Elranatamab in Relapsed/Refractory Multiple Myeloma

Inclusion Criteria

• •1. Provision of signed and dated informed consent form
• •2. Stated willingness to comply with all study procedures and availability for the duration of the study
• •3. Prior diagnosis of relapsed/refractory MM and have received 1 to 3 prior lines of therapy as defined by the IMWG criteria (Rajkumar et al., 2014) including anti-CD38 monoclonal antibody, proteosome inhibitor (PI), and immunomodulatory drug (IMiD), and BCMA-directed chimeric antigen receptor T-cell (CAR T-cell) therapy
• •1. Refractory is defined as having disease progression while on therapy or within 60 days of last dose in any line, regardless of response.
• •2. If participant has not received BCMA-directed CAR T-cell therapy, must be ineligible for CAR T-cell therapy or deferred such treatment by participant
• •4. Aged greater or equal to 18 years
• •5. Measurable disease as defined by any of the following:
• •1. Serum M-protein level ≥ 0.5 g/dL by serum protein electrophoresis (SPEP), or
• •2. Urine M-protein ≥ 200mg/24 hours by urine protein electrophoresis (UPEP), or
• •3. Involved serum free light chain ≥ 10 mg/dL (≥100mg/L) AND an abnormal serum free light chain ratio in patients without measurable disease in the serum or urine
• •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• •7. Adequate hematological function defined as
• •1. Absolute neutrophil count (ANC) ≥1,000/mm3 (G-CSF not permitted for at least 1 week prior to the first dose of elranatamab)
• •2. Hemoglobin ≥8.0 g/dL (transfusion support is permitted if completed at least 1 week prior to planned start of dosing)
• •3. Platelet count ≥75,000/mm3 or ≥50,000/mm3 if \>50% involvement with plasma cells in the screening bone marrow (transfusion support is permitted if completed at least 1 week prior to planned start of dosing)
• •8. Adequate renal function with estimated creatinine clearance (CrCl) ≥30 mL/min as calculated using Cockcroft-Gault equation.
• •9. Adequate liver function defined as
• •1. Aspartate and alanine aminotransferase (AST and ALT) ≤2.5 x upper limit of normal (ULN); ≤5.0 x ULN if there is liver involvement by the tumor.
• •2. Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN in case of bone metastasis).
• •3. Total bilirubin ≤2.0 mg/dL, except in patients with Gilbert Syndrome who must have a total bilirubin less than 3.0 mg/dL.
• •10. Able to receive outpatient treatment of elranatamab by meeting the following criteria:
• •1. Lives within 30minutes from the site of medication administration
• •2. Reliable caregiver present, who is able to watch participant continuously for at least until 48 hours after administration of first full treatment dose
• •3. No history of grade 3-4 CRS or grade 3-4 ICANS from other immune effector cell or bispecific antibody therapies
• •11. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
• •12. Serum pregnancy test (for females of childbearing potential) negative at screening.
• •a. Female patients of non-childbearing potential must meet at least 1 of the following criteria: i. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.
• •ii. Have undergone a documented hysterectomy and/or bilateral oophorectomy. iii. Have medically confirmed ovarian failure. b. All other female patients (including female patients with tubal ligations) are considered to be of childbearing potential.
• •13. Agreement to adhere to Lifestyle Considerations (see section 5.3 and Appendix 2) throughout study duration