The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.
Elranatamab solution for injection will be administered SC as specified in each treatment arm.
Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
RECRUITINGCalvary Mater Newcastle
Waratah, New South Wales, Australia
RECRUITINGNumber 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). The severity of CRS, immune effector cell-associated neurotoxicity syndrome (ICANS) and hemophagocytic lymphohistiocytosis (HLH) will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) Grading Scales.
Time frame: From signing of informed consent up to end of study (EOS) (approximately 36 months)
Recommended Phase II Regimen (RP2R)
Time frame: Up to approximately 36 months
Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria
Time frame: Up to approximately 36 months
Complete Response (CR)/ Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria
Time frame: Up to approximately 36 months
Rate of Very Good Partial Response (VGPR) or Better, as Determined by the Investigator per IMWG Criteria
Time frame: Up to approximately 36 months
Progression-Free Survival as Determined by the Investigator per IMWG Criteria
Time frame: Up to approximately 36 months
Duration of Response (DOR) as Determined by the Investigator (for Participants who Achieve a Response of Partial Response (PR) or Better)
Time frame: Up to approximately 36 months
Time to First Response (for Participants who Achieve a Response of PR or Better)
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Royal Adelaide Hospital;Haematology Clinical Trials Unit
Adelaide, South Australia, Australia
RECRUITINGThe Alfred Hospital
Prahan, Victoria, Australia
RECRUITINGRambam Health Care Campus
Haifa, Israel
RECRUITINGHadassah University Hospital - Ein Kerem
Jerusalem, Israel
RECRUITINGSheba Medical Center - PPDS
Ramat Gan, Israel
RECRUITINGTel Aviv Sourasky Medical Center PPDS
Tel Aviv, Israel
RECRUITINGThe Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
Seocho, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITING...and 1 more locations
Time frame: Up to approximately 36 months
Time to Best Response (for Participants who Achieve a Response of PR or Better)
Time frame: Up to approximately 36 months
Overall Survival (OS)
Time frame: Up to approximately 36 months
Serum Concentration of Cevostamab at Specified Timepoints
Time frame: Up to approximately 36 months
Serum Concentration of Elranatamab at Specified Timepoints
Time frame: Up to approximately 36 months
Number of Participants with Anti-Drug Antibody (ADA) Against Cevostamab
Time frame: Up to approximately 36 months
Number of Participants with ADA Against Elranatamab
Time frame: Up to approximately 36 months