Talquetamab for Multiple Myeloma
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Must not be taking: Anticoagulants, Corticosteroids, Monoclonal antibodies, others
Disqualifiers: CNS pathology, Autoimmune disease, Hepatitis, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
The researchers are doing this study to find out whether talquetamab is an effective treatment after BCMA CAR Tcell therapy for people with relapsed or refractory multiple myeloma. All participants in this study will have already received the BCMA CAR T-cell therapy ide-cel for their disease.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, it does mention that certain treatments, like monoclonal antibody therapy and cytotoxic therapy, should not have been received within a specific time frame before enrollment. It's best to discuss your current medications with the trial team to get a clear answer.
What data supports the effectiveness of the drug Talquetamab for treating multiple myeloma?
Is Talquetamab safe for humans?
How is the drug talquetamab different from other treatments for multiple myeloma?
Talquetamab is unique because it is a first-in-class bispecific antibody that targets a specific protein (GPRC5D) found on cancerous plasma cells and recruits T cells to attack them. This approach is different from other treatments that target more common proteins like CD38, and it has shown significant anticancer effects in patients with relapsed or refractory multiple myeloma.12356
Eligibility Criteria
This trial is for adults with multiple myeloma who've had BCMA CAR T-cell therapy. They must be in good health, not planning to have children soon, and able to follow the study plan. People can't join if they've had certain other treatments recently, are pregnant or breastfeeding, have serious infections or illnesses that could affect participation, or require high doses of steroids.Inclusion Criteria
Your blood and urine tests show very low levels of certain proteins.
My liver tests are within the required limits.
Must sign an ICF (or their legally acceptable representative must sign) indicating understanding and willingness to participate in the study
See 15 more
Exclusion Criteria
You have certain medical conditions or diseases at the same time.
I have a significant brain or nerve condition.
You have tested positive for certain infectious diseases.
See 15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive subcutaneous Talquetamab after BCMA CAR T-cell therapy
up to 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Talquetamab (CAR T-cell Therapy)
Trial OverviewThe study tests Talquetamab's effectiveness in patients with relapsed/refractory multiple myeloma post-BCMA CAR T-cell therapy ide-cel. It aims to determine if this drug can help after previous treatment with a specific cell therapy.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: TalquetamabExperimental Treatment1 Intervention
Subcutaneous Talquetamab
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, NY
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, NJ
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, NJ
Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, NJ
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
Janssen PharmaceuticalsIndustry Sponsor
References
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.
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.
Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myeloma. [2023]Label="WHAT IS THIS SUMMARY ABOUT?" NlmCategory="UNASSIGNED">This plain language summary describes the results of a phase 1 research study (or clinical trial) called MonumenTAL-1 published in the New England Journal of Medicine in December 2022. A phase 1 study is an early clinical trial where researchers evaluate how safe a medicine is at different doses in a small number of people. In the MonumenTAL-1 study, researchers looked at a new medicine under development called talquetamab, for people living with multiple myeloma (a type of blood cancer) who did not respond (refractory), stopped responding (relapsed), or who had difficulty dealing with their previous treatments.
An Embarrassment of Riches: Three FDA-Approved Bispecific Antibodies for Relapsed Refractory Multiple Myeloma. [2023]In the past year, three new bispecific antibodies have received accelerated FDA approval for the treatment of relapsed/refractory multiple myeloma. In this article, we review the available data for these three agents, teclistamab, elranatamab, and talquetamab, and discuss practical considerations for their use in clinical settings while the medical community awaits randomized phase III clinical trial datasets comparing them to standard-of-care regimens.
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.
[Therapeutic monoclonal antibodies against multiple myeloma]. [2019]Multiple myeloma (MM) remains mostly incurable despite the recent progress in the treatment strategy. One of novel fields for anti-MM therapeutic strategy is the development of immunotherapy using monoclonal antibodies (MoAbs) against myeloma-specific antigens. This article focuses on the basic and clinical aspects of several emerging and promising novel MoAbs for MM, such as elotuzumab which targets CS1 and daratumumab which targets CD38. Both antigens are highly expressed in more than 90% of MM patients, and the clinical trials have shown promising anti-MM effects, especially in combination with immunomodulatory agent lenalidomide. We also discuss the characteristics and the results of clinical trials of other MoAbs, such as tabalumab against B cell activating factor or dacetuzumab against CD40, being developed for MM.