Full Title:

ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES

Myeloma stage or condition:

Multiple Myeloma

Study phase:

Phase 4

Summary/Purpose:

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.

Detailed Description:

This is a single-arm elranatamab post-trial access study. Participants will receive elranatamab. All participants will receive elranatamab until disease progression, unacceptable toxicity, withdrawal of consent, study termination or, elranatamab becomes commercially accessible in the participant's country.

Treatments:

Drug : Elranatamab

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

Study Arms:

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

Study Type:

Interventional

Study Design:

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Recruitment status:

Recruiting

Eligibility criteria:

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Locations / Centres:

Tom Baker Cancer Center, Calgary, Alberta – Recruiting

Cross Cancer Institute, Edmonton, Alberta – Recruiting

McGill University Health Centre, Montréal, Quebec – Recruiting

Contacts:

Name: Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Email: [email protected]

Publications:

???

First posted:

2023-09-28

Actual start date:

October 3, 2023

Last updated:

2024-02-14

Estimated enrollment:

72

Estimated completion date:

2031-02-22

Estimated primary completion date:

2031-02-22

Condition:

Multiple Myeloma

Gender:

All

Ages:

18 Years-N/A

Accepts healthy volunteers:

No

Listed location countries:

Australia

Canada

France

Japan

United States

NCT number:

NCT06057402

Other study ID numbers:

C1071015

Has Data monitoring committee:

No

U.S. FDA-regulated product:

Yes

IPD Sharing Statement :

???

Responsible party:

Sponsor

Study sponsor:

lead_sponsor
Pfizer
Industry

Collaborators:

???

Investigators:

Pfizer CT.gov Call Center Pfizer

Protocol Registration and Results System:

???

Verification date:

2024-02-01