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

Primary Purpose

Elranatamab, Myeloma, Multiple Myeloma

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Elranatamab
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elranatamab focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Fujian Medical University Union Hospital
  • Guangdong Provincial People's Hospital
  • Nanfang Hospital of Southern Medical University
  • Sun Yat-sen University Cancer Center
  • Shenzhen Second People's Hosptial
  • Harbin First Hospital
  • Harbin Medical University Cancer Hospital
  • Henan Cancer Hospital
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School
  • The first hospital of Jilin University
  • Shandong Provincial Hospital
  • The Affiliated Hospital of Qingdao University
  • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • Beijing Boren Hospital
  • Peking University Third Hospital
  • Peking Union Medical College Hospital
  • Hematology Hospital, Chinese Academy of Medical Sciences
  • Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elranatamab

Arm Description

BCMA-CD3 bispecific antibody

Outcomes

Primary Outcome Measures

Phase 1b: Number of participants with dose-limiting toxicities (DLT)
Number of participants with DLTs
Phase 2: Objective response rate
Objective response rate (IMWG response criteria)

Secondary Outcome Measures

Duration of response
Duration of response (IMWG response criteria)
Cumulative complete response rate
Cumulative complete response rate (IMWG response criteria)
Duration of cumulative complete response
Duration of cumulative complete response (IMWG response criteria)
Progression free survival
Progression free survival (IMWG response criteria)
Overall survival (OS)
Time to response (TTR)
Time to response (IMWG response criteria)
Minimal residual disease negativity rate
Minimal residual disease negativity rate (IMWG response criteria)
Frequency of treatment-emergent adverse events
Type and severity (including severity per NCI CTCAE v5)
Frequency of laboratory abnormalities
Complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)
Serum Concentration of Elranatamab (PF-06863135)
Serum concentrations of Elranatamab (PF-06863135) will be reported.
Immunogenicity of elranatamab (PF-06863135)
Immunogenicity of elranatamab (anti-drug antibodies against elranatamab)
Change from Baseline in Patient-Reported Outcomes as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)
The QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale.
Change from Baseline in Patient-Reported Outcomes as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire myeloma-specific module (EORTC QLQ-MY20)
The EORTC MY20 is a myeloma-specific module to assess quality of life in patients with multiple myeloma. It contains 20 items which can be grouped into a disease symptom subscale (6 items), side effects of treatment subscale (10 items), body image (1 item) and future perspective subscale (3 items)
Change from Baseline in Patient-Reported Outcomes as Assessed by EuroQol Five Dimension Questionnaire (EQ-5D)
The EQ-5D is a 6-item patient-completed questionnaire designed to assess health status in terms of a single index value or utility score. There are 2 components, a Health State Profile which has individuals rate their level of problems in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a VAS in which patients rate their overall health status from 0 (worst imaginable) to 100 (best imaginable).
Change from Baseline in Patient-Reported Outcomes as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ CIPN20)
The EORTC QLQ CIPN20 is a module developed to assess chemotherapy-induced peripheral neuropathy. It contains 20 items which can be grouped into a sensory subscale (9 items), motor subscale (8 items) and autonomic subscale (3 items).

Full Information

First Posted
January 5, 2022
Last Updated
August 29, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05228470
Brief Title
A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma.
Official Title
A PHASE 1B/2, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF ELRANATAMAB (PF-06863135) IN CHINESE PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY (TRIPLE-CLASS REFRACTORY MM)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
August 6, 2023 (Actual)
Study Completion Date
February 6, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elranatamab, Myeloma, Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma, PF-06863135, BCMA, 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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elranatamab
Arm Type
Experimental
Arm Description
BCMA-CD3 bispecific antibody
Intervention Type
Drug
Intervention Name(s)
Elranatamab
Other Intervention Name(s)
PF-06863135
Intervention Description
BCMA-CD3 bispecific antibody
Primary Outcome Measure Information:
Title
Phase 1b: Number of participants with dose-limiting toxicities (DLT)
Description
Number of participants with DLTs
Time Frame
Up to 4 weeks
Title
Phase 2: Objective response rate
Description
Objective response rate (IMWG response criteria)
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Duration of response
Description
Duration of response (IMWG response criteria)
Time Frame
Up to approximately 2 years
Title
Cumulative complete response rate
Description
Cumulative complete response rate (IMWG response criteria)
Time Frame
Up to approximately 2 years
Title
Duration of cumulative complete response
Description
Duration of cumulative complete response (IMWG response criteria)
Time Frame
Up to approximately 2 years
Title
Progression free survival
Description
Progression free survival (IMWG response criteria)
Time Frame
Up to approximately 2 years
Title
Overall survival (OS)
Time Frame
Up to approximately 2 years
Title
Time to response (TTR)
Description
Time to response (IMWG response criteria)
Time Frame
Up to approximately 2 years
Title
Minimal residual disease negativity rate
Description
Minimal residual disease negativity rate (IMWG response criteria)
Time Frame
Up to approximately 2 years
Title
Frequency of treatment-emergent adverse events
Description
Type and severity (including severity per NCI CTCAE v5)
Time Frame
Up to approximately 2 years
Title
Frequency of laboratory abnormalities
Description
Complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)
Time Frame
Up to approximately 2 years
Title
Serum Concentration of Elranatamab (PF-06863135)
Description
Serum concentrations of Elranatamab (PF-06863135) will be reported.
Time Frame
Up to approximately 2 years
Title
Immunogenicity of elranatamab (PF-06863135)
Description
Immunogenicity of elranatamab (anti-drug antibodies against elranatamab)
Time Frame
Up to approximately 2 years
Title
Change from Baseline in Patient-Reported Outcomes as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)
Description
The QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale.
Time Frame
Up to approximately 2 years
Title
Change from Baseline in Patient-Reported Outcomes as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire myeloma-specific module (EORTC QLQ-MY20)
Description
The EORTC MY20 is a myeloma-specific module to assess quality of life in patients with multiple myeloma. It contains 20 items which can be grouped into a disease symptom subscale (6 items), side effects of treatment subscale (10 items), body image (1 item) and future perspective subscale (3 items)
Time Frame
Up to approximately 2 years
Title
Change from Baseline in Patient-Reported Outcomes as Assessed by EuroQol Five Dimension Questionnaire (EQ-5D)
Description
The EQ-5D is a 6-item patient-completed questionnaire designed to assess health status in terms of a single index value or utility score. There are 2 components, a Health State Profile which has individuals rate their level of problems in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a VAS in which patients rate their overall health status from 0 (worst imaginable) to 100 (best imaginable).
Time Frame
Up to approximately 2 years
Title
Change from Baseline in Patient-Reported Outcomes as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ CIPN20)
Description
The EORTC QLQ CIPN20 is a module developed to assess chemotherapy-induced peripheral neuropathy. It contains 20 items which can be grouped into a sensory subscale (9 items), motor subscale (8 items) and autonomic subscale (3 items).
Time Frame
Up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510555
Country
China
Facility Name
Shenzhen Second People's Hosptial
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Facility Name
Harbin First Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150010
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
The first hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266071
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Beijing Boren Hospital
City
Beijing
ZIP/Postal Code
100070
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Hematology Hospital, Chinese Academy of Medical Sciences
City
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C1071008
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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