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NCT06577025 · ClinicalTrials.gov registry record · Phase 2
A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma
A Phase 2 study of Multiple Myeloma, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 16
- Study locations
NCT06577025: Active Phase 2 study of Multiple Myeloma, sponsored by Janssen Research & Development.
NCT06577025 is a Phase 2 study of Multiple Myeloma that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 43 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (92% lower). The trial reports 16 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06577025, a Phase 2 study of Multiple Myeloma, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 16
- Study locations
Study Summary
The purpose of this study is to evaluate the rate of response (how effectively treatment is working) with signs of potential cure at 5 years after the start of induction treatment. This is defined as a composite of sustained (at least 2 years) minimal residual disease (MRD) negativity with complete response/stringent complete response (CR/sCR) and a positron emission tomography/computed tomography (PET/CT) scan that does not show any signs of cancer at 5 years. MRD negativity and CR/sCR is defined as no detectable signs of remaining cancer cells after the treatment. This study will also characterize how well the treatments administered work in the study through progression-free survival (PFS). PFS is defined as the length of time during and after the treatment of a disease, that a participant lives with the disease, but it does not get worse.
Primary Outcome
Rate of Response with curative potential is defined as the percentage of participants with a composite of durable (at least 2 years) minimal residual disease (MRD) (10\^-5) negativity with complete response/stringent complete response (CR/sCR) by serology and negative positron emission tomography/computed tomography (PET/CT) imaging at 5-years after start of induction therapy. This includes: negative imaging at 5-year landmark time; MRD-negative status (at 10\^-5) in 2 bone marrow examinations t
Conditions Studied
Interventions
- DRUG Teclistamab
- DRUG Daratumumab
- DRUG Cilta-cel
- DRUG Talquetamab
- DRUG Bortezomib
Study Locations (16)
Other
- Peter MacCallum Cancer Centre - Melbourne
- The Alfred Hospital - Melbourne
- Instituto D Or de Pesquisa e Ensino - Salvador
- Fundacao Antonio Prudente A C Camargo Cancer Center - São Paulo
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein - São Paulo
- Universitaetsklinikum Heidelberg - Heidelberg
- Universitaetsklinikum Tuebingen - Tübingen
- Universitatsklinikum Wurzburg - Würzburg
- Hosp. Univ. 12 de Octubre - Madrid
- Hosp Clinico Univ de Salamanca - Salamanca
- Hosp. Univ. Marques de Valdecilla - Santander
California
- City of Hope - Duarte
- University of California San Francisco - San Francisco
Iowa
- University of Iowa Hospital and Clinics - Iowa City
New York
- Memorial Sloan Kettering Cancer Center - New York
North Carolina
- Levine Cancer Institute - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2024-08-20 |
| Est. Completion | 2030-09-02 |
| Phase | Phase 2 |
What the registry record for NCT06577025 still lists
NCT06577025 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Teclistamab is the first listed.
NCT06577025 lists 16 locations in 5 states (Other, California, Iowa).
Frequently Asked Questions
What is clinical trial NCT06577025 about?
NCT06577025 is a clinical study titled "A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma". The purpose of this study is to evaluate the rate of response (how effectively treatment is working) with signs of potential cure at 5 years after the start of induction treatment. This is defined as a composite of sustained (at least 2 years) minimal residual disease (MRD) negativity with complete ...
What is the current status of trial NCT06577025?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2024-08-20. Estimated completion is 2030-09-02.
What conditions does trial NCT06577025 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT06577025?
The interventions under investigation include: Teclistamab (DRUG), Daratumumab (DRUG), Cilta-cel (DRUG), Talquetamab (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT06577025?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06577025 being conducted?
This trial has 16 study locations across California, Iowa, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06577025's enrollment target sits among peer trials
43 280th of 438 higher than 158 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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