Elranatamab in R/R Multiple Myeloma

Inclusion Criteria:

• Participant has given voluntary signed written informed consent before performance ofany study related procedure that is not part of normal medical care, with theunderstanding that consent may be withdrawn by the participant at any time withoutprejudice to their future medical care.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
• Male or female participants age ≥ 18 years
• The effects of elranatamab on the developing human fetus are unknown. For this reasonand because anti-BCMA bispecific antibodies are known to be teratogenic, women ofchild-bearing potential and men must agree to use adequate contraception (hormonal orbarrier method of birth control; abstinence) prior to study entry and for the durationof study participation. Should a woman become pregnant or suspect she is pregnantwhile she or her partner is participating in this study, she should inform hertreating physician immediately. Men treated or enrolled on this protocol must alsoagree to use adequate contraception prior to the study, for the duration of studyparticipation, and 4 months after completion of elranatamab administration.
• Prior diagnosis of MM as defined according to IMWG criteria.
• Measurable disease of multiple myeloma as defined by at least one of the followingprior to idecabtagene vicleucel infusion:
• Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amountsof monoclonal protein may be permitted to enroll with PI approval
• ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
• Serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free kappa toserum free kappa light chain ratio (<0.26 or >1.65)
• Previously treated relapsed and refractory multiple myeloma following idecabtagenevicleucel as infusion as standard of care who have achieved at least a PR or betterper IMWG criteria. Patients will have received idecabtagene per label including afterat least 4 prior lines of therapy and relapsed after an immunomodulatory drug (IMiD),a proteasome inhibitor and an Anti-CD38 monoclonal antibody
• left ventricular ejection fraction (LVEF) ≥40% as determined by a multiple gatedacquisition scan (MUGA) scan or echocardiogram (ECHO).
• Participants must meet the following organ and marrow function as defined below:
• Absolute neutrophil count ≥1000/microlitre (mcL). Use of granulocyte-colonystimulating factors is permitted if completed at least 7 days prior to plannedstart of dosing.
• Platelet count ≥25,000/mcL. Platelet transfusion support is permitted ifcompleted at least 7 days prior to planned start of dosing.
• Hemoglobin ≥8 g/dL. Red blood cell transfusion support is permitted if completedat least 7 days prior to planned start of dosing.
• Calculated creatinine clearance ≥30 mL/min by Cockcroft-Gault equation.
• Patient has adequate hepatic function, as evidenced by each of the following:
• Serum total bilirubin <2 mg/dL; and
• Serum aspartate transaminase (ALT) and/or aspartate transaminase (AST)values < 2.5 × the upper limit of normal (ULN) of the institutionallaboratory reference range. Patients with elevated bilirubin due toGilbert's syndrome may be permitted with PI approval (e.g. total bilirubin <3 mg/dL and normal direct bilirubin).
• Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)

Exclusion Criteria:

• Patients with smoldering MM, plasma cell leukemia, POEMS syndrome, or amyloidosis areexcluded from this trial.
• Stem cell transplant within 12 weeks prior to enrollment or active graft-versus-hostdisease (GVHD).
• Active hepatitis B virus, hepatitis C virus, Severe acute respiratory syndromecoronavirus 2 (SARS-CoV2), HIV, or any active, uncontrolled bacterial, fungal, orviral infection. Active infections must be resolved at least 14 days prior toenrollment.
• Impaired cardiovascular function or clinically significant cardiovascular diseases,defined as any of the following within 6 months prior to enrollment:
• Acute myocardial infarction or acute coronary syndromes (eg, unstable angina,coronary artery bypass graft, coronary angioplasty or stenting, symptomaticpericardial effusion);
• Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillationor uncontrolled paroxysmal supraventricular tachycardia);
• Thromboembolic or cerebrovascular events (eg, transient ischemic attack,cerebrovascular accident, deep vein thrombosis [unless associated with a centralvenous access complication] or pulmonary embolism);
• Prolonged QT syndrome (or triplicate average QTcF >470 msec at screening).
• Any other active malignancy within 3 years prior to enrollment, except for adequatelytreated basal cell or squamous cell skin cancer, or carcinoma in situ.
• Ongoing Grade ≥2 peripheral sensory or motor neuropathy.
• History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3peripheral motor polyneuropathy.
• Previous treatment with an anti-BCMA (B-cell maturation antigen) bispecific antibody.
• Pregnant women are excluded from this study because elranatamab is an anti-BCMAbispecific antibody agent with the potential for teratogenic or abortifacient effects.Because there is an unknown but potential risk for adverse events in nursing infantssecondary to treatment of the mother with elranatamab, breastfeeding should bediscontinued if the mother is treated with elranatamab. Known or suspected hypersensitivity to the study intervention or any of its excipients. Participants who are receiving any other investigational agents for this condition (ifappropriate only). Live attenuated vaccine must not be administered within 4 weeks of the first dose of studyintervention. Toxicity from previous anticancer therapy must resolve to baseline levels or to grade ≤1,except for alopecia and peripheral neuropathy. Other surgical (including major surgery within 14 days prior to enrollment), medical orpsychiatric conditions including recent (within the past year) or active suicidalideation/behavior or laboratory abnormality that may increase the risk of studyparticipation or, in the investigator's judgment, make the participant inappropriate forthe study. Previous administration with an investigational drug within 30 days (or as determined bythe local requirement) or 5 half-lives preceding the first dose of study intervention usedin this study (whichever is longer).