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NCT03399799 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1 study of Hematological Malignancies, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 1
- Development phase
- 279
- Enrollment target
- 13
- Study locations
NCT03399799: Active Phase 1 study of Hematological Malignancies, sponsored by Janssen Research & Development.
NCT03399799 is a Phase 1 study of Hematological Malignancies that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 279 participants, below the 759-participant average among 16 other Hematological Malignancies trials with a reported enrollment target (63% lower). The trial reports 13 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03399799, a Phase 1 study of Hematological Malignancies, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 279 participants
- Enrollment target
- 13
- Study locations
Study Summary
The purpose of this study is to characterize the safety of Talquetamab and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for Talquetamab (Part 1 \[Dose Escalation\]) and to further characterize the safety of Talquetamab at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 \[Dose Expansion\]).
Primary Outcome
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non-hematological toxicity of Grade 3 or higher.
Conditions Studied
Interventions
- DRUG Talquetamab
Study Locations (13)
Other
- Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman - Liège
- VU Medisch Centrum - Amsterdam
- UMCU - Utrecht
- Hosp. Univ. Germans Trias I Pujol - Badalona
- Hosp Univ Fund Jimenez Diaz - Madrid
- Clinica Univ. de Navarra - Pamplona
- Hosp. Quiron Madrid Pozuelo - Pozuelo de Alarcón
- Hosp Clinico Univ de Salamanca - Salamanca
Alabama
- University of Alabama Birmingham - Birmingham
California
- City of Hope - Duarte
Colorado
- University of Colorado Cancer Center - Aurora
New York
- Mount Sinai Medical Center - New York
Tennessee
- Tennessee Oncology - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2017-12-16 |
| Est. Completion | 2027-10-20 |
| Phase | Phase 1 |
What the registry record for NCT03399799 still lists
NCT03399799 is an interventional study that assigns participants to a tested intervention. The registered 279 participants enrollment target is mid-sized for trials with a published cap, below the 759-participant average among 16 other Hematological Malignancies trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Hematological Malignancies appearing as the primary indexed condition, and to 1 intervention - of which Talquetamab is the first listed.
NCT03399799 lists 13 locations in 6 states (Other, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT03399799 about?
NCT03399799 is a clinical study titled "Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma". The purpose of this study is to characterize the safety of Talquetamab and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for Talquetamab (Part 1 \[Dose Escalation\]) and to further characterize the safety of Talquetamab at the recommended Phase 2 dose(s...
What is the current status of trial NCT03399799?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 279 participants. The study started on 2017-12-16. Estimated completion is 2027-10-20.
What conditions does trial NCT03399799 study?
This clinical trial studies the following conditions: Hematological Malignancies.
What interventions are being tested in trial NCT03399799?
The interventions under investigation include: Talquetamab (DRUG).
Who is sponsoring clinical trial NCT03399799?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03399799 being conducted?
This trial has 13 study locations across Alabama, California, Colorado, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03399799's enrollment target sits among peer trials
279 5th of 16 higher than 12 of 16 other Hematological Malignancies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematological Malignancies 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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