Elranatamab Expanded Access Protocol in Adults With Relapsed/Refractory Multiple Myeloma (MAGNETISMM17)

This is an expanded access trial for Multiple Myeloma focused on measuring Multiple Myeloma, Erlanatamab, Expanded Access, MM17, MagnetisMM-17, BCMA, BCMA antibody, Advanced multiple myeloma, Relapse/Refractory, RRMM, MagnetisMM, MagnetisMM US, Bispecific Antibody Read More

Inclusion Criteria:

• Prior diagnosis of MM as defined according to IMWG criteria .
• Patients who are ineligible for participation in any ongoing clinical trial of elranatamab, including lack of access due to geographical limitations, and who have exhausted all other treatment options.
• Measurable disease based on IMWG criteria as defined by at least 1 of the following:
• Serum M-protein ≥0.5 g/dL (≥5 g/L)
• Urinary M-protein excretion ≥200 mg/24 hours
• Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
• Refractory to at least one IMiD, one PI, and one anti-CD38 antibody.
• Relapsed/refractory to last anti-MM regimen.
• ECOG performance status 0-1.
• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
• Not pregnant, willing to use contraception

Exclusion Criteria:

• Smoldering MM; plasma cell leukemia; POEMS syndrome; Waldenström's macroglobulinemia; amyloidosis; stem cell transplant within 12 weeks prior to enrollment or active GVHD
• Previous treatment with BCMA directed therapy;
• SARS-CoV2, HIV, HBV, HCV or any active, uncontrolled bacterial, fungal, or viral infection.

Active infections must be resolved at least 14 days prior to enrollment.

• Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ or Stage 0/1 with minimal risk of recurrence per treating physician.
• Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)