About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.
Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.
Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
Have clinical laboratory values within the specified range.
Disqualifiers
Smoldering multiple myeloma.
Plasma cell leukemia.
Amyloidosis.
Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.
Trial design
Parallel
Treatments tested in this trial
Elranatamab
DrugElranatamab will be administered subcutaneously
Elotuzumab
DrugElotuzumab will be administered intravenously
Pomalidomide
DrugPomalidomide will be administered orally
Dexamethasone
DrugDexamethasone will be administered orally
Bortezomib
DrugBortezomib will be administered subcutaneously or intravenously
Carfilzomib
DrugCarfilzomib will be administered intravenously
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Overall survival
From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first
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
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
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