- Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease). Note: All above evaluations, for which there are measurable results at screening, will be repeated as indicated in the visit schedule and the schedule of assessments, with the exception of bone marrow plasmacytosis. Bone marrow plasmacytosis will be repeated for disease/response assessment according to the visit schedule and the schedule of assessments if it is the only measurable result at screening. If both serum and urine M-proteins are present, both must be followed in order to evaluate response.