Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. 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.

Official Title

MAGNETISMM-3 AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF ELRANATAMAB (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

Keywords

Multiple Myeloma Myeloma relapsed Multiple Myeloma refractory Multiple Myeloma PF-06863135 BCMA bispecific bispecific antibody BCMA-CD3 bispecific Elranatamab MagnetisMM-3 Neoplasms, Plasma Cell Elranatamab (PF-06863135)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 by SPEP
  • Urinary M-protein excretion >200 mg/24 hours by UPEP
  • 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
  • Cohort A: has not received prior BCMA-directed therapy
  • Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells)
  • 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

You CAN'T join if...

  • Smoldering multiple myeloma
  • Active Plasma cell leukemia
  • Amyloidosis
  • POEMS syndrome
  • Stem cell transplant within 12 weeks prior to enrollment
  • 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)

Locations

  • UC Irvine Health - Chao Family Comprehensive Cancer Center not yet accepting patients
    Orange California 92868-3201 United States
  • UCLA Hematology/Oncology Clinic accepting new patients
    Los Angeles California 90095 United States
  • UCLA Ronald Reagan Medical Center accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT04649359
Phase
Phase 2
Study Type
Interventional
Last Updated