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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-03

Study Completion Date

2032-02-22

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Keywords

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Multiple Myeloma Elranatamab Post Trial Access Roll-over Study Extension Study MM-15 MagnetisMM15 BCMA BCMA antibody Magnetism Bispecific antibody Elrexfio

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Elranatamab

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

Group Type EXPERIMENTAL

Elranatamab

Intervention Type DRUG

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

Interventions

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Elranatamab

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

Intervention Type DRUG

Other Intervention Names

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Elrexfio

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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UCHealth Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status RECRUITING

UCHealth Harmony

Fort Collins, Colorado, United States

Site Status RECRUITING

UCHealth Greeley Hospital

Greeley, Colorado, United States

Site Status RECRUITING

Longs Peak Hospital

Longmont, Colorado, United States

Site Status RECRUITING

UCHealth Longs Peak Medical Center

Longmont, Colorado, United States

Site Status RECRUITING

UCHealth - Medical Center of the Rockies

Loveland, Colorado, United States

Site Status RECRUITING