The main purpose of the study is to evaluate the efficacy (transfusion independence [TI])
of talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent participants with
low or intermediate-1 risk Myelodysplastic Syndrome (MDS) whose disease has relapsed
during treatment with or is refractory to Erythropoiesis-Stimulating Agent (ESAs).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03011034.
This is a multicenter, randomized (study drug assigned by chance), open-label
(participants and researchers are aware of the treatment participants are receiving)
study to evaluate the safety and efficacy of talacotuzumab or daratumumab. Approximately
60 participants (30 to receive talacotuzumab and 30 to receive daratumumab) will be
enrolled and then assigned randomly on a 1:1 basis to receive either talacotuzumab or
daratumumab. The study consists of: a Screening Phase of up to 28 days during which
participant eligibility will be reviewed and approved by the sponsor prior to
randomization, a Treatment Phase that will extend from the first dose on Cycle 1 Day 1
until study drug discontinuation, and a Post-treatment Follow up Phase beginning once the
participant discontinues talacotuzumab or daratumumab. Study drugs will continue to be
administered until disease progression, lack of response, unacceptable toxicity,
withdrawal of consent, or study end. Safety will be monitored throughout the study. The
talacotuzumab arm of the study is closed for enrollment.
Lead OrganizationJanssen Pharmaceuticals
