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Bispecific Antibody

Elranatamab for Multiple Myeloma

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
Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
Refractory to at least one IMiD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of first dose up to 20.14 months
Awards & highlights

Study Summary

This trial will test whether Elranatamab can provide clinical benefit in people with relapsed/refractory multiple myeloma by targeting and killing myeloma cells.

Who is the study for?
This trial is for adults with multiple myeloma who haven't responded to at least one proteasome inhibitor (PI), one immunomodulatory drug (IMiD), and one anti-CD38 antibody. Participants should have measurable disease, be in stable condition, not pregnant, willing to use contraception, and without other active cancers or serious infections. There are two groups: those who've had BCMA-targeted therapy before and those who haven't.Check my eligibility
What is being tested?
The study tests Elranatamab as a single treatment for relapsed/refractory multiple myeloma. It's a bispecific antibody that directs the body's T-cells to attack the cancer cells by recognizing both T-cell markers (CD3) and myeloma cell markers (BCMA). The goal is to see if this targeted approach can help control the disease.See study design
What are the potential side effects?
Potential side effects of Elranatamab may include symptoms related to immune system activation such as fever, fatigue, infusion reactions where the medication enters the body, possible damage to healthy cells leading to low blood counts or organ dysfunction. Specific side effect profiles will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with multiple myeloma.
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My condition did not improve after treatment with an IMiD.
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My last treatment for myeloma did not work.
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My condition did not improve after treatment with an anti-CD38 antibody.
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I can take care of myself but might not be able to do heavy physical work.
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I have not had previous treatments targeting BCMA.
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I have previously received BCMA-targeted therapy.
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My condition did not improve after using a protease inhibitor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of first dose up to 20.14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dose up to 20.14 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria
Secondary outcome measures
Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants With Extramedullary Disease (EMD) at Baseline
Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants Without EMD at Baseline
Complete Response Rate (CRR) as Per IMWG Criteria by BICR
+18 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Elranatamab (cohort B)Experimental Treatment1 Intervention
BCMA-CD3 bispecific antibody
Group II: Elranatamab (cohort A)Experimental Treatment1 Intervention
BCMA-CD3 bispecific antibody

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,685 Total Patients Enrolled
35 Trials studying Multiple Myeloma
9,195 Patients Enrolled for Multiple Myeloma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,853 Total Patients Enrolled
25 Trials studying Multiple Myeloma
4,505 Patients Enrolled for Multiple Myeloma

Media Library

Elranatamab (PF-06863135) (Bispecific Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT04649359 — Phase 2
Multiple Myeloma Research Study Groups: Elranatamab (cohort A), Elranatamab (cohort B)
Multiple Myeloma Clinical Trial 2023: Elranatamab (PF-06863135) Highlights & Side Effects. Trial Name: NCT04649359 — Phase 2
Elranatamab (PF-06863135) (Bispecific Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04649359 — Phase 2

Frequently Asked Questions

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

What prior investigations have been conducted using Elranatamab (PF-06863135)?

"Currently, 5 Elranatamab (PF-06863135) clinical studies are in progress with one trial being conducted during Phase 3. While a majority of these investigations take place around Sendai, Miyagi; there is also a multitude of 373 different medical centres across the globe conducting research for Elranatamab (PF-06863135)."

Answered by AI

How many individuals are currently participating in this clinical experiment?

"Currently, this research is not enrolling new participants. The trial was launched on February 2nd 2021 and had its last update in October 4th 2022. If you are seeking other trials related to multiple myeloma, 807 studies are actively recruiting patients as well as 5 clinicals for Elranatamab (PF-06863135)."

Answered by AI

How many healthcare facilities are participating in this clinical investigation?

"This clinical trial is being conducted in the Prisma Health Cancer Institute located in Greenville, South carolina; The Ohio State University Wexner Medical Center based out of New Orleans, Louisiana; and Ochsner Medical Center ? Jefferson Highway situated in Nashville, Tennessee. Additionally, there are 20 other places taking part as well."

Answered by AI

Are there any vacancies open for prospective participants of this trial?

"This clinical trial is not open to recruitment at the moment. Its initial post date was February 2nd 2021 and it has been revised on October 4th 2022. If you wish to look for other trials, 807 studies related to multiple myeloma are actively accepting patients whilst 5 trials concerning Elranatamab (PF-06863135) are currently enrolling participants."

Answered by AI

Is this study a fresh approach to treatment?

"Since 2017, Elranatamab (PF-06863135) has been investigated in both lab and clinical settings. Pfizer was the first to sponsor a trial with 103 participants which resulted in its Phase 1 drug approval. Currently, there are 5 ongoing investigations of this medication across 143 cities and 26 countries worldwide."

Answered by AI

What has been observed with regards to the safety of Elranatamab (PF-06863135) for patients?

"As this is a Phase 2 medical trial with some safety evidence but no proof of efficacy, Elranatamab (PF-06863135) was assessed at level 2 on the safety scale."

Answered by AI
~45 spots leftby Apr 2025