Status:
COMPLETED
A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma.
Lead Sponsor:
Pfizer
Conditions:
Elranatamab
Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to understand the study medicine (called Elranatamab, or PF-06863135) as potential treatment for refractory multiple myeloma. Multiple myeloma is a form of cancer in the b...
Eligibility Criteria
Inclusion
- 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:
- Absolute neutrophil count ≥1.0 × 10\^9/L
- Platelets ≥ 25 × 10\^9/L
- 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
- 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)
Key Trial Info
Start Date :
December 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2025
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT05228470
Start Date
December 21 2021
End Date
September 11 2025
Last Update
January 6 2026
Active Locations (15)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
2
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
3
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
4
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510555