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NCT06827860 · ClinicalTrials.gov registry record · Phase 2
Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse
A Phase 2 study of Multiple Myeloma in Relapse, sponsored by Larysa Sanchez.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT06827860 is a Phase 2 study of Multiple Myeloma in Relapse that is actively recruiting participants, run by Larysa Sanchez. The registered enrollment target is 23 participants, below the 50-participant average among 12 other Multiple Myeloma in Relapse trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06827860, a Phase 2 study of Multiple Myeloma in Relapse, is actively recruiting participants, sponsored by Larysa Sanchez.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
Induction therapy approaches in recent years have evolved, now utilizing triple or quadruple drug regimens in the majority of patients. By combining anti-CD38 antibodies, proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and steroids, patients achieve longer remissions with their first- and second-line therapies but also become refractory to most or all three major drug classes earlier. For patients who are refractory to at least 3 of the commonly administered PIs and IMiDs, occurring after 2 lines of therapy in many, the median overall survival is only 5 months. Elderly, frail patients are not often candidates at this point for aggressive therapies like stem cell transplantation and CAR T-cell therapy thus necessitating effective yet tolerable treatments for elderly patients in early relapse (1-3 prior therapy). Talquetamab is a GPRC5DxCD3 bispecific antibody that redirects patients' T cells to myeloma cells which express GPRC5D. In the phase 1 MonumenTAL-1, heavily pretreated patients with a median of 6 prior lines of therapy attained a 70% response rate with 405 μg/kg of subcutaneous (SC) talquetamab. Importantly, subcutaneous talquetamab was found to be tolerable for the treated population, which included 28% of patients aged ≥70, with only three patients experiencing dose-limiting toxicities in the form of grade 3 rashes which responded to steroids. The anti-CD38 antibody daratumumab eliminates CD38-positive T and B regulatory cells, potentiates the activity of bispecific antibodies like talquetamab, and may improve its efficacy when used in combination. The aim of this study will be to assess the efficacy and safety of treating elderly patients with relapsed/refractory multiple myeloma with at least ≥2 prior lines of therapy with subcutaneous talquetamab. Patients who have progressive disease on talquetamab or who fail to respond after 3 cycles will have subcutaneous daratumumab added to their regimen.
Conditions Studied
Interventions
- DRUG Daratumumab
- DRUG Talquetamab
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2025-11-18 |
| Est. Completion | 2028-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06827860
The ClinicalTrials.gov registry entry for NCT06827860 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 50-participant average among 12 other Multiple Myeloma in Relapse trials with a reported enrollment target (54% lower). The listed sponsor is Larysa Sanchez, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Myeloma in Relapse appearing as the primary indexed condition, and to 2 interventions - of which Daratumumab is the first listed.
NCT06827860 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06827860 about?
NCT06827860 is a clinical study titled "Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse". Induction therapy approaches in recent years have evolved, now utilizing triple or quadruple drug regimens in the majority of patients. By combining anti-CD38 antibodies, proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and steroids, patients achieve longer remissions with their first- a...
What is the current status of trial NCT06827860?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2025-11-18. Estimated completion is 2028-01.
What conditions does trial NCT06827860 study?
This clinical trial studies the following conditions: Multiple Myeloma in Relapse.
What interventions are being tested in trial NCT06827860?
The interventions under investigation include: Daratumumab (DRUG), Talquetamab (DRUG).
Who is sponsoring clinical trial NCT06827860?
This trial is sponsored by Larysa Sanchez, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06827860 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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