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

About

Brief Summary

Elranatamab is a bispecific antibody: binding of elranatamab to CD3- expressing T-cell and BCMA- expressing multiple myeloma cells causes targeted T-cell mediated cytotoxicity.

This expanded access protocol will provide access to elranatamab until it becomes commercially available to patients who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody and have no access to other comparable/alternative therapy and for whom elranatamab could be a possible treatment option.

Study Type

Expanded Access

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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 or experience lack of access to commercially available therapies due to geographical, financial or socioeconomic limitations.
Measurable disease at screening 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;
Active HBV, HCV, SARS- CoV-2, HIV 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)

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