JNJ-87562761 for Multiple Myeloma

Recruiting at 18 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must be taking: Proteasome inhibitors, Immunomodulatory agents

Must not be taking: Corticosteroids, Monoclonal antibodies

Disqualifiers: Plasma cell leukemia, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JNJ-87562761 for individuals with multiple myeloma, a type of blood cancer, whose disease has either returned after treatment or hasn't responded to previous treatments. The trial aims to determine the best dose of this new treatment and assess its safety and tolerability for patients. It suits those who have undergone prior therapies, including certain cancer treatments, and are dealing with multiple myeloma that affects their daily life. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had certain antitumor therapies within specific time frames before starting the study treatment, such as targeted therapy, monoclonal antibody treatment, or conventional chemotherapy within 21 days, and others as listed in the exclusion criteria.

Is there any evidence suggesting that JNJ-87562761 is likely to be safe for humans?

Research has not yet provided specific safety information for JNJ-87562761 in treating multiple myeloma. This means detailed data on patient tolerance and potential side effects is not yet available.

As this study is in its early stage, the main goal is to determine a safe dose for patients. Early-stage studies typically involve smaller groups and focus on safety. Although risks may exist, the trial is designed to closely monitor participants and adjust doses to find the most effective treatment with the fewest side effects.

Early-stage trials are crucial for understanding a treatment's safety. Participants receive careful monitoring to ensure their well-being. ^{1 2 3 4 5}

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

Researchers are excited about JNJ-87562761 for multiple myeloma because it introduces a novel approach compared to existing treatments like proteasome inhibitors or immunomodulatory drugs. Unlike these standard therapies, JNJ-87562761 works by targeting specific pathways involved in the growth and survival of multiple myeloma cells, potentially offering a more precise attack on the cancer. This could lead to improved outcomes by minimizing damage to healthy cells and reducing side effects, making it a promising option for patients who have not responded well to current treatments.

What evidence suggests that JNJ-87562761 might be an effective treatment for multiple myeloma?

The treatment JNJ-87562761, administered to participants in this trial, targets the proteins JAK1 and JAK2, often found at high levels in multiple myeloma, a type of blood cancer. In a group of patients with this condition, 57% had high levels of JAK2, and 27% had high levels of JAK1. This treatment aims to cut off the cancer's "fuel" and slow its progression. Initial findings suggest this approach could be promising for those with relapsed or hard-to-treat multiple myeloma. ^{2 4 6 7 8}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for adults with multiple myeloma that has returned or hasn't improved after treatment. Participants must be in good physical condition (ECOG 0-1), have had specific prior therapies, measurable disease levels, and adequate kidney function. They cannot be pregnant or breastfeeding and must agree to contraception.

Inclusion Criteria

My multiple myeloma has returned or hasn't responded to treatment, and tests show it's measurable.

I am not pregnant or breastfeeding and won't donate or freeze my eggs/sperm. I will use condoms.

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive JNJ-87562761 with dose escalation to determine the recommended phase 2 dose (RP2D)

up to approximately 3 years

Dose Expansion

Participants receive JNJ-87562761 at the RP2D regimen(s) determined in Part 1

up to approximately 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to approximately 3 years

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-87562761

Trial Overview The study aims to find the optimal dose of JNJ-87562761 for phase 2 trials in part one and assess its safety at this dose in part two among patients with relapsed or refractory multiple myeloma.

How Is the Trial Designed?

Group I: JNJ-87562761 Experimental Treatment 1 Intervention

Participants will receive JNJ-87562761 during the Part 1 (Dose escalation) to determine the recommended phase 2 dose (RP2D) regimen(s). The dose will be escalated sequentially until the RP2D regimen(s) have been identified. In Part 2 (Dose expansion) participants will receive JNJ-87562761 at the RP2D regimen(s) determined in Part 1.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

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

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

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

Published Research Related to This Trial

In a study of multiple myeloma (MM) patients, 57% showed overexpression of JAK2 and 27% showed overexpression of JAK1, suggesting that targeting these JAK proteins could be a promising therapeutic strategy.

Treatment with the JAK inhibitor ruxolitinib, combined with bortezomib and lenalidomide, resulted in 72% cell death in MM cell lines, indicating that inhibiting the JAK/STAT pathway may effectively induce apoptosis in MM cells and could serve as a new target for therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-myeloma effects of ruxolitinib combined with bortezomib and lenalidomide: A rationale for JAK/STAT pathway inhibition in myeloma patients. de Oliveira, MB., Fook-Alves, VL., Eugenio, AIP., et al.[2021]

The pan-HDAC inhibitor JNJ-26481585 effectively induces cell death in human multiple myeloma (MM) cells at low nanomolar concentrations, demonstrating its potential as a powerful anti-cancer agent.

In combination with other anti-myeloma treatments, JNJ-26481585 shows additive effects, suggesting it could enhance the efficacy of existing therapies for treating multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical anti-myeloma activity of the novel HDAC-inhibitor JNJ-26481585. Stühmer, T., Arts, J., Chatterjee, M., et al.[2017]

Ruxolitinib, when combined with lenalidomide and methylprednisolone, shows potential to overcome resistance to lenalidomide in patients with relapsed/refractory multiple myeloma, achieving a clinical benefit rate of 49% and an overall response rate of 36% in a Phase I trial with 49 participants.

The trial demonstrated that ruxolitinib was safe, with no dose-limiting toxicities reported, although some patients experienced grade 3 or 4 adverse events, including anemia and decreased lymphocyte count, indicating a manageable safety profile for this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 study of ruxolitinib, steroids and lenalidomide for relapsed/refractory multiple myeloma patients. Berenson, JR., Kim, C., Bujarski, S., et al.[2022]

The treatment landscape for multiple myeloma (MM) has significantly improved, with four new drugs approved in 2015 alone, leading to better patient outcomes than seen in any other cancer over the past decade.

Several new investigational agents, such as Isatuximab and marizomib, show promising efficacy in clinical trials, indicating a strong potential for future regulatory approval and further advancements in MM treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New investigational drugs with single-agent activity in multiple myeloma. Rajan, AM., Kumar, S.[2022]

The treatment of multiple myeloma has significantly improved with the introduction of more effective therapies, such as immune modulators and proteasome inhibitors, moving away from older chemotherapeutic agents.

Current and emerging immunotherapy strategies, including monoclonal antibodies, checkpoint inhibitors, vaccines, and adoptive T-cell therapies, are being integrated into standard treatment, indicating a promising future for managing this disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The immunotherapy era of myeloma: monoclonal antibodies, vaccines, and adoptive T-cell therapies. Hoyos, V., Borrello, I.[2022]

Elotuzumab, when combined with lenalidomide and dexamethasone, significantly improves progression-free survival (PFS) in patients with relapsed or refractory multiple myeloma, with a median PFS of 19.4 months compared to 14.9 months for the standard treatment.

The treatment showed a higher overall response rate (ORR) of 75.8% versus 65.5% for the standard therapy, although serious adverse reactions were more common in the elotuzumab group (65% vs. 57%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Drug Approval: Elotuzumab in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma. Gormley, NJ., Ko, CW., Deisseroth, A., et al.[2018]

The selective JAK1 inhibitor INCB052793 (INCB) significantly reduced the viability of multiple myeloma (MM) cells in both patient samples and cell lines, indicating its potential as an effective treatment.

In vivo studies in mice showed that INCB not only decreased tumor growth when used alone but also enhanced the anti-tumor effects when combined with other treatments like proteasome inhibitors and glucocorticosteroids, suggesting a promising strategy for MM therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anti-myeloma effects of the selective JAK1 inhibitor (INCB052793) alone and in combination in vitro and in vivo. Sanchez, E., Li, M., Patil, S., et al.[2019]

The p38 MAPK inhibitor VX-745 effectively reduces the secretion of interleukin 6 (IL-6) and vascular endothelial growth factor (VEGF) from bone marrow stromal cells without harming their viability, indicating a potential therapeutic role in multiple myeloma.

VX-745 not only inhibits the proliferation of multiple myeloma cells but also counters drug resistance linked to cell adhesion in the bone marrow environment, highlighting p38 MAPK as a promising target for improving treatment outcomes in patients with multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting p38 MAPK inhibits multiple myeloma cell growth in the bone marrow milieu. Hideshima, T., Akiyama, M., Hayashi, T., et al.[2021]

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]

A systematic review and network meta-analysis of 37 randomized trials involving patients with relapsed and/or refractory multiple myeloma (MM) found that the combination of daratumumab, lenalidomide, and dexamethasone significantly improved progression-free survival compared to dexamethasone alone, with a hazard ratio of 0.13.

The study confirms the strong efficacy of three-drug regimens that include anti-CD38 antibodies, providing valuable insights for evaluating new treatments like chimeric antigen receptor T-cell therapies and bispecific T-cell engagers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relapsed and refractory multiple myeloma: A systematic review and network meta-analysis of the efficacy of novel therapies. Minakata, D., Fujiwara, SI., Yokoyama, D., et al.[2023]

From 2011 to 2019, treatment for multiple myeloma has shifted towards more combination therapies, with triplet regimens (PI-IMiD-dexamethasone) becoming the most common first-line treatment by 2018-2019, indicating a trend towards more aggressive treatment strategies.

Despite advancements in treatment, median overall survival decreased with each subsequent line of therapy, highlighting the challenges in managing multiple myeloma as the disease progresses, although survival rates improved for patients diagnosed more recently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in the multiple myeloma treatment landscape and survival: a U.S. analysis using 2011-2019 oncology clinic electronic health record data. Braunlin, M., Belani, R., Buchanan, J., et al.[2021]

In a study involving 121 patients with newly diagnosed multiple myeloma, maintenance therapy with the oral proteasome inhibitor ixazomib after induction therapy led to a significant increase in response rates, with 35% achieving a complete response after maintenance.

The safety profile of ixazomib was favorable, with only 24% of patients experiencing grade 3 or higher drug-related adverse events, indicating that ixazomib can be safely administered for long-term treatment without cumulative toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ixazomib maintenance therapy in newly diagnosed multiple myeloma: An integrated analysis of four phase I/II studies. Dimopoulos, MA., Laubach, JP., Echeveste Gutierrez, MA., et al.[2019]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06604715

NCT06604715 | A Study of JNJ-87562761 in Participants ... The purpose of this study is to determine the recommended phase 2 dose(s) (RP2D[s]) of JNJ-87562761 in Part 1 (dose escalation), and to determine the safety ...

2. jnj.com jnj.com/media-center/press-releases/johnson-johnson-reinforces-its-leadership-in-hematology-at-ash-2025-unveiling-new-paradigm-shifting-research

Johnson & Johnson reinforces its leadership in hematology ... Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.

3. withpower.com withpower.com/trial/phase-1-multiple-myeloma-11-2024-09b66

JNJ-87562761 for Multiple Myeloma In a study of multiple myeloma (MM) patients, 57% showed overexpression of JAK2 and 27% showed overexpression of JAK1, suggesting that targeting these JAK ...

4. clin.larvol.com clin.larvol.com/trial-detail/NCT06604715

A Study of JNJ-87562761 in Participants With Relapsed or ... A Study of JNJ-87562761 in Participants With Relapsed or Refractory Multiple Myeloma. DLTs are specific adverse events and are defined as any of the following: ...

5. jnj.com jnj.com/innovativemedicine/download/ASH_2025_Abstract_Table.pdf

Multiple Myeloma CARVYKTI® (ciltacabtagene autoleucel) ... Updated efficacy and safety results of JNJ-5322, a novel, next- generation, BCMA×GPRC5D×CD3 trispecific antibody, in patients with relapsed ...

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06604715/

Trial | NCT06604715 The purpose of this study is to determine the recommended phase 2 dose(s) (RP2D\[s\]) of JNJ-87562761 in Part 1 (dose escalation), and to determine the safety ...

7. clinicaltrials.jnj.com clinicaltrials.jnj.com/en/study-detail/NCT06604715

A Study of JNJ-87562761 in Participants With Relapsed or ... The purpose of this study is to determine the recommended phase 2 dose(s) (RP2D[s]) of JNJ-87562761 in Part 1 (dose escalation), and to determine the safety ...

8. firstwordpharma.com firstwordpharma.com/story/6516014

Johnson & Johnson reinforces its leadership in hematology ... Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.