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Proteasome Inhibitor
Teclistamab + Daratumumab for Multiple Myeloma (MajesTEC-3 Trial)
Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level >=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
MajesTEC-3 Trial Summary
This trial will compare the effectiveness of two different combinations of drugs for treating myeloma.
Who is the study for?
This trial is for people with relapsed or refractory multiple myeloma who have tried 1-3 previous treatments including a proteasome inhibitor and lenalidomide. They should be relatively active (ECOG score of 0, 1, or 2), not allergic to the drugs used in the study, haven't had live vaccines recently, and haven't been treated with BCMA-directed therapy.Check my eligibility
What is being tested?
The study tests Teclistamab combined with Daratumumab (Tec-Dara) against two other combinations: Daratumumab with Pomalidomide and Dexamethasone (DPd), or Daratumumab with Bortezomib and Dexamethasone (DVd). It aims to see which treatment works better for multiple myeloma that's come back or hasn't responded to past therapies.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, blood disorders like anemia or low platelets, infections due to weakened immune system, nerve damage symptoms such as numbness or tingling, fatigue, nausea, diarrhea, fever and shortness of breath.
MajesTEC-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma and it can be measured by tests.
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I can care for myself and am up and about more than 50% of my waking hours.
Select...
My cancer has worsened after my last treatment, as confirmed by my doctor.
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I have been diagnosed with multiple myeloma with measurable disease.
Select...
I've had 1-3 treatments for myeloma including specific drugs.
MajesTEC-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
+17 moreMajesTEC-3 Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: DPd or DVdExperimental Treatment4 Interventions
Participants will be randomized either to daratumumab, pomalidomide, dexamethasone (DPd) treatment to receive daratumumab SC injection; pomalidomide orally; dexamethasone orally or intravenously, or to Daratumumab, Bortezomib, Dexamethasone (DVd) treatment to receive daratumumab SC injection; bortezomib SC injection, and dexamethasone orally or intravenously.
Group II: Arm A: Teclistamab-daratumumab (Tec-Dara)Experimental Treatment2 Interventions
Participants will receive teclistamab and daratumumab by subcutaneous (SC) injection. Step-up doses of teclistamab will be given prior to the first full dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Bortezomib
2005
Completed Phase 2
~1140
Daratumumab
2014
Completed Phase 3
~1860
Pomalidomide
2011
Completed Phase 2
~1020
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,721 Total Patients Enrolled
70 Trials studying Multiple Myeloma
18,830 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,318 Total Patients Enrolled
49 Trials studying Multiple Myeloma
13,797 Patients Enrolled for Multiple Myeloma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received treatment targeting BCMA before.I have not had a live vaccine in the last 4 weeks.I have taken a lot of steroids, like prednisone, recently.I have been diagnosed with multiple myeloma and it can be measured by tests.I am not eligible for the daratumumab, pomalidomide, and dexamethasone combination therapy.I do not have plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light chain amyloidosis.I can care for myself and am up and about more than 50% of my waking hours.My cancer has worsened after my last treatment, as confirmed by my doctor.I've had 1-3 treatments for myeloma, including specific drugs, and didn't respond well to one.I have been diagnosed with multiple myeloma with measurable disease.Your lab test results need to be in a certain range.My condition did not improve after treatment with a CD38 antibody.I am not eligible for the daratumumab, bortezomib, and dexamethasone therapy.I've had 1-3 treatments for myeloma including specific drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Teclistamab-daratumumab (Tec-Dara)
- Group 2: Arm B: DPd or DVd
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 other theories abound about Teclistamab's potential medical applications?
"Teclistamab was first trialled in 2002 and, since then, has undergone 1433 completed clinical trials. Out of these, 693 are actively recruiting patients. A majority of these trials are based in Boston, Massachusetts."
Answered by AI
What medical conditions does Teclistamab typically address?
"Teclistamab is most often used to treat ophthalmia, sympathetic. It can also be taken to treat a variety of other conditions like branch retinal vein occlusion, macular edema, communicable diseases."
Answered by AI
Are there long-term repercussions to using Teclistamab?
"Teclistamab is estimated to be a safe medication because it is in Phase 3 of clinical trials. This means that there is some data to support its efficacy and multiple rounds of data to support its safety."
Answered by AI
Where are the different sites that are running this trial?
"There are 31 total sites for this particular study, with three being Tufts Medical Center in Boston, Massachusetts, Henry Ford Health Systems in Detroit, Michigan, and Emory University - Winship Cancer Institute in Atlanta, Georgia."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
British Columbia
California
How old are they?
18 - 65
What site did they apply to?
Medical College Of Wisconsin
Stanford University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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