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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 parts 1 and 2: from start of treatment to end of the study (approximately 3 years 7 months)
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ parts 1 and 2: from start of treatment to end of the study (approximately 3 years 7 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~parts 1 and 2: from start of treatment to end of the study (approximately 3 years 7 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Grade 2 or Higher Cytokine Release Syndrome (CRS) During Cycle 1: Parts 1 and 2
Secondary study objectives
Complete Response Rate (CRR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2
Duration of Complete Response Rate (DOCR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2
Duration of Response (DOR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2
+12 moreSide effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2023
N/A
~1030
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,658 Previous Clinical Trials
17,877,197 Total Patients Enrolled
41 Trials studying Multiple Myeloma
10,572 Patients Enrolled for Multiple Myeloma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,544 Previous Clinical Trials
14,918,373 Total Patients Enrolled
29 Trials studying Multiple Myeloma
5,777 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with amyloidosis.Any side effects from my previous treatments have mostly gone away.My last treatment for myeloma did not work.I do not have any active infections like HBV, HCV, HIV, or uncontrolled bacterial, fungal, or viral infections.I have been diagnosed with POEMS syndrome.My cancer has spread to my brain or spinal cord.I have been diagnosed with Waldenström's macroglobulinemia.I have active plasma cell leukemia.My condition did not improve after treatment with specific cancer drugs.My condition is smoldering multiple myeloma.I had a stem cell transplant less than 3 months ago or I have active GVHD.I have been treated with BCMA-targeted therapy before.I haven't had any cancer except for certain skin cancers or very early stage cancers in the last 3 years.I have not received a live vaccine in the last 4 weeks.I have been diagnosed with multiple myeloma.I am fully active and can carry on all my pre-disease activities without restriction.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2C
- Group 2: Part 1
- Group 3: Part 2A
- Group 4: Part 2B
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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