MagnetisMM-8: Study Of Elranatamab (PF-06863135) Monotherapy in Chinese Participants With Refractory Multiple Myeloma

• Status: Recruiting
• Trial end date: 2025-01-29
• Target enrollment: 0
• Participant gender: All

Summary

Study C1071008 includes 2 parts. The objective of Phase 1b part is to establish the safety profile in order to confirm the monotherapy RP2D in Chinese participants. The Phase 2 part is a single stage design to evaluate the efficacy and safety in Chinese participants. 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:

• Serum M-protein >0.5 g/dL

• Urinary M-protein excretion >200 mg/24 hours

• 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

• ECOG performance status ≤2

• Adequate BM function characterized by the following:

1. Absolute neutrophil count ≥1.0 × 10^9/L

2. Platelets ≥ 25 × 10^9/L

3. Hemoglobin ≥8 g/dL

• 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 or active GVHD within 12 weeks prior to enrollment.

• Previous treatment with an anti-BCMA directed therapy

• Impaired cardiovascular function or clinically significant cardiovascular diseases

• Ongoing Grade ≥2 peripheral sensory or motor neuropathy. History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.

• 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)