What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma include proteasome inhibitors (e.g., bortezomib), immunomodulatory drugs (e.g., lenalidomide), and monoclonal antibodies (e.g., daratumumab). Known side effects of these treatments can include peripheral neuropathy, gastrointestinal issues, fatigue, infections, and hematologic toxicities such as neutropenia and thrombocytopenia. For treatments similar to Teclistamab, which is a bispecific antibody, side effects may include cytokine release syndrome, infections, and cytopenias. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma that target BCMA, similar to Teclistamab. These include the anti-BCMA antibody-drug conjugate belantamab mafodotin and BCMA-directed chimeric antigen receptor (CAR) T cell therapies such as idecabtagene vicleucel and ciltacabtagene autoleucel. Additionally, bispecific T cell engagers (BiTEs) like teclistamab, which target BCMA and CD3 to redirect T-cells to kill myeloma cells, are being actively studied. These therapies represent a significant advancement in the treatment of relapsed or refractory Multiple Myeloma by leveraging the immune system to target cancer cells.

What other types of research exist?

Promising novel alternatives to Teclistamab for Multiple Myeloma patients include: <ol> <li>Daratumumab: An anti-CD38 monoclonal antibody that has shown higher rates of infection but is effective in treating relapsed/refractory and newly diagnosed patients.</li> <li></li> </ol> Elotuzumab: Another monoclonal antibody that targets SLAMF7, used in combination with lenalidomide and dexamethasone, showing similar infection rates but higher lymphocytopenia and herpes zoster episodes. 3. Isatuximab: An anti-CD38 monoclonal antibody approved for relapsed/refractory MM, often combined with pomalidomide and dexamethasone. 4. Venetoclax: A BCL-2 inhibitor, particularly effective in patients with t(11;14) translocation. 5. CAR T-cell therapies: Such as idecabtagene vicleucel and ciltacabtagene autoleucel, which have shown promising results in heavily pretreated patients.

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Monoclonal Antibodies

Teclistamab for Multiple Myeloma

Phase 2

Recruiting

Research Sponsored by SCRI Development Innovations, LLC

Eligibility Criteria Checklist

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

Must have

Has documented diagnosis of MM according to the IMWG diagnostic criteria (Rajkumar 2011)

Has an ECOG performance status (Oken 1982) of 0 to 1

Must not have

Has fever or active infection (bacterial, viral, or uncontrolled systemic fungal) at time of study enrollment

Has clinically significant coagulopathy that would increase the risk of bleeding in the setting of cytopenia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months of teclistamab or 6 months for talquetamab treatment

Awards & highlights

Summary

This trial is testing Teclistamab, a drug that helps the immune system fight a type of blood cancer in adults who haven't responded to other treatments. It works by connecting immune cells to cancer cells, making it easier for the body to attack the cancer. Teclistamab shows promise in multiple myeloma treatment.

Who is the study for?

Adults over 18 with Multiple Myeloma who've had at least four prior treatments, including specific therapies (PI, IMiD, CD38 antibody), can join. They must be in good health otherwise, not pregnant or planning to become so, and agree to use contraception. Participants need a body weight over 35 kg and must stay close to the trial site for monitoring after initial doses.

What is being tested?

The study is testing Teclistamab given as an outpatient treatment for Multiple Myeloma patients. It's a phase II trial which means they're looking at how effective this drug is and what side effects it has when administered outside of a hospital setting.

What are the potential side effects?

Possible side effects include reactions related to the immune system like inflammation in different parts of the body (CRS), changes in mental status (ICANS), infections, bleeding due to coagulopathy issues, heart problems such as arrhythmias or heart failure, and lung issues like reduced airflow.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with multiple myeloma.

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

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I am informed about the side effects of teclistamab and have someone to watch over me.

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I have had 4 or more treatments for my multiple myeloma, including specific types of therapy.

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My body weight is over 35 kg.

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I am 18 years old or older.

Exclusion Criteria

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

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I do not have a fever or any active infections.

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I have a bleeding disorder that gets worse when my blood cell counts are low.

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I have severe blood-related or other serious health issues.

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I have experienced worsening in my mental state, like confusion or feeling more sleepy.

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My kidney function is very low or I am on dialysis.

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I cannot use tocilizumab or IVIG due to health reasons.

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My cancer has spread to my brain or spinal cord.

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I have serious heart conditions, including recent heart failure or heart attack.

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I have a specific blood disorder such as plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloidosis.

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I am at risk for TLS and need treatment to manage it.

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My cancer involves a high number of cancer cells in my bone marrow or has spread to multiple areas outside the bone marrow.

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I have not had a stroke or seizure in the last 6 months.

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I have not had any live vaccines in the last month and do not plan to during the study.

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I have received a blood or platelet transfusion in the last week.

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My lung function is less than half of what is expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months of teclistamab or 6 months for talquetamab treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months of teclistamab or 6 months for talquetamab treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months of teclistamab or 6 months for talquetamab treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of CRS of any grade during the first two cycles

Secondary study objectives

Duration of response (DOR)

Healthcare resource utilization in the outpatient setting

Incidence of All grade and Grade ≥3 ICANS

+23 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: TeclistamabExperimental Treatment2 Interventions

Participants will receive step up dosing of Teclistamab following the recommended dosage of TECVAYLI™ USPI followed by weekly dosing for twelve 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 2 weeks for participants who achieve partial response (PR) or better after 6 months of therapy.

Group II: TalquetamabExperimental Treatment2 Interventions

Participants will receive step up dosing of Talquetamab following the recommended dosage of TALVEY™ USPI followed by every 2 week dosing for six 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 6). Talquetamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better after Cycle 4

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

0 / 21Eligibility 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

Multiple Myeloma treatments often involve bispecific antibodies like Teclistamab, which target BCMA and CD3 to redirect T-cells to kill myeloma cells. This approach leverages the body's immune system to specifically target and destroy cancer cells. Proteasome inhibitors, such as bortezomib, disrupt protein degradation in myeloma cells, leading to cell death. Immunomodulatory drugs like lenalidomide enhance the immune response against myeloma cells and inhibit their growth. Monoclonal antibodies, such as daratumumab, target specific proteins on myeloma cells to mark them for destruction by the immune system. These treatments are crucial as they offer targeted, effective strategies to manage and potentially eradicate Multiple Myeloma, improving patient outcomes and survival rates.

Bispecific antibodies in acute lymphoblastic leukemia therapy.Multiple Myeloma: Current Advances and Future Directions.

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Who is running the clinical trial?

Janssen Research & Development, LLCIndustry Sponsor

987 Previous Clinical Trials

6,385,584 Total Patients Enrolled

75 Trials studying Multiple Myeloma

19,741 Patients Enrolled for Multiple Myeloma

SCRI Development Innovations, LLCLead Sponsor

191 Previous Clinical Trials

13,479 Total Patients Enrolled

9 Trials studying Multiple Myeloma

321 Patients Enrolled for Multiple Myeloma

Robert Rifkin, MDStudy ChairSCRI Development Innovations, LLC

~16 spots leftby Jan 2025

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