have a diagnosis of primary amyloidosis, smoldering myeloma, MGUS, or Waldenstrom’s disease.
- Have received any prior or current therapy or ASCT for MM. (Exception of emergency use of a short course of corticosteroids.)
- Have had radiation (<14 days), major surgery (<14 days), plasmapheresis (<28 days).
- Have a known history of obstructive airway disease (COPD), persistent asthma, or a history of asthma within the last 2 years (intermittent asthma is allowed), human immunodeficiency virus (HIV) or active hepatitis B or hepatitis C, clinically significant cardiac disease (myocardial infarction within one year; unstable chest pain; congestive heart failure; uncontrolled irregular heart rate; clinically significant electrocardiogram abnormalities or QTcF >470 msec).
This is a partial list of inclusion and exclusion criteria.