Multiple Myeloma Clinical Trial
Official title:
A Prospective, Multicenter, Non-comparative, Open-label, Phase II Study to Evaluate the Effects of Daratumumab Monotherapy on Bone Parameters in Patients With Relapsed and /or Refractory Multiple Myeloma Who Have Received at Least 2 Prior Lines of Therapy, Including Lenalidomide and a Proteasome Inhibitor
The purpose of this study is to evaluate the effects of daratumumab monotherapy on bone disease in patients with relapsed/refractory MM who have received at least 2 prior lines of therapy, including lenalidomide and a PI.
This is a prospective, multicenter, non-comparative, open-label Phase II study. Daratumumab
will be administered according to approved label. Approximately 57 subjects located in Greece
will be enrolled in the study.
Patients shall receive treatment until disease progression, physician decision, unacceptable
toxicity, withdrawal of consent, or death (whichever occurs first). Survival status and data
of subsequent anti-myeloma treatment will be collected post-treatment.
Primary and secondary variables related to bone disease markers will be evaluated every other
cycle of therapy. Disease evaluations will occur monthly and consist mainly of measurements
of myeloma proteins. Other parameters may include bone marrow examinations, skeletal surveys,
assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for
albumin, and β2- microglobulin and albumin. Assessment of myeloma response and disease
progression will be conducted in accordance with the modified IMWG response criteria
;
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