Talquetamab for Multiple Myeloma

Recruiting at 6 trial locations

Overseen By Saad Usmani, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Anticoagulants, Corticosteroids, Monoclonal antibodies, others

Disqualifiers: CNS pathology, Autoimmune disease, Hepatitis, 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: up to 2 years

17 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether talquetamab (also known as Talvey) can effectively treat multiple myeloma, a type of blood cancer, after patients have tried a specific CAR T-cell therapy called ide-cel. The trial focuses on individuals whose disease has returned or not responded well to other treatments, such as certain drugs and antibodies. Ideal candidates have undergone multiple myeloma treatments, recently received ide-cel therapy, and show no current disease progression. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

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

The trial protocol does not specify if you need to stop your current medications. However, it does mention that certain treatments, like monoclonal antibody therapy and cytotoxic therapy, should not have been received within a specific time frame before enrollment. It's best to discuss your current medications with the trial team to get a clear answer.

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

In a previous study, 78.8% of patients taking talquetamab experienced mild to moderate side effects, such as tiredness and nausea. Most participants tolerated it well. The FDA has approved talquetamab for treating multiple myeloma in patients who have tried several other treatments. This approval indicates a well-understood safety profile for these patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Talquetamab is unique because it introduces a new approach to treating multiple myeloma by targeting a protein called GPRC5D, which is found on myeloma cells but not on most healthy cells. This specificity could potentially lead to fewer side effects compared to traditional treatments like chemotherapy, which attacks both cancerous and healthy cells. Additionally, Talquetamab is administered subcutaneously, meaning it's given as an injection under the skin, which might be more convenient and comfortable for patients compared to intravenous infusions. Researchers are excited about Talquetamab because it represents a novel mechanism of action in the fight against multiple myeloma, offering hope for improved outcomes with potentially less toxicity.

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

Research shows that talquetamab, which participants in this trial will receive, has promising results for treating relapsed or refractory multiple myeloma, a type of blood cancer. Studies have found that 73% of patients experienced a response to this treatment. In another study, more than half of the participants maintained their positive response for at least 9 months. Patients also reported feeling better and having an improved quality of life. These findings suggest that talquetamab could be a good option for those who have already tried other treatments, such as BCMA CAR T-cell therapy. ^{5 6 7 8 9}

Who Is on the Research Team?

Sham Mailankody, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with multiple myeloma who've had BCMA CAR T-cell therapy. They must be in good health, not planning to have children soon, and able to follow the study plan. People can't join if they've had certain other treatments recently, are pregnant or breastfeeding, have serious infections or illnesses that could affect participation, or require high doses of steroids.

Inclusion Criteria

Your blood and urine tests show very low levels of certain proteins.

Must sign an ICF (or their legally acceptable representative must sign) indicating understanding and willingness to participate in the study

My liver tests are within the required limits.

Exclusion Criteria

You have certain medical conditions or diseases at the same time.

Serious medical of psychiatric illness likely to interfere with participation

I have a significant brain or nerve condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous Talquetamab after BCMA CAR T-cell therapy

up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Talquetamab

Trial Overview

The study tests Talquetamab's effectiveness in patients with relapsed/refractory multiple myeloma post-BCMA CAR T-cell therapy ide-cel. It aims to determine if this drug can help after previous treatment with a specific cell therapy.

How Is the Trial Designed?

Group I: Talquetamab Experimental Treatment 1 Intervention

Subcutaneous Talquetamab

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Janssen Pharmaceuticals

Industry Sponsor

Trials

87

Recruited

208,000+

Joaquin Duato

Janssen Pharmaceuticals

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Pharmaceuticals

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Talquetamab, a bispecific T-cell engager targeting GPRC5D and CD3, has received accelerated approval in the USA and conditional marketing authorization in the EU for treating adults with relapsed or refractory multiple myeloma, highlighting its potential as a new treatment option.

This approval marks a significant milestone in the development of talquetamab, indicating its efficacy and safety in addressing a challenging form of cancer that has not responded to previous treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Talquetamab: First Approval. Keam, SJ.[2023]

Three new bispecific antibodies—teclistamab, elranatamab, and talquetamab—have received accelerated FDA approval for treating relapsed/refractory multiple myeloma, indicating their potential efficacy in this challenging condition.

While these agents show promise, the medical community is currently awaiting results from randomized phase III clinical trials to better understand their effectiveness compared to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Embarrassment of Riches: Three FDA-Approved Bispecific Antibodies for Relapsed Refractory Multiple Myeloma. Firestone, R., Lesokhin, AM., Usmani, SZ.[2023]

In the MonumenTAL-1 trial, nearly 75% of the 288 patients with relapsed/refractory multiple myeloma showed significant anticancer effects from the investigational drug talquetamab.

Talquetamab is a first-in-class bispecific antibody that targets GPRC5D on malignant plasma cells while sparing normal cells, effectively activating T cells to mount an immune response against the cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MonumenTAL Results for Talquetamab in Myeloma. [2023]

Monoclonal antibodies (MoAbs) like elotuzumab and daratumumab, which target specific antigens (CS1 and CD38) found in over 90% of multiple myeloma patients, show promising anti-myeloma effects, especially when combined with lenalidomide.

The article reviews various emerging MoAbs for multiple myeloma, highlighting their potential in improving treatment outcomes, although multiple myeloma remains largely incurable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic monoclonal antibodies against multiple myeloma]. Kuroda, J.[2019]

Talquetamab, a bispecific antibody targeting GPRC5D and CD3, shows similar efficacy and durability of response in treating relapsed or refractory multiple myeloma compared to teclistamab, the first bispecific antibody approved for this condition.

While talquetamab has a lower incidence of infections than teclistamab, it presents unique side effects related to skin, oral, and nails, yet remains a well-tolerated and effective treatment option for patients with heavily pretreated multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Talquetamab in multiple myeloma. Liu, L., Krishnan, A.[2023]

In the phase 1 MonumenTAL-1 study involving patients with refractory or relapsed multiple myeloma, two doses of talquetamab (405 μg/kg weekly and 800 μg/kg every other week) were found to be well tolerated, with most side effects being mild or moderate, including cytokine release syndrome (CRS).

The treatment showed promising efficacy, with most participants experiencing a reduction in cancer signs and a median duration of response of 8-10 months, indicating talquetamab's potential as a new option for patients who have not responded to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myeloma. Chari, A., Askari, E., Caers, J., et al.[2023]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40631904/

Talquetamab improves patient-reported symptoms and ...

Talquetamab improves patient-reported symptoms and health-related quality of life in relapsed or refractory multiple myeloma: Results from the ...

2.

ashpublications.org

ashpublications.org/blood/article/144/Supplement%201/7047/527044/Real-World-Outcomes-with-Talquetamab-a-T-Cell

Real World Outcomes with Talquetamab, a T-Cell-Redirecting ...

In summary, we found that talquetamab exhibited a comparable efficacy and safety profile in the real-world setting as in the pivotal trial.

3.

talvey.com

talvey.com/results-with-talvey/

Results with TALVEY® | TALVEY® (talquetamab-tgvs)

Significant response rates in a clinical trial · An estimated 85% of people maintained their response for at least 9 months · More than half of the participants ...

4.

ahdbonline.com

ahdbonline.com/articles/ongoing-analyses-and-recent-data-for-talvey-in-multiple-myeloma

Ongoing Analyses and Recent Data for Talvey in Multiple ...

MonumenTAL-1 (NCT03399799/NCT04634552) was a phase 1/2 study that had shown a 73% overall response rate (ORR) in 100 patients receiving a 0.4-mg ...

5.

cancernetwork.com

cancernetwork.com/view/talquetamab-elicits-durable-responses-survival-in-r-r-multiple-myeloma

Talquetamab Elicits Durable Responses, Survival in R/R ...

In the weekly, biweekly, and TCR talquetamab groups, respectively, the median progression-free survival was 7.5 months, 11.2 months, and 7.7 ...

6.

talveyhcp.com

talveyhcp.com/

TALVEY® (talquetamab-tgvs) | Official HCP Website

US FDA approves TALVEY (talquetamab-tgvs), a first-in-class bispecific therapy for the treatment of patients with heavily pretreated multiple myeloma.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11798766/

Talquetamab in Multiple Myeloma: Efficacy, Safety, and Future ...

Safety data revealed that 78.8% of patients experienced G1 and G2 ... As per pivotal trial data, talquetamab represents a significant advancement ...

8.

thelancet.com

thelancet.com/journals/lanhae/article/PIIS2352-3026(24)00385-5/fulltext

Safety and activity of talquetamab in patients with relapsed ...

Talquetamab continued to demonstrate high overall response rates in heavily pretreated patients with relapsed or refractory multiple myeloma ...

9.

myeloma.org

myeloma.org/treatment/multiple-myeloma-medications/talvey-talquetamab

TALVEY (talquetamab) | Int'l Myeloma Foundation

Talvey is FDA-approved for patients with relapsed or refractory myeloma who have received at least 4 prior lines of therapy.