Preventive Treatments for Talquetamab-Related Oral Toxicity in Multiple Myeloma
(Talisman Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Janssen Research & Development, LLC
Disqualifiers: Stroke, Seizure, Heart failure, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to identify preventive treatments that can minimize the occurrence, severity, and duration of talquetamab-related taste changes (dysgeusia), during the prophylaxis (preventive) treatment phase, and to better characterize the signs or symptoms of talquetamab-related taste changes.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you should discuss your current medications with the trial team to ensure they don't interfere with the study.
What data supports the idea that Preventive Treatments for Talquetamab-Related Oral Toxicity in Multiple Myeloma is an effective drug?
The available research shows that nearly three quarters of the 288 patients with relapsed or refractory multiple myeloma in the MonumenTAL-1 trial experienced significant anticancer effects from talquetamab. This suggests that talquetamab is effective in treating this condition. Additionally, talquetamab has been granted accelerated approval in the USA and conditional marketing authorization in the EU for treating adults with relapsed or refractory multiple myeloma, indicating its recognized effectiveness. Compared to another treatment, belantamab mafodotin, which had a response rate of 31% and a median progression-free survival of 2.9 months, talquetamab shows a higher rate of significant anticancer effects.
12345What safety data is available for Talquetamab in treating multiple myeloma?
Talquetamab, also known as Talvey, has been evaluated for safety in multiple studies. It was granted accelerated approval in the USA and conditional marketing authorization in the EU for relapsed or refractory multiple myeloma. In clinical trials, Talquetamab showed significant anticancer effects but also presented unique side effects, including dysgeusia (taste changes) in 60% of patients and xerostomia (dry mouth) in 30-57% of patients. It has fewer infections compared to teclistamab but includes skin, oral, and nail-related adverse events. Despite these side effects, it is considered a well-tolerated and effective treatment option for heavily pretreated multiple myeloma.
12346Is the drug Talquetamab a promising treatment for multiple myeloma?
Yes, Talquetamab is a promising drug for multiple myeloma. It has shown significant anticancer effects in nearly three-quarters of patients in trials and has been approved for use in the USA and EU for patients with relapsed or refractory multiple myeloma.
12345Eligibility Criteria
This trial is for individuals with multiple myeloma who have seen their disease progress after treatment. They should be relatively active (able to care for themselves or up and about more than half of the day) and able to follow certain lifestyle restrictions. Those who've had prior treatments with proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies can join.Inclusion Criteria
My cancer has worsened after my last treatment, as confirmed by my doctor.
I have been diagnosed with multiple myeloma.
I have been treated with proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Prophylaxis Treatment
Participants receive prophylactic interventions to minimize talquetamab-related oral toxicity, starting 7 days before talquetamab treatment
Up to 12 months
Talquetamab Treatment
Participants are treated with talquetamab subcutaneously until disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study
Up to 30 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study aims to find out which preventive treatments are best at reducing taste distortion caused by talquetamab in patients with multiple myeloma. Participants will receive one of three prophylactic treatments alongside talquetamab to see which is most effective.
4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort D: Prophylaxis C and TalquetamabExperimental Treatment2 Interventions
Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive prophylaxis C along with talquetamab therapy. Participants will start the assigned prophylaxis 7 days before starting talquetamab treatment. After step-up dosing of talquetamab therapy, participants will be treated with talquetamab with prophylaxes for up to 12 months during prophylaxis treatment phase (if there are clinical benefits prophylaxis treatment can continue beyond 12 months, at the treating physician's discretion, after consultation with sponsor). The Talquetamab treatment phase will continue from C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first.
Group II: Cohort C: Prophylaxis B and TalquetamabExperimental Treatment2 Interventions
Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive prophylaxis B along with talquetamab therapy. Participants will start the assigned prophylaxis 7 days before starting talquetamab treatment. After step-up dosing of talquetamab therapy, participants will be treated with talquetamab with prophylaxes for up to 12 months during prophylaxis treatment phase (if there are clinical benefits prophylaxis treatment can continue beyond 12 months, at the treating physician's discretion, after consultation with sponsor). The Talquetamab treatment phase will continue from C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first.
Group III: Cohort B: Prophylaxis A and TalquetamabExperimental Treatment2 Interventions
Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive prophylaxis A along with talquetamab therapy. Participants will start the assigned prophylaxis 7 days before starting talquetamab treatment. After step-up dosing of talquetamab therapy, participants will be treated with talquetamab with prophylaxes for up to 12 months during prophylaxis treatment phase (if there are clinical benefits prophylaxis treatment can continue beyond 12 months, at the treating physician's discretion, after consultation with sponsor). The Talquetamab treatment phase will continue from Cycle 1 Day 1 (C1D1) until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first.
Group IV: Cohort A: TalquetamabActive Control1 Intervention
Participants with relapsed or refractory multiple myeloma (RRMM) who are triple-class exposed (previously exposed to at least 1 proteasome inhibitor \[PI\], 1 immunomodulatory drug(s) \[IMiD\]), and an anti-CD38 monoclonal antibody \[mAb\]) will be treated with talquetamab subcutaneously until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first.
Talquetamab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Talquetamab for:
- Relapsed or refractory multiple myeloma
🇪🇺 Approved in European Union as Talquetamab for:
- Relapsed or refractory multiple myeloma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Icahn School of Medicine at Mt. SinaiNew York, NY
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Who Is Running the Clinical Trial?
Janssen Research & Development, LLCLead Sponsor
References
Characterization of dysgeusia and xerostomia in patients with multiple myeloma treated with the T-cell redirecting GPRC5D bispecific antibody talquetamab. [2023]In recent years, various immunotherapies have improved the survival of patients with multiple myeloma (MM). However, there remains an unmet need for novel agents. Talquetamab is the first-in-class GPRC5D-targeting T-cell redirecting bispecific antibody, which has substantial activity in advanced MM. Rapidly after the start of talquetamab treatment, patients reported taste changes (dysgeusia; 60% of patients), and a feeling of dry mouth (xerostomia; 30-57% of patients), which may be related to expression of the target antigen in healthy tissues, such as taste buds. Here, we aimed at better characterizing these oral toxicities.
Talquetamab: First Approval. [2023]Talquetamab (talquetamab-tgvs; TALVEY®), a humanized, bispecific G-protein coupled receptor family C group 5 member D (GPRC5D)-directed CD3 T-cell engager, is being developed by Janssen for the treatment of multiple myeloma (MM). In early August 2023, talquetamab was granted accelerated approval in the USA for the treatment of adults with relapsed or refractory MM (RRMM) and in late August 2023, talquetamab was granted conditional marketing authorisation in the EU for the treatment of adult patients with RRMM. This article summarizes the milestones in the development of talquetamab leading to this first approval for RRMM.
Management of Ocular Toxicity in Patients Receiving Belantamab Mafodotin. [2023]While significant strides have been made in the treatment of multiple myeloma, treatment options remain limited and definite, and most patients ultimately succumb to their disease. The urgency for more treatment modalities remains, as patients who are refractory to proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies have a median survival of only 5.8 to 13 months. Belantamab mafodotin, a first-in-class antibody-drug conjugate, was approved by the US Food and Drug Administration in 2020 for patients with relapsed or refractory myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. It produced an overall response rate of 31%, and the median progression-free survival was 2.9 months when administered as a single agent. While generally well tolerated, ocular toxicities were a notable adverse event reported. In this article, we discuss the response data, toxicity profile including ocular toxicities, and treatment management.
MonumenTAL Results for Talquetamab in Myeloma. [2023]Nearly three quarters of the 288 patients with relapsed/refractory multiple myeloma enrolled in the phase I/II MonumenTAL-1 trial of the investigational drug talquetamab experienced significant anticancer effects. A first-in-class, off-the-shelf bispecific antibody, talquetamab targets GPRC5D, which is highly expressed on malignant plasma cells but limited on normal cells, and recruits CD3-expressing T cells, activating an immune response.
Treating Multiple Myeloma Patients With Oral Therapies. [2022]Recent advances have highlighted the importance of long-term, continuous treatment in multiple myeloma (MM) to improve survival. However, treatment burden continues to negatively impact the real-world duration of MM therapy, and strategies to limit the adverse impact of treatment on patient quality of life are therefore particularly important. Oral MM therapies include the immunomodulatory drugs lenalidomide, thalidomide, and pomalidomide; the alkylating agents melphalan and cyclophosphamide; the histone deacetylase inhibitor panobinostat; the corticosteroids prednisone and dexamethasone; and the proteasome inhibitor ixazomib. The most commonly reported adverse events with these treatments include hematologic events such as thrombocytopenia and neutropenia; the gastrointestinal events nausea, vomiting, and diarrhea; venous thrombotic events such as deep-vein thrombosis and pulmonary embolism; and events such as rash and peripheral neuropathy. It is important that patients receiving oral therapies at home report symptoms before they become difficult to manage. Appropriate management of these treatment-related adverse events, awareness of both food and drug interactions, and assisting patients with out-of-pocket costs are all important factors in providing efficacious, sustainable, and convenient MM therapy. We outline evidence-based recommendations to provide a practical guide for health care providers addressing the effective management of MM patients receiving oral therapy.
Talquetamab in multiple myeloma. [2023]Initial results of the Phase 1 trial of talquetamab, a bispecific antibody targeting GPRC5D and CD3, were reported in December of 2022 for the treatment of relapsed or refractory multiple myeloma in the fourth line or later setting. It demonstrated a similar efficacy profile and durability of response to teclistamab, the first bispecific antibody therapy to be approved in multiple myeloma. Additionally, it has less infections than teclistamab but demonstrates unique class specific side effects including skin, oral, and nail-related adverse events. Despite this, it is still a highly efficacious and well-tolerated therapy that will add to the armamentarium of therapeutics against heavily pretreated multiple myeloma.