A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma

Launched by TENEOONE INC. · Feb 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a new drug called ABBV-383 when given together with other treatments for adults with relapsed or refractory multiple myeloma, a type of blood cancer. The goal is to see how well this combination works and to monitor any side effects that participants might experience. Participants will receive ABBV-383 through an intravenous (IV) infusion along with one of the following treatments: pomalidomide-dexamethasone, lenalidomide-dexamethasone, daratumumab-dexamethasone, or nirogacestat, all in cycles lasting 28 days.

To participate, individuals must be adults with a confirmed diagnosis of relapsed or refractory multiple myeloma and have had measurable disease progression after their last treatment. They should also be in good overall health, not have received certain previous therapies, and meet other specific criteria. Throughout the study, participants will attend regular medical visits, where their health will be closely monitored through various assessments and tests. It's important to note that this trial may involve more frequent treatments and visits compared to standard care for multiple myeloma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
• • Must have confirmed diagnosis of Relapsed/Refractory (R/R) Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria.
• • Must have measurable disease as determined by central lab as outlined in the protocol.
• • Must be naïve to treatment with Etentamig.
• • Must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
• • Arms A, B and C: Participant has received at least 3 prior lines of MM treatment.
• • Arm E: Participant has received 1-3 prior lines of MM treatment.
• Exclusion Criteria:
• • Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study treatment.
• • Unresolved adverse event (AE)s \>= Grade 2 (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) from prior anticancer therapy.
• * Has any of the following conditions:
• • Nonsecretory Multiple Myeloma (MM).
• • Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or \> 2.0 × 10\^9L circulating plasma cells by standard differential.
• • Waldenstrom's macroglobulinemia.
• • Light chain amyloidosis.
• • Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
• • Major surgery within 4 weeks prior to first dose or planned study participation.
• • Acute infections within 14 days prior to first dose of study requiring therapy (antibiotic, antifungal or antiviral).
• • Uncontrolled diabetes or hypertension within 14 days prior to first dose.
• • Peripheral neuropathy \>= Grade 3 or \>= Grade 2 with pain within 2 weeks prior to first dose.