650 Participants Needed

Teclistamab vs. PVd/Kd for Multiple Myeloma

(MajesTEC-9 Trial)

Recruiting at 262 trial locations
SC
SP
Overseen BySparkCures Patient Support (US only)
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Janssen Research & Development, LLC
Must be taking: Anti-CD38 antibodies, Lenalidomide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial is testing teclistamab, an antibody that helps the immune system find and destroy cancer cells, in patients with multiple myeloma who have not responded to previous treatments. It works by connecting immune cells with cancer cells to help destroy them. Teclistamab has shown promising results in early trials.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you've recently taken certain medications like strong CYP3A4 inducers or have received a live vaccine within 4 weeks before randomization.

What data supports the effectiveness of the drug Carfilzomib for treating multiple myeloma?

Carfilzomib is a new type of drug called a proteasome inhibitor, which has been reviewed for its use in patients with multiple myeloma that has come back or not responded to other treatments. This suggests it may be effective in managing this condition.12345

What safety information is available for the treatments in the Teclistamab vs. PVd/Kd trial for Multiple Myeloma?

The treatments in the trial, including bortezomib, carfilzomib, pomalidomide, and dexamethasone, have been studied for safety in multiple myeloma patients. Common side effects include anemia (low red blood cell count), neutropenia (low white blood cell count), and thrombocytopenia (low platelet count), with some patients experiencing infections due to weakened immune systems. Serious side effects like pneumonia and pulmonary embolism have been reported, but the treatments are generally considered well-tolerated.678910

What makes the drug Teclistamab unique for treating multiple myeloma?

Teclistamab is unique because it is a bispecific antibody that targets both BCMA (B-cell maturation antigen) on myeloma cells and CD3 on T-cells, helping the immune system directly attack the cancer cells, which is different from traditional chemotherapy drugs that target the cancer cells more broadly.610111213

Research Team

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for people with multiple myeloma who've had 1-3 prior treatments but didn't respond well or their disease got worse. They must meet specific criteria for measurable disease, be able to follow the study's lifestyle rules, not be pregnant or breastfeeding, and have a decent ability to perform daily activities (ECOG score of 0-2). People can't join if they've had BCMA-targeted therapy before, certain allergies or conditions like CNS involvement in their cancer, recent live vaccines, or other specific blood disorders.

Inclusion Criteria

My last cancer treatment did not work as expected.
I have been diagnosed with multiple myeloma according to international standards.
I have had 1-3 treatments for myeloma, including specific ones.
See 4 more

Exclusion Criteria

I have received treatment targeting BCMA before.
I meet the specific requirements for control therapies, including no major allergies or neuropathy.
I have a specific blood disorder like Waldenstrom's or POEMS syndrome.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive either teclistamab monotherapy or PVd/Kd based on the principal investigator's choice

Up to 9 years

Treatment Part 2

Participants receive an alternative dosing regimen of teclistamab

Up to 9 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 9 years

Treatment Details

Interventions

  • Bortezomib
  • Carfilzomib
  • Dexamethasone
  • Pomalidomide
  • Teclistamab
Trial OverviewThe study aims to see how effective Teclistamab alone is compared to two other treatment combinations: Pomalidomide with Bortezomib and Dexamethasone (PVd), or Carfilzomib with Dexamethasone (Kd) in treating relapsed/refractory multiple myeloma. Participants will receive one of these therapies based on random assignment.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: TeclistamabExperimental Treatment1 Intervention
Participants will receive teclistamab monotherapy in Part 1 and an alternative dosing regimen of teclistamab in Part 2.
Group II: Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)Experimental Treatment4 Interventions
Participants will receive either PVd or Kd based on principal investigator's choice during Part 1 of the study.

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Velcade for:
  • Multiple myeloma
  • Mantle cell lymphoma
🇺🇸
Approved in United States as Velcade for:
  • Multiple myeloma
  • Mantle cell lymphoma
🇨🇦
Approved in Canada as Velcade for:
  • Multiple myeloma
  • Mantle cell lymphoma
🇯🇵
Approved in Japan as Velcade for:
  • Multiple myeloma
  • Mantle cell lymphoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Giacomo Salvadore profile image

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar profile image

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

Cefepime combined with zidebactam (FEP-ZID) demonstrated a broad and potent in vitro activity against multidrug-resistant (MDR) bacteria, including challenging strains of Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii.
FEP-ZID was effective against various carbapenemase-producing bacteria and P. aeruginosa with multiple resistance mechanisms, suggesting it could be a promising treatment option for severe infections caused by these resistant pathogens.
Activity of Cefepime-Zidebactam against Multidrug-Resistant (MDR) Gram-Negative Pathogens.Thomson, KS., AbdelGhani, S., Snyder, JW., et al.[2020]
Cefpirome, a new fourth-generation cephalosporin, demonstrated excellent antibacterial activity against a wide range of pathogens, including Enterobacteriaceae and Streptococcus pneumoniae, with low minimum inhibitory concentrations (MIC90) indicating strong efficacy.
Compared to third-generation cephalosporins, cefpirome showed superior effectiveness against certain resistant strains, such as cephalosporinase-depressed mutants of Enterobacter cloacae, highlighting its potential as a more effective treatment option in intensive care settings.
In vitro activity of cefpirome against microorganisms isolated in haematology, oncology and intensive care units in Switzerland.Liassine, N., Bille, J., Breer, C., et al.[2023]
Carfilzomib is an effective treatment for patients with relapsed or refractory multiple myeloma, as shown in the PX-171-003-A1 phase II trial, which involved patients who had already undergone at least two prior therapies.
Common side effects of carfilzomib include fatigue, anemia, nausea, and thrombocytopenia, and it is recommended to use dexamethasone as premedication to reduce the risk of infusion reactions.
Carfilzomib: A new proteasome inhibitor for relapsed or refractory multiple myeloma.Steele, JM.[2014]

References

Activity of Cefepime-Zidebactam against Multidrug-Resistant (MDR) Gram-Negative Pathogens. [2020]
In vitro activity of cefpirome against microorganisms isolated in haematology, oncology and intensive care units in Switzerland. [2023]
Carfilzomib: A new proteasome inhibitor for relapsed or refractory multiple myeloma. [2014]
Evaluating the clinical effectiveness of new beta-lactam/beta-lactamase inhibitor combination antibiotics: A systematic literature review and meta-analysis. [2023]
Mutations in ompK36 differentially impact in vitro synergy of meropenem/vaborbactam and ceftazidime/avibactam in combination with other antibiotics against KPC-producing Klebsiella pneumoniae. [2023]
Randomized phase II study of bortezomib, thalidomide, and dexamethasone with or without cyclophosphamide as induction therapy in previously untreated multiple myeloma. [2022]
Treatment-related adverse events in patients with relapsed/refractory multiple myeloma. [2017]
Carfilzomib, pomalidomide, and dexamethasone for relapsed or refractory myeloma. [2022]
Management of hematologic adverse events in patients with relapsed and/or refractory multiple myeloma treated with single-agent carfilzomib. [2017]
A randomized phase II, open-label and multicenter study of combination regimens of bortezomib at two doses by subcutaneous injection for newly diagnosed multiple myeloma patients. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
KD-PACE Salvage Therapy for Aggressive Relapsed Refractory Multiple Myeloma, Plasma Cell Leukemia and Extramedullary Myeloma. [2022]
The MUK five protocol: a phase II randomised, controlled, parallel group, multi-centre trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs. cyclophosphamide, bortezomib (Velcade) and dexamethasone (CVD) for first relapse and primary refractory multiple myeloma. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Carfilzomib Triplet Fails to Induce Superior PFS in Newly Diagnosed Multiple Myeloma. [2021]