Teclistamab for Multiple Myeloma

Recruiting at 14 trial locations

Overseen By Mercedes Martillo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Multiple Myeloma Research Consortium

Disqualifiers: Plasma cell leukemia, Waldenström's, POEMS, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: Variable, depending on investigational arm

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Teclistamab, an experimental drug, to identify the best therapy for people with multiple myeloma, a type of blood cancer. Researchers will test multiple treatments to determine which works best for different patients. This study suits those who have tried certain medications for their multiple myeloma but still face challenges, such as the disease returning or not responding well to treatment. Participants should have measurable disease symptoms and be willing to follow study requirements. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get a clear answer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that teclistamab has been tested for safety in patients with multiple myeloma, a type of blood cancer. In earlier studies, about 67% of patients experienced infections as a side effect, with most infections being serious. However, teclistamab demonstrated promising results in treating the disease, suggesting its benefits might outweigh the risks for some patients.

These studies also examined patient responses to different doses of teclistamab. Administering doses two days apart made the treatment easier for patients to handle. While side effects remain a concern, adjustments have been made to improve patient care.

Prospective trial participants should weigh these risks against the potential benefits and discuss them with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Teclistamab is unique because it works by targeting BCMA, a protein commonly found on multiple myeloma cells. This mechanism is different from traditional options like proteasome inhibitors and immunomodulatory drugs. Researchers are excited about teclistamab because it acts as a bispecific antibody, engaging the immune system to directly attack cancer cells, potentially offering a more effective and targeted treatment. Unlike standard treatments, which often have broader effects, teclistamab’s precision may lead to better outcomes with fewer side effects.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research has shown that teclistamab holds promise for treating multiple myeloma, a type of blood cancer. In the MajesTEC-1 study, teclistamab reduced or eliminated cancer in 63% of patients. Additionally, patients experienced an average of 11.3 months without disease progression. The treatment proved effective even for those who had tried other therapies. In this trial, participants will join different arms, including an investigational arm with teclistamab. These results suggest that teclistamab could be a strong option for managing multiple myeloma. ^{6 7 8 9 10}

Who Is on the Research Team?

Hearn J Cho, MD, PhD

Principal Investigator

Multiple Myeloma Research Foundation

Are You a Good Fit for This Trial?

This trial is for adults with Multiple Myeloma who have detectable levels of M-protein, bone marrow involvement, and specific light chain criteria. They must have had prior treatments including a proteasome inhibitor, an immunomodulating agent, and a CD38-monoclonal antibody.

Inclusion Criteria

Effective contraceptive measures for persons of childbearing potential during sexual contact

Voluntarily agree to participate by giving written informed consent

Measurable disease as defined by specific criteria

Exclusion Criteria

Pregnant or lactating individuals

History of allergy or hypersensitivity to trial treatments or their excipients

My cancer has not spread to my brain or caused spinal cord compression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to investigational arms under a Master Protocol to evaluate novel therapies in relapsed or refractory multiple myeloma

Variable, depending on investigational arm

Follow-up

Participants are monitored for safety and effectiveness after treatment

Yearly follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Teclistamab

Trial Overview The trial is testing Teclistamab as part of an adaptive platform under a Master Protocol. This allows the addition of new investigational arms over time to determine the best therapy for patients with recurrent Multiple Myeloma.

How Is the Trial Designed?

Group I: Sub-Protocol B Experimental Treatment 1 Intervention

This arm will be an investigational arm

Group II: Sub-protocol A Active Control 2 Interventions

Serves as the reference arm for the platform

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?

Multiple Myeloma Research Consortium

Lead Sponsor

Trials

21

Recruited

1,200+

Published Research Related to This Trial

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]

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-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]

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-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, 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]

Citations

1. nature.com nature.com/articles/s41408-025-01408-4

Outcomes of relapse after teclistamab therapy in multiple ... The MajestTEC-1 trial demonstrated an overall response rate (ORR) of 63% and median progression-free survival (PFS) and OS of 11.3 and 18.3 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40352937/

Effectiveness and safety of teclistamab for relapsed or ... Teclistamab continues to be a promising and effective treatment option for RRMM patients, including those previously exposed to BCMA-targeted therapies.

3. ashpublications.org ashpublications.org/bloodadvances/article/9/19/4806/546235/The-efficacy-of-teclistamab-in-patients-with

The efficacy of teclistamab in patients with multiple myeloma ... Long-term follow-up results of the MajesTec trial have shown promising efficacy of teclistamab in RRMM with overall response rate (ORR) of 63% ...

4. tecvaylihcp.com tecvaylihcp.com/clinical-study-results/

Clinical Study Results | TECVAYLI® (teclistamab-cqyv) HCP The efficacy of TECVAYLI® was evaluated in 110 patients with relapsed or refractory multiple myeloma in the single-arm, open-label, multi-center, phase 1/2 ...

5. aacr.org aacr.org/about-the-aacr/newsroom/news-releases/real-world-data-shows-teclistamab-can-benefit-many-multiple-myeloma-patients-who-would-have-been-ineligible-for-pivotal-trial/

Real-world Data Shows Teclistamab Can Benefit Many ... Real-world Data Shows Teclistamab Can Benefit Many Multiple Myeloma Patients Who Would Have Been Ineligible for Pivotal Trial. July 9, 2025 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39090994

Safety outcomes of teclistamab accelerated dose escalation This article examines safety event rates following the implementation of a 2-day separation between step-up doses at one institution to streamline patient care.

7. nature.com nature.com/articles/s41408-025-01314-9

Outcomes of teclistamab in patients with relapsed/ ... Data describing outcomes of teclistamab in multiple myeloma patients with prior exposure to BCMA-directed therapy (BCMA-DT) are limited.

8. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/2398/532408/Dosing-Patterns-and-Early-Safety-and-Effectiveness

Dosing Patterns and Early Safety and Effectiveness Outcomes ... Dosing patterns and early safety and effectiveness outcomes in patients with multiple myeloma treated with Teclistamab in the community setting.

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa2203478

Teclistamab in Relapsed or Refractory Multiple Myeloma Teclistamab resulted in a high rate of deep and durable response in patients with triple-class–exposed relapsed or refractory multiple myeloma.

10. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e19504

Real-world outcomes of teclistamab for the treatment ... The incidence of infection was 67%; the majority were grade ≥ 3. The overall response rate (ORR) by IMWG criteria was 50%. All patients who ...