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Proteasome Inhibitor
Combination Therapy for Multiple Myeloma (MagnetisMM-20 Trial)
Phase 1
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
Part 2: Received at least 3 prior lines of therapy for multiple myeloma who are refractory to at least one IMiD, one PI and one anti-CD38 antibody
Timeline
Screening 3 weeks
Treatment Varies
Follow Up accessed from baseline up to 90 days after the last dose of study treatment.
Awards & highlights
MagnetisMM-20 Trial Summary
This trial is testing a combo of medicines to treat multiple myeloma, a form of cancer in the bone, in people 18+ who have received 1-3 lines of therapy. Meds will be given for 2 yrs & monitored for safety.
Who is the study for?
This trial is for people with relapsed refractory multiple myeloma who've had prior treatments. Part 1 participants can have had 1-3 prior therapies and must not be pregnant, breastfeeding, or have used BCMA-directed therapy before. Part 2 requires at least 3 previous lines of treatment and no recent anti-BCMA or CD47-SIRP alpha-directed therapies (except CAR-T). All must meet specific disease measurement criteria and not have certain heart conditions or active infections.Check my eligibility
What is being tested?
The study tests the safety of combining elranatamab with carfilzomib plus dexamethasone (Part 1) or maplirpacept (Part 2). It's divided into two parts: first to assess safety/tolerability of the combination treatments, second to find the best dose. Treatments are given in cycles over approximately two years, involving shots under the skin and IV infusions.See study design
What are the potential side effects?
Potential side effects may include reactions at injection sites, effects from immune system activation like inflammation in various organs, blood disorders, increased risk of infections due to lowered immunity, fatigue from treatment regimens, as well as possible cardiovascular issues related to carfilzomib.
MagnetisMM-20 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 had 3 or more treatments for my multiple myeloma and none worked well.
Select...
I am fully active or can carry out light work.
MagnetisMM-20 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed from baseline up to 90 days after last dose of study treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from baseline up to 90 days after last dose of study treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 Number of participants with dose limiting toxicity (DLT)
Part 2A Number of participants with dose limiting toxicity
Part 2B Number of participants with dose limiting Toxicity
Secondary outcome measures
Part 1: Concentrations of carfilzomib
Part 1: Concentrations of elranatamab
Part 1: Duration of Complete Response (DOCR)
+44 moreMagnetisMM-20 Trial Design
3Treatment groups
Experimental Treatment
Group I: Part 2B Dose RandomizationExperimental Treatment2 Interventions
Randomized dose level Elranatamab plus Maplirpacept
Group II: Part 2A Dose EscalationExperimental Treatment2 Interventions
Non randomized Elranatamab plus Maplirpacept
Group III: Part 1 Dose EscalationExperimental Treatment2 Interventions
Non randomized Elranatamab plus Carfilzomib and Dexamethasone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elranatamab
2022
N/A
~510
Carfilzomib
2017
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,972 Total Patients Enrolled
35 Trials studying Multiple Myeloma
9,876 Patients Enrolled for Multiple Myeloma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,092,167 Total Patients Enrolled
25 Trials studying Multiple Myeloma
5,186 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any ongoing serious infections.I had a stem cell transplant less than 3 months ago or I have ongoing graft versus host disease.I have been treated with a BCMA-targeted therapy before.I cannot take carfilzomib because it may cause heart issues or blood vessel problems.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 treated with anti-BCMA therapy but not CAR-T, and have used CD47-SIRP alpha therapy.I've had 1 to 3 treatments for my multiple myeloma, counting a stem cell transplant as one.I haven't had severe esophagitis, stubborn ulcers, serious bowel disease, or major blood clots in the last 3 months.I previously responded well to carfilzomib, stopped it for reasons other than side effects, didn't relapse within 2 months after stopping, and it's been 6 months since my last dose.My condition is smouldering multiple myeloma.I have heart problems or significant heart disease.I have been diagnosed with plasma cell leukemia.I have been diagnosed with Waldenströms macroglobulinemia.I am fully active or can carry out light work.Any side effects from my previous treatments have mostly gone away.I have been diagnosed with POEMS Syndrome.I have not received a live vaccine in the last 4 weeks.I have been diagnosed with amyloidosis.My multiple myeloma did not respond to initial treatment.I have been diagnosed with multiple myeloma.I have had 3 or more treatments for my multiple myeloma and none worked well.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2B Dose Randomization
- Group 2: Part 1 Dose Escalation
- Group 3: Part 2A Dose Escalation
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned dose escalation for use in treatments?
"As this is a phase 1 trial, which only has limited evidence for safety and efficacy of Dose Escalation, we rate its safety as 1 on the scale."
Answered by AI
Is this research endeavor currently accepting new participants?
"Per the information displayed on clinicaltrials.gov, this experiment is actively seeking participants; it was initially posted on December 14th 2022 and updated most recently on December 21st 2022."
Answered by AI
How many individuals have been invited to participate in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this trial is actively looking for participants, with the first post dated December 14th 2022 and the most recent update on December 21st 2022. As of now, only 14 patients are necessary from 1 healthcare facility."
Answered by AI
Who else is applying?
What site did they apply to?
Beverly Hills Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Beverly Hills Cancer Center: < 24 hours
Average response time
- < 1 Day
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