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

Relapsed or Refractory Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04798586
• Other study ID #: C1071002
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 22, 2021
• Est. completion date: May 20, 2023

Study information

• Verified date: June 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: May 20, 2023
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Elranatamab (PF-06863135)
BCMA-CD3 bispecific antibody

Locations

Country	Name	City	State
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	Japanese Red Cross Medical Center	Shibuya-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	frequency of treatment-emergent adverse events	type and severity (including severity per NCI CTCAE v5)	approximately 2 years
Secondary	frequency of laboratory abnormalities	complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)	approximately 2 years
Secondary	Maximum plasma concentration (Cmax) of PF-06863135	Peak concentration of elranatamab (PF-06863135)	4 weeks
Secondary	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)
Secondary	overall response rate	overall response rate (IMWG response criteria)	approximately every 3 weeks for approximately 2 years
Secondary	time to response	time to response (IMWG response criteria)	approximately every 3 weeks (approximately 2 years)
Secondary	duration of response	duration of response (IMWG response criteria)	approximately every 3 weeks (approximately 2 years)
Secondary	progression free survival	progression free survival (IMWG response criteria)	approximately every 3 weeks (approximately 2 years)
Secondary	overall survival	overall survival	approximately every 3 months (approximately 2 years)
Secondary	minimal residual disease	minimal residual disease (IMWG MRD criteria)	approximately 2 years
Secondary	systemic soluble immune factors	pre and post dose quantification of soluble cytokines in serum	approximately 9 months
Secondary	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
Secondary	Trough serum concentrations of PF-06863135	Trough concentrations of (PF-06863135)	approximately 2 years

External Links

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