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

PHASE4RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-10-03

Primary completion: 2031-02-22

Study completion finish: 2031-02-22

Study type

TREATMENT

Phase

PHASE4

Trial ID

NCT06057402

Intervention or treatment

DRUG: Elranatamab

Conditions

• Multiple Myeloma

Condition: Multiple Myeloma
DRUG: Elranatamab
Melbourne, Victoria, Australia and more
Sponsor: Pfizer

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Epworth Freemasons

Research sites nearby

Select from list below to view details:

Epworth Freemasons
Melbourne, Victoria, Australia
Epworth Hospital
Richmond, Victoria, Australia
Slade Pharmacy
Richmond, Victoria, Australia

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?

Participant Group/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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence of nonserious adverse events (AEs) leading to permanent discontinuation	Not Specified	A minimum of 90 days after the last dose of study drug
Incidence of serious adverse events (SAEs)	Not Specified	A minimum of 90 days after the last dose of study drug

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)