MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb

• Status: Recruiting
• Trial end date: 2024-01-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)

• Measurable disease, as defined by at least 1 of the following:

1. Serum M-protein >0.5 g/dL by SPEP

2. Urinary M-protein excretion >200 mg/24 hours by UPEP

3. Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio

• Refractory to at least one IMiD

• Refractory to at least one PI

• Refractory to at least one anti-CD38 antibody

• Relapsed/refractory to last anti-myeloma regimen

• Cohort A: has not received prior BCMA-directed therapy

• Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells)

• ECOG performance status ≤2

• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1

• Not pregnant and willing to use contraception

Exclusion Criteria:

• Smoldering multiple myeloma

• Active Plasma cell leukemia

• Amyloidosis

• POEMS syndrome

• Stem cell transplant within 12 weeks prior to enrollment

• Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection

• Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.

• Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)