Talquetamab + Lenalidomide for Multiple Myeloma

Recruiting at 1 trial location

Overseen By Brent LaStofka LaStofka

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Corticosteroids, Monoclonal antibodies

Disqualifiers: Active CNS involvement, Plasma cell leukemia, Active malignancies, Cardiac conditions, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 13 months

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Multiple myeloma (MM) is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage. Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you must stop taking your current medications. However, it does mention that certain treatments, like targeted therapy or monoclonal antibody therapy, should not have been received within specific time frames before starting the study. It's best to discuss your current medications with the study team to determine any necessary adjustments.

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

Research shows that Talquetamab, a new type of drug, helped nearly three-quarters of patients with difficult-to-treat multiple myeloma by activating the immune system to target cancer cells. Additionally, Lenalidomide, when used with another drug called dexamethasone, has been shown to improve patient outcomes and survival in multiple myeloma. ^{1 2 3 4 5}

What safety information is available for Talquetamab and Lenalidomide in treating multiple myeloma?

Lenalidomide, used for multiple myeloma, can cause side effects like low blood cell counts, fatigue, muscle cramps, rash, infections, trouble sleeping, and blood clots. Talquetamab has been approved for use in relapsed or refractory multiple myeloma, but specific safety details were not provided in the available research. ^{2 6 7 8 9}

How is the drug Talquetamab + Lenalidomide unique for treating multiple myeloma?

Talquetamab is a novel drug that works by targeting a specific protein (GPRC5D) on cancer cells and activating the immune system to attack these cells, making it different from other treatments. Lenalidomide, on the other hand, is known for its ability to enhance the immune response and inhibit cancer cell growth. The combination of these two drugs offers a unique approach by both directly targeting cancer cells and boosting the body's immune response. ^{1 2 3 4 7}

Research Team

Surbhi Sidana, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for individuals who have multiple myeloma and are in the recovery period after a stem cell transplant. Participants must meet certain health standards to be eligible.

Inclusion Criteria

Women must meet specific contraception requirements

My cancer has not worsened before signing up for this trial.

I am fully active or have some restrictions but can still care for myself.

Exclusion Criteria

My multiple myeloma has returned or did not respond to treatment.

I have not taken certain medications recently.

I cannot tolerate lenalidomide due to side effects.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive talquetamab for one cycle and a combination of talquetamab and lenalidomide for cycles 2-13 after autologous stem cell transplant

13 months

Monthly visits

Follow-up

Participants are monitored for safety, progression-free survival, overall survival, and quality of life

4 years

Treatment Details

Interventions

• Lenalidomide
• Talquetamab

Trial Overview The study tests Talquetamab with Lenalidomide versus Talquetamab alone as maintenance therapy post-stem cell transplant in treating multiple myeloma.

Participant Groups

Group I: Talquetamab Experimental Treatment 2 Interventions

Study participants will receive talquetamab (JNJ-64407564) for one cycle and a combination of talquetamab and lenalidomide for cycles 2-13 after autologous stem cell transplant (ASCT).

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Janssen, LP

Industry Sponsor

Trials

169

Recruited

329,000+

Founded

1953

Headquarters

Beerse, Belgium

Known For

Mental Health Therapies

Top Products

Imodium, Remicade, Invega, Procrit

Joaquin Duato

Janssen, LP

Chief Executive Officer since 2022

MBA from ESADE Business School

Biljana Naumovic

Janssen, LP

Chief Medical Officer since 2023

MD from Belgrade University Medical School

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2023

MD

Findings from Research

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]

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]

Lenalidomide is a powerful treatment for multiple myeloma (MM) that works by directly causing cancer cell death, preventing cancer cells from sticking to bone marrow, and enhancing the body's immune response against tumors.

In combination with dexamethasone, lenalidomide has shown superior effectiveness in clinical trials, leading to improved patient outcomes such as longer survival and FDA approval for treating relapsed MM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of lenalidomide in combination with dexamethasone for the treatment of multiple myeloma. Hideshima, T., Raje, N., Richardson, PG., et al.[2021]

Lenalidomide (Revlimid) has been rapidly developed and recently approved for treating relapsed multiple myeloma, showing durable clinical responses, especially when combined with dexamethasone.

Clinical trials indicate that lenalidomide is generally well tolerated by patients, with manageable side effects, making it a promising option for those with relapsed and refractory multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide in multiple myeloma. Richardson, PG., Mitsiades, C., Hideshima, T., et al.[2018]

In a pooled analysis of two large phase III trials involving 704 patients with relapsed/refractory multiple myeloma, treatment with lenalidomide plus dexamethasone resulted in a significantly higher overall response rate (60.6% vs 21.9%) and improved complete response rate (15.0% vs 2.0%) compared to dexamethasone plus placebo.

Patients receiving lenalidomide plus dexamethasone also experienced longer survival, with a median overall survival of 38.0 months compared to 31.6 months for those on dexamethasone-placebo, indicating a substantial benefit from this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up on overall survival from the MM-009 and MM-010 phase III trials of lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma. Dimopoulos, MA., Chen, C., Spencer, A., et al.[2022]

Lenalidomide combined with dexamethasone has been shown to be effective for treating relapsed/refractory multiple myeloma, and it has received approval from both the FDA and EMA for patients who have undergone at least one prior therapy.

The most common serious side effects include cytopenias and infections, but an expert panel has provided management strategies to minimize these risks, ensuring that patients can receive the full benefits of the treatment without unnecessary dose reductions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma. Palumbo, A., Dimopoulos, M., San Miguel, J., et al.[2018]

Lenalidomide, when combined with dexamethasone, significantly improves response rates and survival in patients with relapsed/refractory multiple myeloma, showing a response rate of 60% compared to 20% with placebo in Phase III trials.

While lenalidomide is effective, it is associated with common adverse events such as hematologic toxicity and venous thromboembolism, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current treatment strategies with lenalidomide in multiple myeloma and future perspectives. Larocca, A., Cavallo, F., Mina, R., et al.[2018]

Lenalidomide, when combined with dexamethasone, is a safe and effective treatment for newly diagnosed multiple myeloma patients who cannot undergo autologous stem cell transplantation, providing rapid disease control.

Long-term use of lenalidomide has led to significant improvements in progression-free survival for patients ineligible for stem cell transplantation and has resulted in deep, durable remissions for those with relapsed or refractory multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on the use of lenalidomide for the treatment of multiple myeloma. Zagouri, F., Terpos, E., Kastritis, E., et al.[2018]

Novel therapies for multiple myeloma, such as thalidomide, lenalidomide, and bortezomib, have significantly improved patient outcomes but come with specific and manageable toxicity profiles.

Common adverse events include somnolence, venous thromboembolism, myelosuppression, gastrointestinal disturbances, and peripheral neuropathy, which can be effectively managed through patient monitoring and supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of treatment-related adverse events in patients with multiple myeloma. Mateos, MV.[2018]

References

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

MonumenTAL Results for Talquetamab in Myeloma. [2023]

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

Talquetamab: First Approval. [2023]

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

A review of lenalidomide in combination with dexamethasone for the treatment of multiple myeloma. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Lenalidomide in multiple myeloma. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Long-term follow-up on overall survival from the MM-009 and MM-010 phase III trials of lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Lenalidomide in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Current treatment strategies with lenalidomide in multiple myeloma and future perspectives. [2018]

8. England pubmed.ncbi.nlm.nih.gov

An update on the use of lenalidomide for the treatment of multiple myeloma. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Management of treatment-related adverse events in patients with multiple myeloma. [2018]