MagnetisMM-8: Study Of Elranatamab (PF-06863135) Monotherapy in Chinese Participants With Refractory Multiple Myeloma

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05228470

Collaborator

(none)

Enrollment

Locations

Arm

37.5

Anticipated Duration (Months)

1.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study C1071008 includes 2 parts. The objective of Phase 1b part is to establish the safety profile in order to confirm the monotherapy RP2D in Chinese participants. The Phase 2 part is a single stage design to evaluate the efficacy and safety in Chinese participants. Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

Condition or Disease	Intervention/Treatment	Phase
Elranatamab Myeloma Multiple Myeloma Relapsed Multiple Myeloma Refractory Multiple Myeloma PF-06863135 BCMA Bispecific Bispecific Antibody BCMA-CD3 Bispecific MagnetisMM-8	Drug: Elranatamab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Dec 21, 2021

Anticipated Primary Completion Date :

Aug 9, 2023

Anticipated Study Completion Date :

Feb 5, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Elranatamab BCMA-CD3 bispecific antibody	Drug: Elranatamab BCMA-CD3 bispecific antibody Other Names: PF-06863135

Arm

Intervention/Treatment

Experimental: Elranatamab

BCMA-CD3 bispecific antibody

Drug: Elranatamab

BCMA-CD3 bispecific antibody

Other Names:

PF-06863135

Outcome Measures

Primary Outcome Measures

Phase 1b: Number of participants with dose-limiting toxicities (DLT) [Up to 4 weeks]
Number of participants with DLTs
Phase 2: Objective response rate [Up to approximately 2 years]
Objective response rate (IMWG response criteria)

Secondary Outcome Measures

Duration of response [Up to approximately 2 years]
Duration of response (IMWG response criteria)
Cumulative complete response rate [Up to approximately 2 years]
Cumulative complete response rate (IMWG response criteria)
Duration of cumulative complete response [Up to approximately 2 years]
Duration of cumulative complete response (IMWG response criteria)
Progression free survival [Up to approximately 2 years]
Progression free survival (IMWG response criteria)
Overall survival (OS) [Up to approximately 2 years]
Time to response (TTR) [Up to approximately 2 years]
Time to response (IMWG response criteria)
Minimal residual disease negativity rate [Up to approximately 2 years]
Minimal residual disease negativity rate (IMWG response criteria)
Frequency of treatment-emergent adverse events [Up to approximately 2 years]
Type and severity (including severity per NCI CTCAE v5)
Frequency of laboratory abnormalities [Up to approximately 2 years]
Complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)
Serum Concentration of Elranatamab (PF-06863135) [Up to approximately 2 years]
Serum concentrations of Elranatamab (PF-06863135) will be reported.
Immunogenicity of elranatamab (PF-06863135) [Up to approximately 2 years]
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) [Up to approximately 2 years]
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) [Up to approximately 2 years]
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) [Up to approximately 2 years]
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) [Up to approximately 2 years]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Shenzhen Second People's Hosptial	Shenzhen	Guangdong	China	518035
6	Harbin First Hospital	Harbin	Heilongjiang	China	150010
7	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	China	150081
8	Henan Cancer Hospital	Zhengzhou	Henan	China	450008
9	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China
10	Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210008
11	Shandong Provincial Hospital	Jinan	Shandong	China	250021
12	The Affiliated Hospital of Qingdao University	Qingdao	Shandong	China	266071
13	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310003
14	Peking Union Medical College Hospital	Beijing		China	100032
15	Beijing Boren Hospital	Beijing		China	100070
16	Peking University Third Hospital	Beijing		China	100191
17	Peking Union Medical College Hospital	Beijing		China	100730
18	Hematology Hospital, Chinese Academy of Medical Sciences	Tianjin		China	300020
19	Tianjin Medical University General Hospital	Tianjin		China	300052