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

NCT05228470 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: C1071008NCT05228470
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 15

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

Keywords

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Outcome Measures

Primary Outcomes (2)

• Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT)

  Grade(G)4 neutropenia \>5 day; febrile neutropenia (absolute neutrophil count \[ANC\] \<1000/millimeter cube (mm\^3) with single temperature \>38.3 degree Celsius (deg C) or sustained temp\>=38 deg C for \>1 hour(H); G\>=3 neutropenia with infection; G4 thrombocytopenia (unless baseline count \>=25,000/mm\^3 and \<50,000/mm\^3, in which case G4 thrombocytopenia to be accompanied by \>=G2 bleeding); Platelet count \<10,000/mm\^3; G3 thrombocytopenia with \>=G2 bleeding; G\>=4 AE; G3 cytokine release syndrome(CRS) except CRS not maximally treated/improved to \<=G1 within 48H; G3 AE except AE attributed to CRS, G3 nausea,vomiting,diarrhea improved to G\<=2 within 72H after medical management, G3 fatigue \<1 week, G3 AE recovered to baseline/G1 within 5 day; confirmed drug-induced liver injury; G3-4 laboratory (lab) abnormality except G3-4 lab abnormality improved to G\<=2 within 72H after medical management \& without sequelae;G3 injection site reaction; G2/other clinically important AE may be considered DLT.

  Cycle 1 (28 days)

• Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria

  ORR: Percentage of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum M-protein \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. If serum \& urine M-protein were unmeasurable, VGPR \& PR: \>=90% \& \>=50% decrease in difference respectively between involved \& uninvolved sFLC levels \& if present at baseline, \>=90% \& \>=50% reduction in soft tissue plasmacytomas' size.

  From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (approximately up to 16 months)

Secondary Outcomes (25)

• Duration of Response (DOR) as Per IMWG Criteria by BICR

  From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 37 months)

• Duration of Response (DOR) as Per IMWG Criteria by Investigator Assessment

  From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 37 months)

• Complete Response Rate (CRR) as Per IMWG Criteria by BICR

  From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 37 months)

• Complete Response Rate (CRR) as Per IMWG Criteria by Investigator Assessment

  From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 37 months)

• Objective Response Rate (ORR) as Per IMWG Criteria by Investigator Assessment

  From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 37 months)

Study Arms (1)

Elranatamab

EXPERIMENTAL

BCMA-CD3 bispecific antibody

Drug: Elranatamab

Interventions

Elranatamab DRUG

BCMA-CD3 bispecific antibody

Also known as: PF-06863135

Elranatamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (15)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510555, China

Location

Shenzhen Second People's Hosptial

Shenzhen, Guangdong, 518035, China

Location

Harbin First Hospital

Harbin, Heilongjiang, 150010, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

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

Nanjing, Jiangsu, 210008, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Beijing Gaobo Boren Hospital

Beijing, 100070, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Hematology Hospital, Chinese Academy of Medical Sciences

Tianjin, 300020, China

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Multiple Myeloma; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Lymphatic Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 8, 2022
• Study Start: December 21, 2021
• Primary Completion: August 6, 2023
• Study Completion: September 11, 2025
• Last Updated: January 6, 2026
• Results First Posted: September 19, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (15)