The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who: * Are 18 years of age or older and have MM. * Have received treatments before for MM. * Have MM that has returned or not responded to their most recent treatment. Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as: * a shot under the skin at the study clinic * through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects. Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits). The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
492
Elranatamab will be administered subcutaneously
Elotuzumab will be administered intravenously
Pomalidomide will be administered orally
Dexamethasone will be administered orally
Bortezomib will be administered subcutaneously or intravenously
Carfilzomib will be administered intravenously
Infirmary Cancer Care
Mobile, Alabama, United States
RECRUITINGWestern Regional Medical Center, Inc. dba. City of Hope Phoenix
Goodyear, Arizona, United States
RECRUITINGBeverly Hills Cancer Center
Beverly Hills, California, United States
RECRUITINGCommunity Cancer Institute
Clovis, California, United States
Progression free survival per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
Time frame: Up to approximately 5 years
Overall survival
From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first
Time frame: Up to approximately 5 years
Progression free survival on next-line treatment per International Myeloma Working Group criteria
From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first
Time frame: Up to approximately 5 years
Objective response rate per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy
Time frame: Up to approximately 5 years
Duration of response per International Myeloma Working Group criteria
From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
Time frame: Up to approximately 5 years
Very good partial response or better response rate per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
Time frame: Up to approximately 5 years
Complete response rate per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
Time frame: Up to approximately 5 years
Duration of complete response per International Myeloma Working Group criteria
From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
Time frame: Up to approximately 5 years
Time to response per International Myeloma Working Group criteria
From date of randomization to date of confirmed objective response
Time frame: Up to approximately 5 years
Minimal residual disease negativity rate per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
Time frame: Up to approximately 5 years
Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
Time frame: Up to approximately 5 years
Duration of minimal residual disease negativity rate per International Myeloma Working Group criteria
From date of minimal residual disease negativity to date of relapse, death, or censoring, whichever occurs first
Time frame: Up to approximately 5 years
Frequency of treatment-emergent adverse events
Time frame: From date of first dose of study intervention up to 90 days after last study intervention administration
Frequency of abnormal laboratory results
Time frame: From date of first dose of study intervention up to 90 days after last study intervention administration
Free elranatamab serum trough concentration [Ctrough]
Time frame: From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab
Elranatamab immunogenicity by anti-drug antibodies against elranatamab
Time frame: From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
Change from baseline scores
Time frame: From date of informed consent up to approximately 35 days after last administration of study intervention
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20
Change from baseline scores
Time frame: From date of informed consent up to approximately 35 days after last administration of study intervention
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Clinical Research Advisors (Encino Satellite Location)
Encino, California, United States
RECRUITINGHoag Health Center Irvine
Irvine, California, United States
RECRUITINGHoag Hospital Irvine
Irvine, California, United States
RECRUITINGClinical Research Advisors (Korea Town Satellite Location)
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