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Monoclonal Antibodies

Elranatamab +/- Dexamethasone for Multiple Myeloma (MagnetisMM-9 Trial)

Phase 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

MagnetisMM-9 Trial Summary

This trial is testing the safety of a new dosing method for a medication used to treat myeloma. The study will also look at how effective the medication is at different doses and how often it should be given.

Who is the study for?

This trial is for adults with multiple myeloma that has returned or didn't respond to treatment. They must have measurable disease, not be pregnant, and agree to use contraception. Excluded are those with certain other cancers or conditions like active infections, recent stem cell transplant, previous anti-BCMA therapy, or known hypersensitivity to the study drugs.Check my eligibility

What is being tested?

The trial tests Elranatamab alone or combined with Dexamethasone in patients with relapsed/refractory multiple myeloma. It starts with low doses that increase over time (step-up dosing) and looks at safety and effectiveness of different doses and dose intervals over a minimum two-year participation.See study design

What are the potential side effects?

While specific side effects aren't listed here, participants can expect potential reactions at injection sites, effects from immune system activation such as inflammation in various organs, changes in blood counts leading to increased infection risk or bleeding tendencies, fatigue, bone pain related to their condition.

MagnetisMM-9 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS) (Part 1 and 2)

Secondary outcome measures

Complete Response Rate

Duration of complete response rate

Duration of response

+10 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

MagnetisMM-9 Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2CExperimental Treatment1 Intervention

To explore higher dose intensity

Group II: Part 2BExperimental Treatment1 Intervention

Dose expansion

Group III: Part 2AExperimental Treatment1 Intervention

Dose determination

Group IV: Part 1Experimental Treatment1 Intervention

Evaluation of step-up priming dosing

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elranatamab

2022

N/A

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,911,788 Total Patients Enrolled

35 Trials studying Multiple Myeloma

9,297 Patients Enrolled for Multiple Myeloma

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,092,956 Total Patients Enrolled

25 Trials studying Multiple Myeloma

4,607 Patients Enrolled for Multiple Myeloma

Media Library

Elranatamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05014412 — Phase 2

Multiple Myeloma Research Study Groups: Part 2C, Part 1, Part 2A, Part 2B

Multiple Myeloma Clinical Trial 2023: Elranatamab Highlights & Side Effects. Trial Name: NCT05014412 — Phase 2

Elranatamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05014412 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In which areas can individuals access this clinical trial?

"34 medical centres are currently recruiting for this study, including Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy in Long Island City, MSK Westchester in Harrison, and MSK Basking Ridge in Basking Ridge. Multiple other locations also have enrolment spots available."

Answered by AI

How many individuals are participating in this medical research?

"Affirmative. Details on clinicaltrials.gov support that this medical trial is open for recruitment, with the original posting date of October 7th 2021 and most recent update dated November 21st 2022. 76 participants from 34 different sites are needed to complete this experiment."

Answered by AI

To what extent could Elranatamab be hazardous to human health?

"After thorough evaluation, we have determined that Elranatamab is a safe enough medication to receive an assessment of 2. This rating accounts for Phase 2 trial results which demonstrate safety but lack evidence in support of efficacy."

Answered by AI

Are there any opportunities for individuals to participate in this experiment?

"Affirmative. According to details on clinicaltrials.gov, this trial is actively seeking applicants; it was first listed on October 7th 2021 and has recently been updated as of November 21st 2022. The study is currently enrolling 76 people at 34 centers around the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment

2021. "A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05014412.