Talquetamab + Lenalidomide for Multiple Myeloma

Recruiting at 1 trial location

Overseen By Brent 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a potential new treatment for people with multiple myeloma, a cancer affecting certain blood cells and causing organ damage. It tests the effectiveness of combining two drugs, talquetamab (Talvey) and lenalidomide (Revlimid), especially after a stem cell transplant. The study seeks participants diagnosed with symptomatic multiple myeloma who have already had or are planning a stem cell transplant. Those with this cancer diagnosis and treatment plan may be a good fit for the trial. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering a chance to contribute to important advancements in multiple myeloma treatment.

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.

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

Research has shown that talquetamab is generally safe for people with multiple myeloma, with a low risk of serious infections. The FDA approved talquetamab for patients who have tried several other treatments, confirming its safety.

Lenalidomide, another drug in this trial, has been used for multiple myeloma for some time. In studies, some patients reported a reduced appetite, but severe weight loss was uncommon. Combining lenalidomide with other treatments has helped patients without major safety issues.

Both drugs appear well-tolerated, and evidence supports their safe use in patients with multiple myeloma. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Talquetamab and Lenalidomide for treating multiple myeloma because it introduces a novel approach to targeting cancer cells. Most treatments for multiple myeloma rely on disrupting cancer cell growth or altering the immune response. However, Talquetamab is unique as it targets a specific protein called GPRC5D on the surface of myeloma cells, which is not the focus of current standard treatments. This targeted action aims to improve effectiveness and reduce side effects, making it a promising option for patients.

What evidence suggests that Talquetamab + Lenalidomide could be effective for multiple myeloma?

Research shows that talquetamab, which participants in this trial will receive, has promising results for treating multiple myeloma, with 73 out of 100 patients responding to the treatment. Many patients experienced a positive effect. Additionally, when combined with lenalidomide, as will occur in this trial after the first cycle, talquetamab continued to show high success rates in patients who had tried many other treatments. This combination works well because talquetamab helps certain immune cells attack the cancer, while lenalidomide boosts the immune system. Overall, evidence suggests this treatment could be effective for people with multiple myeloma. ^{6 7 8 9 10}

Who Is on the Research Team?

Surbhi Sidana, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen, LP

Chief Medical Officer since 2014

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

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

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

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

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]

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]

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]

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]

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]

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]

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]

Citations

1. 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.

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

Talquetamab in Multiple Myeloma: Efficacy, Safety, and Future ... Novel bispecific antibodies (BsAbs), including talquetamab, have shown promising efficacy in heavily pretreated patients, even those with ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5774211/

Final analysis of survival outcomes in the phase 3 FIRST ... Key Points. Rd continuous significantly extended OS compared with MPT and resulted in comparable OS to that with Rd18 in patients with multiple myeloma.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0959804924017647

Characteristics and outcomes in patients with lenalidomide ... Data represent treatment arms and subsequent therapies from 9 trials (2014–2022). Outcomes were suboptimal: 55 % response rate, 10-mo median PFS, and 28-mo ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3256976/

Safety and Efficacy of Lenalidomide in Relapsed or ... Combination lenalidomide and dexamethasone (Len+Dex) has been shown to increase response rates and prolong survival compared with dexamethasone alone.

9. myeloma.org myeloma.org/revlimid-lenalidomide

Revlimid (Lenalidomide) In the phase III FIRST clinical trial, 23% of the newly diagnosed patients experienced a decreased appetite. Of those, only 3% had weight loss or malnutrition.

10. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/4866/505745/Efficacy-and-Safety-in-Patients-with-Lenalidomide

Efficacy and Safety in Patients with Lenalidomide-Refractory ... The PFS rate of 85% at 12 mo post infusion (89% in pts with MRD-negative ≥CR) compares favorably with real-world data in similar populations (12 ...