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

Multiple Myeloma Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05228470
• Other study ID #: C1071008
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 21, 2021
• Est. completion date: February 6, 2025

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: February 6, 2025
• Est. primary completion date: August 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell
• Refractory Multiple Myeloma
• Relapsed Multiple Myeloma

Intervention

Drug:
• Elranatamab
BCMA-CD3 bispecific antibody

Locations

Country	Name	City	State
China	Beijing Boren Hospital	Beijing
China	Beijing Gaobo Boren Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	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	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Harbin First Hospital	Harbin	Heilongjiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Shandong Provincial Hospital	Jinan	Shandong
China	Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Shenzhen Second People's Hosptial	Shenzhen	Guangdong
China	Hematology Hospital, Chinese Academy of Medical Sciences	Tianjin
China	Tianjin Medical University General Hospital	Tianjin
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1b: Number of participants with dose-limiting toxicities (DLT)	Number of participants with DLTs	Up to 4 weeks
Primary	Phase 2: Objective response rate	Objective response rate (IMWG response criteria)	Up to approximately 2 years
Secondary	Duration of response	Duration of response (IMWG response criteria)	Up to approximately 2 years
Secondary	Cumulative complete response rate	Cumulative complete response rate (IMWG response criteria)	Up to approximately 2 years
Secondary	Duration of cumulative complete response	Duration of cumulative complete response (IMWG response criteria)	Up to approximately 2 years
Secondary	Progression free survival	Progression free survival (IMWG response criteria)	Up to approximately 2 years
Secondary	Overall survival (OS)		Up to approximately 2 years
Secondary	Time to response (TTR)	Time to response (IMWG response criteria)	Up to approximately 2 years
Secondary	Minimal residual disease negativity rate	Minimal residual disease negativity rate (IMWG response criteria)	Up to approximately 2 years
Secondary	Frequency of treatment-emergent adverse events	Type and severity (including severity per NCI CTCAE v5)	Up to approximately 2 years
Secondary	Frequency of laboratory abnormalities	Complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)	Up to approximately 2 years
Secondary	Serum Concentration of Elranatamab (PF-06863135)	Serum concentrations of Elranatamab (PF-06863135) will be reported.	Up to approximately 2 years
Secondary	Immunogenicity of elranatamab (PF-06863135)	Immunogenicity of elranatamab (anti-drug antibodies against elranatamab)	Up to approximately 2 years
Secondary	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.	Up to approximately 2 years
Secondary	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)	Up to approximately 2 years
Secondary	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).	Up to approximately 2 years
Secondary	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).	Up to approximately 2 years

External Links

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