MagnetisMM15: Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06057402

Collaborator

(none)

Enrollment

Location

Arm

88.9

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Elranatamab	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Elranatamab Post Trial Access: an Open-label, Single-arm Study for Participants With Multiple Myeloma Continuing From Pfizer-Sponsored Erlanatamab Clinical Studies

Anticipated Study Start Date :

Sep 26, 2023

Anticipated Primary Completion Date :

Feb 22, 2031

Anticipated Study Completion Date :

Feb 22, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Elranatamab Elranatamab is a heterodimeric humanized full length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells	Drug: Elranatamab Elranatamab is a heterodimeric humanized full-length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells Other Names: Elrexfio

Arm

Intervention/Treatment

Experimental: Elranatamab

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

Drug: Elranatamab

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

Other Names:

Elrexfio

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.