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Monoclonal Antibodies

Elranatamab for Multiple Myeloma

Phase 3

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.

Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria

Must not have

Any active, uncontrolled bacterial, fungal, or viral infection

Unable to receive investigator's choice therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

"This trial is testing a new medication called elranatamab for the treatment of a type of cancer called MM. Participants in the trial must be 18 years or older with MM that has returned

Who is the study for?

This trial is for adults with Multiple Myeloma (MM) that has returned or hasn't responded after treatment, including anti-CD38 antibody and lenalidomide. Participants must have had 1 to 4 prior MM treatments, meet specific lab value criteria, not be pregnant or breastfeeding, and agree to use contraception.

What is being tested?

The study compares elranatamab—a new medication given as a weekly shot—with a combination of standard MM therapies chosen by the doctor. The goal is to evaluate elranatamab's safety and effectiveness against these common treatments.

What are the potential side effects?

Potential side effects are not specified in the provided information but may include reactions at the injection site, general drug-related side effects like nausea, fatigue, blood disorders, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My last cancer treatment did not work according to IMWG standards.

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My last cancer treatment did not work as expected.

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I can take care of myself and am up and about more than half of my waking hours.

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I have multiple myeloma and have been treated 1-4 times, including with CD38 antibody and lenalidomide.

Select...

I can take care of myself but might not be able to do heavy physical work.

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I have multiple myeloma and have been treated with 1-4 therapies, including CD38 antibody and lenalidomide.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any ongoing serious infections.

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I cannot undergo the standard treatment recommended by my doctor.

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My condition is smoldering multiple myeloma.

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I have been diagnosed with POEMS syndrome.

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My cancer has spread to my brain or spinal cord.

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I have been diagnosed with plasma cell leukemia.

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I have been diagnosed with amyloidosis.

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I had a stem cell transplant less than 12 weeks ago or I have active graft versus host disease.

Select...

I have been treated with BCMA or CD3-targeting therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival per International Myeloma Working Group criteria

Secondary study objectives

Complete response rate per International Myeloma Working Group criteria

Duration of complete response per International Myeloma Working Group criteria

Duration of minimal residual disease negativity rate per International Myeloma Working Group criteria

+10 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ElranatamabExperimental Treatment1 Intervention

Participants will receive elranatamab monotherapy

Group II: Investigator's ChoiceActive Control5 Interventions

Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elranatamab

2023

N/A

~1030

0 / 15Eligibility criteria met