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Monoclonal Antibodies
Elranatamab Combinations for Multiple Myeloma (MAGNETISMM-5 Trial)
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
Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
Prior anti-multiple myeloma therapy including treatment with lenalidomide and a proteasome inhibitor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization to date of confirmed objective response, assessed up to 51 months
Awards & highlights
MAGNETISMM-5 Trial Summary
This trial is testing a new cancer treatment combination to see if it's more effective than the current standard of care for multiple myeloma.
Who is the study for?
This trial is for adults with multiple myeloma who've had prior treatments including lenalidomide and a proteasome inhibitor. They should have measurable disease, be in relatively good health (ECOG ≤2), not pregnant, and willing to use contraception. Excluded are those with certain other conditions like amyloidosis or active infections, previous BCMA therapy, recent stem cell transplant, or live vaccines taken within the last month.Check my eligibility
What is being tested?
The study tests elranatamab alone or combined with daratumumab against a known combo of daratumumab, pomalidomide & dexamethasone in relapsed/refractory multiple myeloma patients. It's divided into parts: assessing safety and activity of different doses; comparing these treatments; evaluating alternative dosing schedules.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site, immune system-related issues such as inflammation in various organs due to antibody action, blood disorders from bone marrow suppression by chemotherapy drugs like dexamethasone and pomalidomide, infection risk increase due to immune modulation.
MAGNETISMM-5 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma.
Select...
I have been treated for multiple myeloma with lenalidomide and a proteasome inhibitor.
Select...
I can take care of myself but might not be able to do heavy physical work.
MAGNETISMM-5 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization to date of confirmed objective response, assessed up to 51 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization to date of confirmed objective response, assessed up to 51 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 Safety Lead-In: Incidence of dose limiting toxicities
Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria
Secondary outcome measures
Heart rate
Daratumumab pharmacokinetics by pre-dose concentrations
Duration of complete response per International Myeloma Working Group criteria
+15 moreMAGNETISMM-5 Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Part 2 Randomized Arm B: Elranatamab + DaratumumabExperimental Treatment2 Interventions
Group II: Part 2 Randomized Arm A: ElranatamabExperimental Treatment1 Intervention
Group III: Part 1 Safety Lead-In Dose Escalation: Elranatamab + DaratumumabExperimental Treatment2 Interventions
Group IV: Part 2 Randomized Arm C: Daratumumab + Pomalidomide + DexamethasoneActive Control3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~1860
Elranatamab
2022
N/A
~510
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,910,223 Total Patients Enrolled
35 Trials studying Multiple Myeloma
9,128 Patients Enrolled for Multiple Myeloma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,091,419 Total Patients Enrolled
25 Trials studying Multiple Myeloma
4,438 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with a BCMA-targeted therapy before.I have been diagnosed with multiple myeloma.I have been diagnosed with amyloidosis.I do not have any active infections like HBV, HCV, HIV, or uncontrolled bacterial, fungal, or viral infections.I haven't had any cancer except for certain skin cancers or localized cancer that hasn't spread in the last 3 years.You have certain levels of abnormal proteins in your blood or urine, or abnormal levels of certain proteins in your blood.I have been treated for multiple myeloma with lenalidomide and a proteasome inhibitor.I have been diagnosed with POEMS Syndrome.My condition is smoldering multiple myeloma.My side effects from previous treatments have mostly gone away.I can take care of myself but might not be able to do heavy physical work.I have not received a live vaccine in the last 4 weeks.I have been diagnosed with plasma cell leukemia.I had a stem cell transplant less than 12 weeks ago or I have active graft versus host disease.I haven't had anti-CD38 therapy in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab
- Group 2: Part 2 Randomized Arm A: Elranatamab
- Group 3: Part 2 Randomized Arm B: Elranatamab + Daratumumab
- Group 4: Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the benefits of Elranatamab?
"Elranatamab is most often utilised to treat ophthalmia, sympathetic. However, it has also shown efficacy in treating branch retinal vein occlusion, macular edema, and communicable diseases."
Answered by AI
How many different hospitals are conducting this study?
"Seven recruitment sites for this clinical trial have been announced, they are: Tom Baker Cancer Center in Calgary, Cross Cancer Institute in Edmonton, QEII Health Sciences Centre - Victoria General Site in Toronto. Plus, there are seven other locations where patients can be recruited."
Answered by AI
What are the potential risks associated with Elranatamab?
"Elranatamab is in Phase 3 of clinical trials, thus there is some efficacy data as well as multiple rounds of safety data, leading to a Power team estimation of 3."
Answered by AI
What is the target recruitment for this research project?
"589 patients that meet the clinical trial's requirements are necessary to carry out this experiment. The sponsor, Pfizer, will be managing the trial from various locations; two in Alberta (Tom Baker Cancer Center & Cross Cancer Institute) and one in Ontario."
Answered by AI
What are other researchers saying about Elranatamab?
"Elranatamab was first studied in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Out of the 1201 completed clinical trials, there are presently 683 active trials. The majority of these studies are based out of Calgary, Alberta."
Answered by AI
Are patients currently being sought for this experiment?
"That is correct. The listing on clinicaltrials.gov says that the trial is recruiting patients as we speak. This research was first made public on October 4th, 2021 and was last updated 19 days ago. 589 individuals are needed to participate at 7 separate locations."
Answered by AI
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