A Study to Evaluate the Safety, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma

Launched by GENENTECH, INC. · Dec 2, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for people with relapsed or refractory multiple myeloma (a type of blood cancer that keeps coming back or doesn't respond to treatment). The study will test the safety and effectiveness of two drugs, XmAb24306 and cevostamab, given together. To be eligible for this trial, participants should be adults aged 65 and older who have already tried at least three different treatments for their cancer. These treatments must include specific types of medications: one that breaks down proteins (called a proteasome inhibitor), one that helps the immune system (known as an immunomodulatory drug), and one that targets a specific protein on cancer cells (an anti-CD38 monoclonal antibody).

Participants in this trial can expect to receive close monitoring and support throughout the study. They will need to agree to follow certain health guidelines and contraception requirements. It's important to note that individuals with certain health conditions or those who have recently undergone specific cancer treatments may not be eligible. This trial is currently recruiting participants who meet the criteria, and it aims to provide new insights into treating multiple myeloma effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• • Life expectancy of at least 12 weeks
• • Participants must have received a minimum of 3 prior lines of therapy, including at least one PI, one IMiD, and an anti-CD38 monoclonal antibody.
• • Documented evidence of progressive disease on or after the last prior therapy, or participants who were intolerant to the last prior therapy.
• • Measurable disease, as defined by the protocol
• • Participants agree to follow contraception or abstinence requirements as defined in the protocol
• Exclusion Criteria:
• • Any anti-cancer therapy within 3 weeks prior to initiation of study treatment with exception defined by the protocol
• • Participants with autologous stem cell transplantation (SCT) within 100 days prior to first dose of study treatment
• • Participants with prior allogeneic SCT or solid organ transplantation
• • Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
• • Active or history of autoimmune disease
• • Participants with current or history of Central Nervous System (CNS) disease, or current CNS involvement by Multiple Myeloma (MM)
• • Significant cardiovascular disease
• • Participants with known clinically significant liver disease
• • Symptomatic active pulmonary disease requiring supplemental oxygen
• • Known active infection requiring intravenous anti-microbial therapy within 14 days prior to first study drug administration
• • Any episode of active, symptomatic COVID-19 infection, or requiring treatment with IV antivirals for COVID-19 (not including COVID-19 primary prophylaxis) within 14 days, prior to first study treatment
• • Other protocol defined inclusion/exclusion criteria may apply

Trial Officials