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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Percentage of Participants with Adverse Events (AEs)
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.
Time frame: Up to approximately 3 years
Serum Concentration of XmAb24306
Time frame: Up to approximately 3 years
Serum Concentration of Cevostamab
Time frame: Up to approximately 3 years
Objective Response Rate (ORR)
ORR will be determined by the investigator according to International Myeloma Working Group (IMWG) criteria.
Time frame: Up to approximately 3 years
Rate of Complete Response (CR)/ Stringent Complete Response (sCR)
Rate of CR/sCR will be determined by the investigator.
Time frame: Up to approximately 3 years
Rate of Very Good Partial Response (VGPR)
Rate of VGPR will be determined by the investigator.
Time frame: Up to approximately 3 years
Percentage of Participants With Anti-Drug Antibodies (ADA) to XmAb24306 and Cevostamab
Time frame: Up to approximately 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 3 more locations