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

Trial Summary

What is the purpose of this trial?

The researchers are doing this study to find out whether talquetamab is an effective treatment after BCMA CAR Tcell therapy for people with relapsed or refractory multiple myeloma. All participants in this study will have already received the BCMA CAR T-cell therapy ide-cel for their disease.

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.

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

In the MonumenTAL-1 trial, nearly 75% of patients with relapsed or refractory multiple myeloma experienced significant anticancer effects from Talquetamab, a drug that targets specific proteins on cancer cells and activates the immune system to fight the cancer. ^{1 2 3 4 5}

Is Talquetamab safe for humans?

Talquetamab has been tested in early clinical trials for multiple myeloma, showing it is generally well-tolerated with some side effects like skin, mouth, and nail issues. It has fewer infections compared to similar treatments, indicating a favorable safety profile. ^{1 2 3 4 5}

How is the drug talquetamab different from other treatments for multiple myeloma?

Talquetamab is unique because it is a first-in-class bispecific antibody that targets a specific protein (GPRC5D) found on cancerous plasma cells and recruits T cells to attack them. This approach is different from other treatments that target more common proteins like CD38, and it has shown significant anticancer effects in patients with relapsed or refractory multiple myeloma. ^{1 2 3 5 6}

Research Team

Sham Mailankody, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

My liver tests are within the required limits.

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

Exclusion Criteria

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

I have a significant brain or nerve condition.

You have tested positive for certain infectious diseases.

Timeline

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

Treatment Details

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.

Participant Groups

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 Business School

John (Jack) Lawrence

Janssen Pharmaceuticals

Chief Medical Officer since 2023

MD from University of Virginia School of Medicine

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Talquetamab: First Approval. [2023]

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

MonumenTAL Results for Talquetamab in Myeloma. [2023]

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

Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myeloma. [2023]

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

An Embarrassment of Riches: Three FDA-Approved Bispecific Antibodies for Relapsed Refractory Multiple Myeloma. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

Talquetamab in multiple myeloma. [2023]

6. Japan pubmed.ncbi.nlm.nih.gov

[Therapeutic monoclonal antibodies against multiple myeloma]. [2019]