What side effects are associated with this type of intervention?

Common treatments for blood cancers, such as monoclonal antibodies (e.g., Talquetamab), chemotherapy, and hematopoietic cell transplantation, have a range of side effects. Monoclonal antibodies can cause cytopenias, including neutropenia, anemia, and thrombocytopenia, as well as non-hematologic effects like nausea, anorexia, and asthenia. Chemotherapy often leads to gastrointestinal issues, hair loss, and increased susceptibility to infections. Hematopoietic cell transplantation, particularly with myeloablative conditioning, is associated with significant toxicity across multiple systems, including hematologic, gastrointestinal, hepatic, and pulmonary, with high rates of treatment-related mortality.

What prior FDA approvals exist?

The FDA has approved several treatments for blood cancers, including multiple myeloma. Notable approvals include daratumumab, a monoclonal antibody targeting CD38, used in combination with bortezomib, melphalan, and prednisone for newly diagnosed multiple myeloma. Another significant approval is for lenalidomide in combination with dexamethasone for initial therapy of multiple myeloma. Additionally, CAR-T cell therapies like brexucabtagene autoleucel have been approved for relapsed or refractory mantle cell lymphoma. These treatments, like Talquetamab, focus on targeted mechanisms to improve patient outcomes in blood cancers.

What other types of research exist?

Promising novel alternatives to Talquetamab for blood cancer patients include: <ol> <li>Zanubrutinib plus Rituximab for mantle cell lymphoma, which has shown favorable pharmacokinetic/pharmacodynamic properties and minimal off-target effects.</li> <li></li> </ol> Daratumumab in combination with Bortezomib and Dexamethasone for multiple myeloma, which has demonstrated improved overall survival and progression-free survival. 3. Acalabrutinib, either as monotherapy or in combination with Obinutuzumab, for chronic lymphocytic leukemia, which has shown significant clinical activity and a favorable safety profile.

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Monoclonal Antibodies

Talquetamab for Multiple Myeloma (MonumenTAL-1 Trial)

Phase 1

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria

Must not have

Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)

Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2.10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Talquetamab, a new drug, in adults with multiple myeloma that has come back or didn't respond to other treatments. Doctors will monitor patients' health to see if the drug works and is safe.

Who is the study for?

This trial is for adults with multiple myeloma that's gotten worse after standard treatments or who couldn't handle those treatments. They must understand the study and agree to participate, have a good performance status (able to carry out daily activities), and meet specific disease measurement criteria. Women able to have children need a negative pregnancy test.

What is being tested?

The trial is testing Talquetamab, aiming to find the safest dose for Phase 2 trials. It has two parts: first, increasing doses to find what's safe (Dose Escalation), then giving this safe dose to more people (Dose Expansion) to confirm its safety.

What are the potential side effects?

Specific side effects of Talquetamab aren't listed here, but generally in such trials patients may experience immune reactions, fatigue, nausea, or other drug-related issues which will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My multiple myeloma diagnosis follows international guidelines.

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My multiple myeloma is measurable and I've tried all treatments without success or couldn't tolerate them.

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My multiple myeloma has worsened despite treatment, or I couldn't tolerate the treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have taken a lot of steroids, like prednisone, recently.

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Side effects from my past cancer treatments have mostly gone away.

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My multiple myeloma has affected or is suspected to affect my brain or spinal cord.

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I had a stem cell transplant recently and am not on immunosuppressants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2.10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2.10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2.10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Part 1: Dose-limiting Toxicity (DLT)

Secondary study objectives

Part 1 and Part 2: Biomarker Assessment

Part 1: Number of Participants with Talquetamab Antibodies

Part 1: Talquetamab Serum Concentrations

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 2: Dose Expansion (Talquetamab)Experimental Treatment1 Intervention

Participants will receive IV infusion or SC injection of Talquetamab at each putative recommended Phase 2 dose(s) (RP2D\[s\]) as determined in Part 1. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment.

Group II: Part 1: Dose Escalation (Talquetamab) - Subcutaneous (SC)Experimental Treatment1 Intervention

Participants will receive Talquetamab SC. The dose levels will be selected to identify safe and tolerable putative RP2D(s). All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment.

Group III: Part 1: Dose Escalation (Talquetamab) - Intravenous (IV)Experimental Treatment1 Intervention

Participants will receive IV infusion of Talquetamab at minimum anticipated biologic effect level (MABEL)-based starting dose until the completion of the end of treatment visit. Subsequent dose levels will be selected based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and preliminary antitumor activity data. All participants (ongoing and those who are in follow-up) will transition to open-label extension (OLE) phase and will continue to receive the study treatment.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for blood cancers include targeted therapies, immunotherapies, and chemotherapies. Targeted therapies, such as tyrosine kinase inhibitors, work by specifically targeting and inhibiting cancer cell growth pathways, which can lead to cancer cell death while sparing normal cells. Immunotherapies, like monoclonal antibodies and CAR-T cell therapy, enhance the body's immune system to recognize and destroy cancer cells. Chemotherapies use cytotoxic drugs to kill rapidly dividing cells, including cancer cells. These treatments are crucial for blood cancer patients as they offer different mechanisms to attack cancer cells, potentially leading to better outcomes and fewer side effects. Talquetamab, for example, is an investigational immunotherapy that targets specific antigens on multiple myeloma cells, aiming to improve treatment efficacy and safety.

Development of the PARP inhibitor talazoparib for the treatment of advanced BRCA1 and BRCA2 mutated breast cancer.Population-based meta-analysis of bortezomib exposure-response relationships in multiple myeloma patients.A phase II multicenter study of troxacitabine in relapsed or refractory lymphoproliferative neoplasms or multiple myeloma.