75 Participants Needed

Teclistamab for Multiple Myeloma

Recruiting at 15 trial locations
SC
Overseen BySarah Cannon Development Innovations, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial is testing Teclistamab, a drug that helps the immune system fight a type of blood cancer in adults who haven't responded to other treatments. It works by connecting immune cells to cancer cells, making it easier for the body to attack the cancer. Teclistamab shows promise in multiple myeloma treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, certain treatments like monoclonal antibody therapy, cytotoxic therapy, and PI therapy must be stopped for a specific period before starting the trial. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug teclistamab for multiple myeloma?

Teclistamab has shown effectiveness in treating multiple myeloma, with a pivotal trial demonstrating an overall response rate of more than 60% in patients who had already tried several other treatments. It is approved by the FDA and EMA for patients with relapsed or refractory multiple myeloma, indicating its potential as a promising option for those who have not responded to other therapies.12345

Is teclistamab safe for humans?

Teclistamab has been shown to be generally safe in humans, but it can cause side effects like cytokine release syndrome (a condition where the immune system releases too many proteins into the blood too quickly), infections, and neurotoxicity (damage to the nervous system). These side effects require careful management by healthcare providers.12346

What makes the drug Teclistamab unique for treating multiple myeloma?

Teclistamab is unique because it is a bispecific antibody that engages T-cells to target and attack multiple myeloma cells by binding to CD3 on T-cells and BCMA on myeloma cells. This mechanism offers a new approach for patients who have relapsed after multiple other treatments, with a promising response rate and a potentially more tolerable side effect profile for elderly patients.12357

Research Team

RR

Robert Rifkin, MD

Principal Investigator

SCRI Development Innovations, LLC

Eligibility Criteria

Adults over 18 with Multiple Myeloma who've had at least four prior treatments, including specific therapies (PI, IMiD, CD38 antibody), can join. They must be in good health otherwise, not pregnant or planning to become so, and agree to use contraception. Participants need a body weight over 35 kg and must stay close to the trial site for monitoring after initial doses.

Inclusion Criteria

My organs are functioning well.
I have been diagnosed with multiple myeloma.
I am fully active or restricted in physically strenuous activity but can do light work.
See 12 more

Exclusion Criteria

I do not have a fever or any active infections.
I have not received any live vaccines within the last 30 days, except for the flu vaccine.
I have a bleeding disorder that gets worse when my blood cell counts are low.
See 22 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive step-up dosing of Teclistamab or Talquetamab followed by regular dosing cycles

Up to 12 months for Teclistamab or 6 months for Talquetamab

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

  • Teclistamab
  • Tocilizumab
Trial OverviewThe study is testing Teclistamab given as an outpatient treatment for Multiple Myeloma patients. It's a phase II trial which means they're looking at how effective this drug is and what side effects it has when administered outside of a hospital setting.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: TeclistamabExperimental Treatment2 Interventions
Participants will receive step up dosing of Teclistamab following the recommended dosage of TECVAYLI™ USPI followed by weekly dosing for twelve 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 2 weeks for participants who achieve partial response (PR) or better after 6 months of therapy. Participants not responding to or progressing after prior response to treatment with teclistamab can be re-screened and enrolled into the talquetamab arm.
Group II: TalquetamabExperimental Treatment2 Interventions
Participants will receive step up dosing of Talquetamab following the recommended dosage of TALVEY™ USPI followed by every 2 week dosing for six 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 6). Talquetamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better after Cycle 4. Participants in the talquetemab arm cannot be re-screened for or re-enrolled into the teclistamab arm.

Teclistamab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tecvayli for:
  • Relapsed or refractory multiple myeloma in adults who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
🇪🇺
Approved in European Union as Tecvayli for:
  • Relapsed or refractory multiple myeloma in adults who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

SCRI Development Innovations, LLC

Lead Sponsor

Trials
193
Recruited
13,800+

Johnson & Johnson

Industry Sponsor

Trials
116
Recruited
167,000+

Janssen Research & Development, LLC

Industry 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

Teclistamab-cqyv is a bispecific T-cell engager antibody that effectively activates the immune system to target multiple myeloma cells, showing an overall response rate of over 60% in heavily pretreated patients.
The side effect profile of teclistamab-cqyv is more tolerable compared to other BCMA-targeted therapies, making it a suitable treatment option for elderly patients with relapsed or refractory multiple myeloma, and it has received FDA approval for use as monotherapy.
Teclistamab-cqyv: The First Bispecific T-Cell Engager Antibody for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma.Hua, G., Scanlan, R., Straining, R., et al.[2023]
Teclistamab, a bispecific antibody targeting CD3 and BCMA, has received conditional approval in the EU and full approval in the US for treating adult patients with relapsed or refractory multiple myeloma after multiple prior therapies.
The approvals are based on its efficacy in patients who have undergone at least three to four previous treatments, including specific types of therapies, highlighting its role as a treatment option for difficult-to-treat cases of multiple myeloma.
Teclistamab: First Approval.Kang, C.[2022]
Teclistamab-cqyv is an FDA and EMA-approved bispecific antibody that effectively targets multiple myeloma (MM) by engaging T cells to attack cancer cells, showing a 60% overall response rate in heavily pretreated relapsed/refractory patients.
This treatment is specifically designed for patients who have undergone at least three prior therapies and have shown disease progression, highlighting its role in advanced stages of MM where other treatments have failed.
Teclistamab-cqyv in multiple myeloma.Martino, EA., Bruzzese, A., Labanca, C., et al.[2023]

References

Teclistamab-cqyv: The First Bispecific T-Cell Engager Antibody for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma. [2023]
Teclistamab: First Approval. [2022]
Teclistamab-cqyv in multiple myeloma. [2023]
Teclistamab in patients with multiple myeloma and impaired renal function. [2023]
Teclistamab in Relapsed or Refractory Multiple Myeloma. [2023]
Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody. [2023]
Population Pharmacokinetics and Exposure-Response with Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma: Results From MajesTEC-1. [2023]