NCT06057402

Brief Summary

This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4 multiple-myeloma

Timeline
67mo left

Started Oct 2023

Longer than P75 for phase_4 multiple-myeloma

Geographic Reach
7 countries

33 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Oct 2023Feb 2032

First Submitted

Initial submission to the registry

September 5, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

October 3, 2023

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2032

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

8.4 years

First QC Date

September 5, 2023

Last Update Submit

June 29, 2026

Conditions

Keywords

Multiple MyelomaElranatamabPost Trial AccessRoll-over StudyExtension StudyMM-15MagnetisMM15BCMABCMA antibodyMagnetismBispecific antibodyElrexfio

Outcome Measures

Primary Outcomes (2)

  • Incidence of nonserious adverse events (AEs) leading to permanent discontinuation

    A minimum of 90 days after the last dose of study drug

  • Incidence of serious adverse events (SAEs)

    A minimum of 90 days after the last dose of study drug

Study Arms (1)

Elranatamab

EXPERIMENTAL

Elranatamab is a heterodimeric humanized full length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells

Drug: Elranatamab

Interventions

Elranatamab is a heterodimeric humanized full-length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells

Also known as: Elrexfio
Elranatamab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must agree to follow the reproductive criteria as outlined in the protocol
  • Participants have completed a qualifying Parent Study, were still receiving elranatamab when the Parent Study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator).

You may not qualify if:

  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

UCI Health - Irvine Infusion Pharmacy ACC

Irvine, California, 92612, United States

RECRUITING

UC Irvine Health

Orange, California, 92612, United States

RECRUITING

UCI Health

Orange, California, 92868, United States

RECRUITING

UCHealth Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

RECRUITING

UCHealth Harmony

Fort Collins, Colorado, 80528, United States

RECRUITING

UCHealth Greeley Hospital

Greeley, Colorado, 80634, United States

RECRUITING

Longs Peak Hospital

Longmont, Colorado, 80504, United States

RECRUITING

UCHealth Longs Peak Medical Center

Longmont, Colorado, 80504, United States

RECRUITING

UCHealth - Medical Center of the Rockies

Loveland, Colorado, 80538, United States

RECRUITING

Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

Coral Gables, Florida, 33146, United States

RECRUITING

University of Miami Hospital and Clinics Deerfield Beach

Deerfield Beach, Florida, 33442, United States

RECRUITING

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

RECRUITING

University of Miami Hospital and Clinics - Griffin Cancer Research Building

Miami, Florida, 33136, United States

RECRUITING

University of Miami Hospital and Clinics

Miami, Florida, 33136, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)

Detroit, Michigan, 48202, United States

RECRUITING

St. David's South Austin Medical Center

Austin, Texas, 78704, United States

RECRUITING

Epworth Freemasons

Melbourne, Victoria, 3002, Australia

RECRUITING

Epworth Hospital

Richmond, Victoria, 3121, Australia

RECRUITING

Slade Pharmacy

Richmond, Victoria, 3121, Australia

RECRUITING

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5GN, Canada

RECRUITING

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

ACTIVE NOT RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510555, China

ACTIVE NOT RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

RECRUITING

The first Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, 150-8935, Japan

RECRUITING

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

RECRUITING

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario Doctor Peset

Valencia, València, 46017, Spain

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 28, 2023

Study Start

October 3, 2023

Primary Completion (Estimated)

February 22, 2032

Study Completion (Estimated)

February 22, 2032

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations