MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma

A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETIC OF PF 06863135, A B CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT IN JAPANESE PARTICIPANTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA

The purpose of this study is to confirm the safety and tolerability of elranatamab (PF-06863135) in Japanese participants with relapsed or refractory MM.

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsed or Refractory Multiple Myeloma
• Intervention / Treatment: Drug: Elranatamab (PF-06863135)

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 467-8602
      • Nagoya City University Hospital
  • Tokyo
    • Shibuya-ku, Tokyo, Japan, 150-8935
      • Japanese Red Cross Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of multiple myeloma (IMWG criteria)

• Measurable disease, as defined by at least 1 of the following

  1. Serum myeloma (M) protein ≥0.5 g/dL (5 g/L)
  2. Urine M protein ≥200 mg/24 h
  3. Serum free light chain (FLC) >100 mg/L (10 mg/dL) with abnormal kappa:lambda ratio
• Participants must have progressed on or been intolerant of at least 3 prior therapies including proteasome inhibitor, IMID drug and anti-CD38 antibody, either in combination or as a single agent
• ECOG PS 0, 1 or 2. PS 3 is permitted if PS is due solely to bone pain
• Adequate bone marrow, hematological, kidney and liver function
• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1
• Not pregnant and willing to use contraception

Exclusion Criteria:

• POEMS syndrome
• 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
• History of active autoimmune disorders
• Any form of primary immunodeficiency
• History of severe immune-mediated adverse event with prior immunomodulatory treatment
• Stem cell transplant within 12 weeks prior to enrollment
• Active graft versus host disease other than Grade 1 skin involvement, or that requiring immunosuppressive treatment
• Requirement for systemic immune suppressive medication
• Active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, known HIV or AIDS related illness and SARS-CoV2
• Previous administration with an investigational drug within 4 weeks or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
• Known or suspected hypersensitivity to component of elranatamab (PF-06863135), murine and bovine products
• Live attenuated vaccine within 4 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elranatamab (PF-06863135); BCMA-CD3 bispecific antibody	Drug: Elranatamab (PF-06863135); BCMA-CD3 bispecific antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Dose Limiting Toxicity (DLT)	Number of participants with DLTs, which are typically Grade 3 or higher adverse events	up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of treatment-emergent adverse events	type and severity (including severity per NCI CTCAE v5)	approximately 2 years
frequency of laboratory abnormalities	complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)	approximately 2 years
Maximum plasma concentration (Cmax) of PF-06863135	Peak concentration of elranatamab (PF-06863135)	4 weeks
immunogenicity of PF-06863135	Incidence and titers of anti-drug antibodies and neutralizing antibodies against elranatamab (PF-06863135)	approximately every 1 to 3 cycles (approximately 2 years)
overall response rate	overall response rate (IMWG response criteria)	approximately every 3 weeks for approximately 2 years
time to response	time to response (IMWG response criteria)	approximately every 3 weeks (approximately 2 years)
duration of response	duration of response (IMWG response criteria)	approximately every 3 weeks (approximately 2 years)
progression free survival	progression free survival (IMWG response criteria)	approximately every 3 weeks (approximately 2 years)
overall survival	overall survival	approximately every 3 months (approximately 2 years)
minimal residual disease	minimal residual disease (IMWG MRD criteria)	approximately 2 years
systemic soluble immune factors	pre and post dose quantification of soluble cytokines in serum	approximately 9 months
area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135	AUC of elranatamab (PF-06863135)	4 weeks
Trough serum concentrations of PF-06863135	Trough concentrations of (PF-06863135)	approximately 2 years

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Actual): May 27, 2022
• Study Completion (Anticipated): May 20, 2023

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: C1071002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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.

Drug and device information, study documents

• 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