A Phase II Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma

1. History of antitumor therapy as follows, before the first dose of study drug
   1. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is shorter.
   2. Monoclonal antibody treatment for MM within 21 days.
   3. Cytotoxic therapy within 21 days.
   4. PI therapy within 14 days.
   5. Immunomodulatory agent therapy within 7 days.
   6. Radiotherapy within 14 days or focal radiation within 7 days.
   7. Prior gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified [CAR]-T cells) ≤12 weeks before the first dose of study drug
2. Has received any of the following:
   1. Packed red blood cells within the last 7 days prior to dosing
   2. Platelet transfusions within the last 7 days prior to dosing
   3. Live vaccine within 1 month prior to screening or plans to receive a live vaccine during the study
3. History of Grade ≥3 CRS or ICANS with prior therapies.
4. Current treatment with strong or moderate inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) that cannot be discontinued at least 7 days prior to the start of elranatamab treatment and during the study.
5. Has myelodysplastic syndrome or active malignancies (i.e., progressing or requiring treatment change in the last 12 months) other than RRMM. The only allowed exceptions are:

a. Malignancies treated within the last 12 months and considered at very low risk for recurrence: i. Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, <3 cm, no CIS).

ii. Skin cancer (non-melanoma or melanoma). iii. Noninvasive cervical cancer. iv. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, localized breast cancer and receiving antihormonal agents.

v. Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP/RT/focal treatment).

b. Other malignancy that is considered at minimal risk of recurrence. In the event of any questions, consult with the Medical Monitor prior to enrolling a participant.

6. Has active autoimmune disease or documented history autoimmune disease with exception of vitiligo, type I diabetes mellitus, or prior autoimmune thyroiditis currently euthyroid based on symptoms and labs.
7. Has active plasma cell leukemia (≥20% peripheral blood plasma cells and ≥2.0×109/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
8. Any of the following cardiac criteria currently or within the last 6 months:
   1. Have documented major electrocardiogram (ECG) abnormalities which are clinically significant at the Investigator's discretion (for example, symptomatic or sustained atrial or ventricular arrhythmias, second- or third-degree atrioventricular block, bundle-branch blocks, ventricular hypertrophy, or recent myocardial infarction or a mean QTc of >470 ms [calculated using Fridericia's Correction, confirmed by triplicate ECG])
   2. Cardiac function: left ventricular ejection fraction (LVEF) assessed by ECHO or MUGA <45% (evaluation based on institutional lower limit of normal) and the patient has a significant cardiac history, or the investigator suspects ongoing cardiac pathology
   3. Have the presence of cardiac disease, including a myocardial infarction or any other arterial thrombotic event including cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment, unstable angina pectoris, New York Heart Association (NYHA) Class III-IV congestive heart failure, aneurysm of major vessels or heart, uncontrolled hypertension.
   4. Overall cardiac ineligibility determined by the Investigator based on medical history and clinically indicated evaluations
9. Any significant neurologic or psychiatric conditions diagnosed and/or ongoing in the last 6 months prior to anticipated treatment start date including but not limited to severe brain injury, stroke, intracranial hemorrhage, seizure, dementia, or Parkinson's disease. Participants with a history of uncontrolled epilepsy requiring anticonvulsants are excluded if therapy not stable within 6 months prior to enrollment.
10. Active central nervous system (CNS) multiple myeloma involvement.
11. Has fever or active infection (bacterial, viral, or uncontrolled systemic fungal) at time of study enrollment.
12. Has hepatitis B infection (i.e., HBsAg or HBV-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status. See Section 7.4.7 for further required assessments.
13. Has active hepatitis C infection as measured by positive HCV-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study.
14. Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 4 months after the last administration of study treatment.
15. Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment.
16. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection, including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.
17. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.