Elranatamab Expanded Access Protocol in Adults With Relapsed/Refractory Multiple Myeloma (MAGNETISMM17)

August 6, 2024 updated by: Pfizer

ELRANATAMAB (PF-06863135) MONOTHERAPY EXPANDED ACCESS PROTOCOL FOR TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY AND HAVE NO ACCESS TO OTHER COMPARABLE/ALTERNATIVE THERAPY

Elranatamab is a bispecific antibody: binding of elranatamab to CD3- expressing T-cell and BCMA- expressing multiple myeloma cells causes targeted T-cell mediated cytotoxicity.

This expanded access protocol will provide access to elranatamab until it becomes commercially accessible to patients who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody and have no access to other comparable/alternative therapy and for whom elranatamab could be a possible treatment option.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

Study C1071017 is a single-arm, open-label study in patient with relapsed /refractory multiple myeloma.

Each patient will receive study intervention until disease progression, unacceptable toxicity, withdrawal of consent, study termination or until elranatamab becomes commercially accessible.

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
      • Orange, California, United States, 92868
        • UC Irvine Medical Center
      • Orange, California, United States, 92868
        • UC Irvine Health
    • Florida
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Cancer Institute at Memorial Hospital West
      • Pembroke Pines, Florida, United States, 33021
        • Memorial Cancer Institute at Memorial Hospital West
      • Pembroke Pines, Florida, United States, 33026
        • Memorial Cancer Institute at Memorial Hospital West
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Hospital West Laboratory Services
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Blood and Marrow Transplant Group of Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Augusta, Georgia, United States, 30912
        • Georgia Cancer Center at Augusta University
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Health
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
      • Jackson, Mississippi, United States, 39213
        • University of Mississippi Medical Center
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • MSK Basking Ridge
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
      • Middletown, New Jersey, United States, 07748
        • MSK Monmouth
      • Montvale, New Jersey, United States, 07645
        • MSK Bergen
    • New York
      • Commack, New York, United States, 11725
        • MSK Commack
      • Harrison, New York, United States, 10604
        • MSK Westchester
      • Long Island City, New York, United States, 11101
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
      • Uniondale, New York, United States, 11553
        • MSK Nassau
    • Ohio
      • Columbus, Ohio, United States, 43214
        • OhioHealth Research Institute
      • Columbus, Ohio, United States, 43214
        • OhioHealth Arthur G.H. Bing, MD Cancer Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Dallas, Texas, United States, 75246
        • Texas Oncology
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Prior diagnosis of MM as defined according to IMWG criteria .
  • Patients who are ineligible for participation in any ongoing clinical trial of elranatamab, including lack of access due to geographical limitations, and who have exhausted all other treatment options or experience lack of access to commercially available therapies due to geographical, financial or socioeconomic limitations.
  • Measurable disease at screening based on IMWG criteria as defined by at least 1 of the following:
  • Serum M-protein ≥0.5 g/dL (≥5 g/L)
  • Urinary M-protein excretion ≥200 mg/24 hours
  • Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
  • Refractory to at least one IMiD, one PI, and one anti-CD38 antibody.
  • Relapsed/refractory to last anti-MM regimen.
  • ECOG performance status 0-1.
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
  • Not pregnant, willing to use contraception

Exclusion Criteria:

  • Smoldering MM; plasma cell leukemia; POEMS syndrome; Waldenström's macroglobulinemia; amyloidosis; stem cell transplant within 12 weeks prior to enrollment or active GVHD
  • Previous treatment with BCMA directed therapy;
  • Active HBV, HCV, SARS- CoV-2, HIV or any active, uncontrolled bacterial, fungal, or viral infection.

Active infections must be resolved at least 14 days prior to enrollment.

  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ or Stage 0/1 with minimal risk of recurrence per treating physician.
  • Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start

December 7, 2022

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

July 15, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1071017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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