Clinical Trials /

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

NCT04798586

Description:

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

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma
  • Official Title: MAGNETISMM-2: A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETIC OF ELRANATAMAB (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 IDs

  • ORG STUDY ID: C1071002
  • NCT ID: NCT04798586

Conditions

  • Relapsed or Refractory Multiple Myeloma

Interventions

DrugSynonymsArms
Elranatamab (PF-06863135)Elranatamab (PF-06863135)

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Elranatamab (PF-06863135)ExperimentalBCMA-CD3 bispecific antibody
  • Elranatamab (PF-06863135)

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Pfizer

Last Updated

August 23, 2021