Limited-duration Teclistamab for Multiple Myeloma

Recruiting at 4 trial locations

Overseen By Leonard Fiannaca, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Abramson Cancer Center at Penn Medicine

Must be taking: Teclistamab

Disqualifiers: Systemic amyloidosis, POEMS syndrome, 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: 1

Duration: 6-9 months

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating multiple myeloma, a type of blood cancer, using a medication called teclistamab. Typically, patients take this drug indefinitely, but this trial examines whether stopping it after achieving a strong response is as effective as continuing it long-term. Researchers aim to determine if this approach reduces side effects, such as infections, while still controlling the cancer. Eligible participants have taken teclistamab for 6-9 months, responded well, and tried other treatments previously. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

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 mainly focuses on the use of teclistamab, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that teclistamab, a treatment for multiple myeloma, has been studied for its safety in patients with this condition. Studies have found that teclistamab can lead to strong and lasting improvements in patients who have tried other treatments, indicating its effectiveness.

Regarding safety, teclistamab has some side effects, but they are generally manageable. Common side effects include fatigue, low blood cell counts, and infections, which are often mild to moderate. In some cases, more serious side effects like cytokine release syndrome, where the immune system overreacts, have occurred, but these are usually treatable.

Teclistamab is already approved for use in other treatments, suggesting some level of known safety. However, those considering joining a trial should consult their healthcare providers about potential risks to receive personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Teclistamab is unique because it offers a new way to manage multiple myeloma by acting as a bispecific antibody targeting BCMA and CD3, which helps direct the immune system to attack cancer cells. Unlike traditional treatments like chemotherapy or proteasome inhibitors that directly target cancer cells, teclistamab harnesses the body's own immune response, potentially leading to fewer side effects. Researchers are excited about this approach because it could provide an effective treatment option for patients who have become resistant to conventional therapies, offering hope for better control of the disease.

What evidence suggests that this treatment might be an effective treatment for multiple myeloma?

Research has shown that teclistamab holds promise for treating multiple myeloma, a type of blood cancer. In the MajesTec trial, 63% of patients responded well, with most experiencing a reduction in cancer size after using teclistamab. Real-world evidence also supports its effectiveness, even for those who might not qualify for other trials. This treatment targets a protein called BCMA on cancer cells, aiding the immune system in attacking the cancer. Overall, teclistamab offers hope for individuals with relapsed or hard-to-treat multiple myeloma. Participants in this trial will enter an "Off Drug Surveillance" phase, during which they will stop receiving teclistamab and be closely monitored for any growth of their multiple myeloma. If their multiple myeloma begins to grow, they will restart teclistamab. ^{1 4 6 7 8}

Who Is on the Research Team?

Alfred Garfall, MD

Principal Investigator

Penn Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with multiple myeloma who've had at least three prior treatments, including a proteasome inhibitor, thalidomide analog, and anti-CD38 antibody. They should have responded well to teclistamab therapy (achieving ≥VGPR) without disease progression when enrolling. Patients must not have systemic amyloidosis or POEMS syndrome and should be in good physical condition.

Inclusion Criteria

I do not have systemic amyloidosis or POEMS syndrome.

I have had 3 or more treatments for my condition.

I received a teclistamab dose within the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive teclistamab for 6 to 9 months until achieving a very good partial response (VGPR) or better

6-9 months

Regular visits every 1-4 weeks

Off Drug Surveillance

Participants stop receiving teclistamab and are monitored for disease progression

6 months

Frequent monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment discontinuation

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Off Drug Surveillance

Trial Overview The study tests if patients can safely stop taking teclistamab after a very good response instead of continuing indefinitely. Participants will be monitored closely for signs of the cancer returning. The goal is to see if this approach is as effective as continuous treatment while potentially reducing side effects and resistance.

How Is the Trial Designed?

Group I: Off Drug Surveillance Experimental Treatment 1 Intervention

Participants will stop receiving teclistamab and will be monitored closely for growth of their multiple myeloma. Participants will restart teclistamab if their multiple myeloma starts to grow.

Off Drug Surveillance is already approved in European Union, United States for the following indications:

Approved in European Union as Tecvayli for:

• Relapsed or refractory multiple myeloma

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

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

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, 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, a bispecific antibody targeting B-cell maturation antigen and CD3, has shown promising efficacy in treating relapsed/refractory multiple myeloma, with the recommended Phase II dose established at 1.5 mg/kg subcutaneously, which maintains drug levels above the effective concentration needed for maximum cytotoxicity.

The study utilized pharmacokinetic modeling to predict effective dosing ranges, confirming that doses of 0.27 mg/kg and 0.72 mg/kg intravenously, as well as 0.72 mg/kg subcutaneously, achieved serum concentrations that correlate with effective treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma. Girgis, S., Lin, SXW., Pillarisetti, K., et al.[2022]

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 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]

Citations

1. 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% ...

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

Outcomes of teclistamab in patients with relapsed/ ... The median overall PFS for all patients with BCMA-DT was 4.8 months, closely aligning with our findings, and the 9-month OS rate was 60% [27].

3. 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 ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12061972/

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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12290224/

Safety outcomes of teclistamab accelerated dose escalation Accelerated dose escalation strategy allowed for the optimization of hospitalization and resources. Keywords: Multiple myeloma, teclistamab ...

7. 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.

8. 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.