A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma.

NCT ID: NCT05228470

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-21
• Study Completion Date: 2025-09-11

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 bone that forces healthy blood cells to go out. Sometimes, multiple myeloma does not respond to current therapy or quickly progresses, and this is called refractory multiple myeloma.

Elranatamab is a study medicine that target multiple myeloma and activates the human body to fight against this disease. We are seeking Chinese participants to take part in this study. The study will be 2 parts, called part 1b and part 2. In part 1b, participants will receive Elranatamab at 2 steps priming and full dose as a sc (subcutaneous injection) therapy. We will monitor participants' safety and reactions to the study medicine. This will help us understand the dosage of Elranatamab to be used safely.

In part 2 of the study, participants will receive Elranatamab and their multiple myeloma growth will be monitored. This will help us understand if Elranatamab, when used alone, may be a therapy for refractory multiple myeloma. Participants in this part of the study are expected to take part for about 2 years.

Conditions

Elranatamab; Myeloma; Multiple Myeloma; Relapsed Multiple Myeloma; Refractory Multiple Myeloma; PF-06863135; BCMA; Bispecific; Bispecific Antibody; BCMA-CD3 Bispecific; MagnetisMM-8

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Elranatamab

BCMA-CD3 bispecific antibody

Group Type: EXPERIMENTAL

Elranatamab

Intervention Type: DRUG

BCMA-CD3 bispecific antibody

Interventions

Elranatamab

BCMA-CD3 bispecific antibody

Intervention Type: DRUG

Other Intervention Names

PF-06863135

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Shenzhen Second People's Hosptial

Shenzhen, Guangdong, China

Harbin First Hospital

Harbin, Heilongjiang, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jilin, China

Shandong Provincial Hospital

Jinan, Shandong, China

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Beijing Gaobo Boren Hospital

Beijing, , China

Peking University Third Hospital

Beijing, , China

Peking Union Medical College Hospital

Beijing, , China

Hematology Hospital, Chinese Academy of Medical Sciences

Tianjin, , China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C1071008

To obtain contact information for a study center near you, click here.

Other Identifiers

C1071008

Identifier Type: -

Identifier Source: org_study_id

NCT05228470

Identifier Type: REGISTRY

Identifier Source: secondary_id