← Back to Search

Monoclonal Antibodies

Tec-DR and Tal-DR for Multiple Myeloma (MajesTEC-7 Trial)

Phase 3
Recruiting
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
Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 9 years
Awards & highlights

MajesTEC-7 Trial Summary

This trial will compare the effectiveness of two different combinations of drugs for treating patients with multiple myeloma who have received at least one prior therapy.

Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma who can't have high-dose chemotherapy with stem cell transplant due to age or other health issues. They should be able to perform daily activities (ECOG score 0-2) and must not plan on pregnancy or fathering children during the study.Check my eligibility
What is being tested?
The study compares two treatments: Teclistamab combined with Daratumumab and Lenalidomide (Tec-DR), versus Talquetamab with the same combination (Tal-DR). The goal is to see which treatment works better compared to a standard therapy of Daratumumab, Lenalidomide, and Dexamethasone.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication ingredients, infusion-related reactions from drugs like Teclistamab or Talquetamab, and any known risks associated with Daratumumab or Lenalidomide as per their prescribing information.

MajesTEC-7 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have been diagnosed with multiple myeloma.

MajesTEC-7 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 9 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 9 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response (CR) or Better
Progression Free Survival (PFS)
Secondary outcome measures
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
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 Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
+13 more

MajesTEC-7 Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)Experimental Treatment3 Interventions
Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.
Group II: Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)Experimental Treatment3 Interventions
Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.
Group III: Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)Active Control3 Interventions
Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~1860
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
976 Previous Clinical Trials
6,382,971 Total Patients Enrolled
70 Trials studying Multiple Myeloma
17,872 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
746 Previous Clinical Trials
3,958,568 Total Patients Enrolled
49 Trials studying Multiple Myeloma
12,839 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05552222 — Phase 3
Multiple Myeloma Research Study Groups: Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR), Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR), Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT05552222 — Phase 3
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05552222 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different medical facilities is this research being conducted today?

"The University of Texas MD Anderson Cancer Center in Houston, City of Hope Orange County Lennar Foundation Cancer Center in Irvine, and Oregon Health & Science University in Portland are just some of the 25 locations running this clinical trial."

Answered by AI

How many people are involved in this clinical trial at the most?

"The clinical trial is admitting 1030 patients across 25 locations."

Answered by AI

Are volunteers needed for this experiment?

"Indeed, the listing on clinicaltrials.gov makes it clear that this study is open for recruitment. This particular trial was first made public on October 25th, 2022 and updated November 3rd, 2022. In total, they are looking for 1030 individuals across 25 different locations."

Answered by AI

What goals does this trial hope to accomplish?

"The primary outcome that sponsor Janssen Research & Development, LLC will be measuring is the rate of participants with a sustained minimal residual disease-negative complete response. Additionally, this trial will also investigate other outcomes such as laboratory parameter abnormalities, anti-drug antibodies to teclistamab, and serum concentrations of teclistamab."

Answered by AI

What is the FDA's official stance on Teclistamab, Daratumumab SC, Lenalidomide (Tec-DR)?

"There is some evidence to support the efficacy of Teclistamab, Daratumumab SC and Lenalidomide (Tec-DR) as well as data from multiple rounds that suggest it is safe. Consequently, our team has rated it a 3 on our safety scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
2022. "A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05552222.
~1060 spots leftby Apr 2031
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top