Clinical Trials /

Study of PF-06863135 Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb

NCT04649359

Description:

The purpose of the study is to evaluate whether single-agent PF-06863135 can provide clinical benefit in participants with relapsed/refractory multiple myeloma. PF-06863135 is a bispecific antibody: binding of PF-06863135 to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of PF-06863135 Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb
  • Official Title: AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF PF-06863135 MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY

Clinical Trial IDs

  • ORG STUDY ID: C1071003
  • NCT ID: NCT04649359

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
PF-06863135PF-06863135 (cohort A)

Purpose

The purpose of the study is to evaluate whether single-agent PF-06863135 can provide clinical benefit in participants with relapsed/refractory multiple myeloma. PF-06863135 is a bispecific antibody: binding of PF-06863135 to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

Trial Arms

NameTypeDescriptionInterventions
PF-06863135 (cohort A)ExperimentalBCMA-CD3 bispecific antibody
  • PF-06863135
PF-06863135 (cohort B)ExperimentalBCMA-CD3 bispecific antibody
  • PF-06863135

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)

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

               1. Serum M-protein >0.5 g/dL by SPEP

               2. Urinary M-protein excretion >200 mg/24 hours by UPEP

               3. 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

          -  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

          -  Plasma cell leukemia

          -  Light chain amyloidosis

          -  Active HBV, HCV, SARS-CoV2, known 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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:16 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:objective response rate
Time Frame:assessed approximately every 4 weeks [up to approximately 2 years]
Safety Issue:
Description:objective response rate (IMWG response criteria)

Secondary Outcome Measures

Measure:duration of response
Time Frame:assessed approximately every 4 weeks [up to approximately 2 years]
Safety Issue:
Description:duration of response (IMWG response criteria)
Measure:cumulative complete response rate
Time Frame:assessed approximately every 4 weeks [up to approximately 2 years]
Safety Issue:
Description:cumulative complete response rate (IMWG response criteria)
Measure:duration of cumulative complete response
Time Frame:assessed approximately every 4 weeks [up to approximately 2 years]
Safety Issue:
Description:duration of cumulative complete response (IMWG response criteria)
Measure:progression free survival
Time Frame:assessed approximately every 4 weeks [up to approximately 2 years]
Safety Issue:
Description:progression free survival (IMWG response criteria)
Measure:time to response
Time Frame:assessed approximately every 4 weeks [up to approximately 2 years]
Safety Issue:
Description:time to response (IMWG response criteria)
Measure:minimal residual disease negativity rate
Time Frame:assessed approximately every 12 months [up to approximately 2 years]
Safety Issue:
Description:minimal residual disease negativity rate (IMWG response criteria)
Measure:frequency of treatment-emergent adverse events
Time Frame:up to approximately 2 years
Safety Issue:
Description:type and severity (including severity per NCI CTCAE v5)
Measure:frequency of laboratory abnormalities
Time Frame:assessed at least approximately every cycle [each cycle approximately 28 days]
Safety Issue:
Description:complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)
Measure:concentrations of PF-06863135
Time Frame:assessed approximately every 1 to 3 cycles [each cycle approximately 28 days]
Safety Issue:
Description:pharmacokinetics of PF-06863135
Measure:immunogenicity of PF-06863135
Time Frame:assessed approximately every 1 to 3 cycles [each cycle approximately 28 days]
Safety Issue:
Description:immunogenicity of PF-06863135 (anti-drug antibodies against PF-06863135)
Measure:overall survival
Time Frame:up to approximately 5 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Pfizer

Trial Keywords

  • Elemmental-3
  • Elemmental
  • Myeloma
  • Multiple Myeloma
  • relapsed Multiple Myeloma
  • refractory Multiple Myeloma
  • PF-06863135
  • BCMA
  • bispecific
  • bispecific antibody
  • BCMA-CD3 bispecific

Last Updated

December 2, 2020