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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of first dose up to 20.14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of first dose up to 20.14 months
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 moreTrial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Bispecific antibodies, such as Elranatamab, target CD3 on T-cells and BCMA on multiple myeloma cells, promoting T-cell-mediated cytotoxicity. This mechanism is significant as it enhances the immune system's ability to identify and kill cancer cells.
Other common treatments include proteasome inhibitors, which disrupt protein degradation in cancer cells, leading to cell death, and immunomodulatory drugs, which boost the immune response and inhibit cancer cell proliferation. These targeted therapies are crucial for multiple myeloma patients as they provide effective strategies to control and potentially eliminate the disease.
The evolving status of immunotherapies in multiple myeloma: the future role of bispecific antibodies.
The evolving status of immunotherapies in multiple myeloma: the future role of bispecific antibodies.
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,580 Previous Clinical Trials
14,634,015 Total Patients Enrolled
36 Trials studying Multiple Myeloma
9,742 Patients Enrolled for Multiple Myeloma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,485 Previous Clinical Trials
11,810,890 Total Patients Enrolled
25 Trials studying Multiple Myeloma
5,012 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with multiple myeloma.Any side effects from my previous treatments have mostly gone away.You have high levels of a certain type of protein in your blood and an abnormal ratio of two different types of proteins.I had a stem cell transplant less than 3 months ago.My condition did not improve after treatment with an IMiD.My last treatment for myeloma did not work.You have more than 200 milligrams of M-protein in your urine over a 24-hour period.You have a disease that can be measured by specific criteria.You have a high level of M-protein in your blood.My condition did not improve after treatment with an anti-CD38 antibody.I can take care of myself but might not be able to do heavy physical work.I have been diagnosed with amyloidosis.I do not have any active infections like HBV, HCV, HIV, or uncontrolled bacterial, fungal, or viral infections.My condition is smoldering multiple myeloma.I have active plasma cell leukemia.I haven't had any cancer except for certain skin cancers or localized cancer that hasn't spread in the last 3 years.I have been diagnosed with POEMS syndrome.I have not had previous treatments targeting BCMA.I have previously received BCMA-targeted therapy.My condition did not improve after using a protease inhibitor.
Research Study Groups:
This trial has the following groups:- Group 1: Elranatamab (cohort A)
- Group 2: Elranatamab (cohort B)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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