Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis

Exclusion Criteria

• •Prior BCMA-targeting bispecific antibodies or BCMA-targeting CAR-T therapy.
• •Participants refractory to belantamab mafodotin OR participants that have received belantamab as the immediate past line of therapy.
• •Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
• •Participants who are receiving any other investigational agents for this condition.
• •Participants with Stage IIIB Amyloidosis as defined by the 2004 Mayo Clinic Criteria (see above).
• •History of allergic reactions to elranatamab.
• •Participants with an active malignancy (including lymphoma) with the following exceptions: adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancer; adequately treated stage I cancer from which the patient is currently in remission and has been for over 2 years; low-risk prostate cancer with a Gleason score \< 7 and prostate specific antigen \< 10ng/mL; other localized, indolent and/or low risk cancer may be permitted
• •Women who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or 4 months following discontinuation of elranatamab, whichever is longer. Pregnant women are excluded from this study because elranatamab is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with elranatamab, breastfeeding should be discontinued if the mother is treated with elranatamab.
• •Have any other medical, social or psychological factors that could affect the participant's safety or ability to consent personally or comply with study procedures.
• •Participants meeting criteria for active MM based on presence of CRAB criteria (a ratio of involved versus uninvolved FLC over 100 is allowed in the absence of CRAB criteria).
• •Participants with active clinically significant autoimmune diseases.
• •Participants seropositive for the human immunodeficiency virus (HIV).
• •Severe, uncontrolled orthostatic hypotension resulting in syncopal/pre-syncopal events despite optimized medical management (e.g., midodrine, pyridostigmine) and in the absence of volume depletion.
• •Plan for autologous stem cell transplant during the first 6 months of protocol therapy.
• •History of acute coronary syndrome or uncontrolled ventricular arrhythmias within 3 months prior to screening.
• •Evidence of LV systolic dysfunction as defined by LVEF is \< 30% by echocardiogram at Screening per site cardiology interpretation.
• •Presence of severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area \< 1.0 cm2) or severe congenital heart disease.
• •Have history of sustained ventricular tachycardia or aborted ventricular fibrillation or a history of atrioventricular nodal or sinoatrial nodal dysfunction if a permanent pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) is not placed.
• •QT corrected by Fridericia (QTcF) is \> 550 msec on Screening ECG unless they have a PPM/ICD implanted.
• •Screening EKG showing acute myocardial ischemia or active conduction system abnormalities with the exception of any of the following: First degree atrioventricular block; Second degree atrioventricular block Type 1 (Mobitz Type 1/Wenckebach type); Right or left bundle branch block (e.g., Left Bundle Branch Block, Right Bundle Branch Block, Left Anterior Fascicular Block, or Left Posterior Fascicular Block); Atrial fibrillation with a controlled ventricular rate; Bifascicular block assessed as benign by the Investigator
• •Major surgery that required general anesthesia within 4 weeks of randomization or is planning major surgery during the study.
• •NYHA class IV symptoms or participants with acute decompensation of congestive heart failure.