Teclistamab for Multiple Myeloma

(MajesTEC-10 Trial)

Recruiting at 53 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must be taking: Protease inhibitors

Must not be taking: Bispecific antibodies, CAR-T therapy

Disqualifiers: CNS involvement, Major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to approximately 3 years

108 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Teclistamab has shown to be effective in treating multiple myeloma, with a clinical trial demonstrating an overall response rate of more than 60% in patients who had already tried several other treatments. It works by activating the immune system to target and attack myeloma cells, and it has been approved by the FDA for use in patients with relapsed or refractory multiple myeloma. ^{1 2 3 4 5}

Is teclistamab safe for humans?

Teclistamab, used for treating multiple myeloma, has shown some 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). However, it is considered more tolerable for elderly patients compared to other similar treatments. ^{1 2 3 4 6}

How is the drug Teclistamab unique for treating multiple myeloma?

Teclistamab is unique because it is a bispecific antibody that simultaneously targets CD3 on T cells and BCMA on myeloma cells, effectively redirecting the immune system to attack the cancer. This mechanism is different from other treatments and has shown a high response rate in patients who have already tried multiple other therapies. ^{1 2 3 5 7}

What is the purpose of this trial?

The purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change).

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for adults with multiple myeloma who've had 1-3 prior treatments, including specific drugs like protease inhibitors and an anti-CD38 antibody. They should have measurable disease levels and be in fair to good physical condition. Women of childbearing age must test negative for pregnancy and agree to ongoing tests.

Inclusion Criteria

My last cancer treatment did not work, as confirmed by my doctor.

I can take care of myself and am up and about more than half of my waking hours.

I've had 1-3 prior treatments for myeloma, including specific drugs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive teclistamab monotherapy (pre-change or post-change) until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study

Up to approximately 3 years

Cycle 1 (28 days cycle): Predose to Day 7 postdose, Cycle 3 (28 days cycle): Day 1

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Teclistamab

Trial Overview The study is testing Teclistamab, a drug for multiple myeloma, made using two different manufacturing processes. It aims to compare how the body absorbs, distributes, and gets rid of the drug from both sources.

Participant Groups

Group I: Arm B: Post-change Teclistamab Experimental Treatment 1 Intervention

Participants will receive teclistamab monotherapy (made from the post-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first.

Group II: Arm A: Pre-change Teclistamab Experimental Treatment 1 Intervention

Participants will receive teclistamab monotherapy (made from the pre-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first.

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

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab-cqyv in multiple myeloma. Martino, EA., Bruzzese, A., Labanca, C., et al.[2023]

Teclistamab has demonstrated strong anti-myeloma activity in patients who have severe renal impairment, indicating its potential effectiveness in a challenging patient population.

The study highlights the importance of evaluating treatments like teclistamab for their efficacy in patients with specific health conditions, such as renal issues, which can complicate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab in patients with multiple myeloma and impaired renal function. Joiner, L., Bal, S., Godby, KN., et al.[2023]

In a phase 1-2 study involving 165 patients with relapsed or refractory multiple myeloma, teclistamab demonstrated a high overall response rate of 63%, with 39.4% achieving a complete response, indicating its efficacy as a treatment option for heavily pre-treated patients.

While teclistamab showed promising results, common adverse effects included cytokine release syndrome (72.1% of patients) and neutropenia (70.9%), though most toxicities were grade 1 or 2, suggesting a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab in Relapsed or Refractory Multiple Myeloma. Moreau, P., Garfall, AL., van de Donk, NWCJ., et al.[2023]

Teclistamab is the first bispecific antibody approved for treating relapsed or refractory multiple myeloma, showing impressive efficacy in heavily pretreated patients, making it a promising option in this challenging area of treatment.

While teclistamab offers significant benefits, it also has notable adverse effects such as cytokine release syndrome, infections, and neurotoxicity, requiring careful management and precautions by healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody. Pan, D., Richter, J.[2023]

Teclistamab, a bispecific antibody for treating relapsed/refractory multiple myeloma, showed a positive exposure-response relationship for overall response rate (ORR) at the recommended phase II dose (RP2D) of 1.5 mg/kg subcutaneously weekly, based on data from 338 patients in the MajesTEC-1 study.

While factors like body weight and myeloma type influenced teclistamab's pharmacokinetics, they did not significantly affect its efficacy, indicating that the drug's effectiveness remains consistent across different patient profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Exposure-Response with Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma: Results From MajesTEC-1. Miao, X., Wu, LS., Lin, SXW., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Teclistamab-cqyv: The First Bispecific T-Cell Engager Antibody for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Teclistamab: First Approval. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Teclistamab-cqyv in multiple myeloma. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Teclistamab in patients with multiple myeloma and impaired renal function. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Teclistamab in Relapsed or Refractory Multiple Myeloma. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody. [2023]

7. France pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Exposure-Response with Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma: Results From MajesTEC-1. [2023]