CLINICAL TRIAL FACT SHEET
ClinicalTrials.gov ID: NCT06158841
Assessment of activity of intravenous infusion of Etentamig (ABBV-383) monotherapy vs. standard available therapies in adult patients with relapsed or refractory multiple myeloma (RRMM)
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Clinical trial NCT06158841 is a phase III, multicenter, randomized, open label study. Approximately 380 adult patients with relapsed or refractory multiple myeloma (RRMM) will be enrolled at approximately 140 sites across the world.
Description
A clinical trial is a medical research study with people who volunteer to test scientific approaches to a new treatment or a new combination therapy. Each clinical trial is designed to find better ways to prevent, detect, diagnose, or treat cancer and to answer scientific questions.
Etentamig (ABBV-383) is an investigational drug being developed for the treatment of RRMM. This study will compare outcomes in adult patients with RRMM who receive Etentamig (ABBV-383) to those who receive standard available therapies (SAT).
Primary outcome measure
Progression-Free Survival (PFS), defined as the duration of time from the date of randomization to the date of confirmed disease progression (PD) determined by independent review committee (IRC) per 2016 response criteria by the International Myeloma Working Group (IMWG), or death, whichever occurs first. Up to approximately 5 years.
Objective Response Rate (ORR), defined as the percentage of participants who achieve confirmed partial response (PR), very good partial response (VGPR), complete response (CR), and stringent complete response (sCR), or per IRC assessment. Up to approximately 5 years.
Clinical trial design
The Etentamig (ABBV-383) study has two arms, with participants enrolled into one of the arms. Efficacy of treatment as well as the possible effects of adverse events will be checked by medical assessments, blood tests, and questionnaires. Study duration is expected to last approximately 3.5 years.
Arm A: Participants will receive Etentamig (ABBV-383) as a monotherapy, a single drug used alone to treat myeloma. Participants will receive an intravenous (IV) infusion of Etentamig (ABBV-383) in Cycles of 28 days each. Arm A participants will attend regular visits at a hospital or clinic and may have a higher treatment burden compared to patients who receive standard available therapy (SAT).
Arm B: Participants will receive standard available therapy (SAT) as identified by the study investigator during the patient screening process, in accordance with applicable approved label, package insert, summary of product characteristics, and/or institutional guidelines. SAT choices are the following:
• Kyprolis® (carfilzomib) + dexamethasone
• Empliciti® (elotuzumab) + Pomalyst® (pomalidomide) + dexamethasone
• Xpovio® (selinexor) + Velcade® (bortezomib) + dexamethasone
(continues on reverse side)