AU Study Recruitment

Eligibility Criteria

• Age 1. At the time of informed consent, be ?18 years of age or at least the legal age of majority in the jurisdiction in which the study is taking place. Type of Participant and Disease Characteristics 2. Documented diagnosis of MM as defined by the criteria below: a. MM diagnosis according to the IMWG diagnostic criteria (Rajkumar 2014) b. Measurable disease at screening as assessed by central laboratory, defined by any of the following: i. Serum M-protein level ?0.5 g/dL; or ii. Serum Ig FLC ?10 mg/dL and abnormal serum Ig kappa lambda FLC ratio; or iii. Urine M-protein level ?200 mg/24 hours NOTE: In exceptional circumstances and after discussion with, and written approval by, the sponsor, local laboratory results may be used to determine initial eligibility, but only if the local results are clearly (?25%) above the thresholds for measurability. In such cases, central laboratory results should still be obtained from samples collected prior to the start of study treatment to establish baseline values and confirm the results from the local laboratory. 3. Received 1 to 3 prior lines of antimyeloma therapy, including an anti-CD38 antibody and lenalidomide. The participant must have undergone at least 2 consecutive cycles of an anti-CD38 antibody at the approved dosing schedule (or a minimum of 6 doses if the anti-CD38 antibody was only part of a maintenance regimen) in any prior line and 2 consecutive cycles of lenalidomide in any prior line, unless PD was the best response to the line of therapy

Contact Information

    Rebecca Becky Paynter, RN

    (706) 446-5177

   rpaynter@augusta.edu