ACTIVE_NOT_RECRUITING

MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma

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Conditions

Multiple MyelomaPF-06863135, Multiple Myeloma, BCMA, elranatamab, bispecific antibody, MagnetisMM-4

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.

Official Title

A PHASE 1B/2, OPEN LABEL UMBRELLA STUDY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, IN COMBINATION WITH OTHER ANTI-CANCER TREATMENTS IN PARTICIPANTS WITH MULTIPLE MYELOMA

Quick Facts

Study Start:2021-10-27
Study Completion:2026-02-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05090566

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy
  2. * Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody
  3. * Measurable disease defined by at least one of the following:
  4. 1. Serum M-protein \>/= 0.5 g/dL by SPEP
  5. 2. Urinary M-protein excretion \>/= 200 mg/24 hours by UPEP
  6. 3. Serum immunoglobulin FLC \>/= 10 mg/dL (\>/= 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
  7. * ECOG performance status 0 -1
  8. * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade \</= 1
  1. * Active plasma cell leukemia
  2. * Amyloidosis
  3. * Stem cell transplant with 12 weeks prior to enrollment, or active GVHD
  4. * POEMS syndrome
  5. * Any active uncontrolled bacterial, fungal, or viral infection
  6. * Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment
  7. * Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer)
  8. * Sub-Study A Only: Previous treatment with BCMA bispecific antibody
  9. * Sub-Study B Only: Previous treatment with BCMA directed therapy

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Banner Gateway Medical Center
Gilbert, Arizona, 85234
United States
Banner Gateway Medical Pavilion
Gilbert, Arizona, 85234
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
University of Arkansas for Medical Sciences - Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, 72205
United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211
United States
Clinical Research Advisors
Encino, California, 91316
United States
Clinical Research Advisors
Los Angeles, California, 90020
United States
Cedars Sinai Medical Center Oncology IDS Pharmacy Attn:Suwicha Limvorasak ,PharmaD
Los Angeles, California, 90048
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI)
Los Angeles, California, 90048
United States
Clinical Research Advisors
Los Angeles, California, 90048
United States
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Coral Gables, Florida, 33146
United States
Sylvester Comprehensive Cancer Center- Deerfield Beach
Deerfield Beach, Florida, 33442
United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
UHealth Tower
Miami, Florida, 33136
United States
UChicago Medicine - River East
Chicago, Illinois, 60611
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
UChicago Medicine at Ingalls - Flossmoor
Flossmoor, Illinois, 60422
United States
UChicago Medicine Ingalls Memorial
Harvey, Illinois, 60426
United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, 60451
United States
The University of Chicago Medicine Center for Advanced Care Orland Park
Orland Park, Illinois, 60462
United States
UChicago Medicine at Ingalls - Tinley Park
Tinley Park, Illinois, 60477
United States
OIDS, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Also Imaging Facility)
Baltimore, Maryland, 21231
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-27
Study Completion Date2026-02-19

Study Record Updates

Study Start Date2021-10-27
Study Completion Date2026-02-19

Terms related to this study

Keywords Provided by Researchers

  • PF-06863135, Multiple Myeloma, BCMA, elranatamab, bispecific antibody, MagnetisMM-4

Additional Relevant MeSH Terms

  • Multiple Myeloma