A Study to Evaluate the Safety, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma
Cevostamab: Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
XmAb24306: XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
Tocilizumab: Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
Study summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with cevostamab in participants with relapsed/refractory multiple myeloma (R/R MM) who have received a minimum of three prior treatments, including at least one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one anti-CD38 monoclonal antibody.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Percentage of Participants with Adverse Events (AEs) — Up to approximately 3 years Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and Cytokine Release Syndrome (CRS), will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Trial sites (13)
Facility
City
Region
Status
Royal Adelaide Hospital
Adelaide
South Australia
Peter Maccallum Cancer Centre
Melbourne
Victoria
Alfred Hospital
Melbourne
Victoria
Sygehus Lillebaelt - Vejle Sygehus
Vejle
Denmark
Evangelismos General Hospital of Athens
Athens
Greece
University of Athens, Hematological Clinic,
Athens
Greece
Rabin Medical Center-Beilinson Campus
Petah Tikva
Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv
Israel
Oslo University Hospital Rikshospitalet
Oslo
Norway
Severance Hospital, Yonsei University
Seoul
South Korea
Asan Medical Center - PPDS
Seoul
South Korea
Clinica Universidad de Navarra
Pamplona
Navarre
Hospital Universitari i Politecnic La Fe de Valencia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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