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NCT01985126 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
NCT01985126 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 124 participants.
The verdict
NCT01985126, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor \[PI\] and immunomodulatory drug \[IMiD\]) or are double refractory to a PI and an IMiD.
Interventions
- DRUG Acetaminophen
- DRUG Methylprednisolone
- DRUG Diphenhydramine
- DRUG Daratumumab 16 mg/kg (Part 1)
- DRUG Daratumumab 8 mg/kg (Part 1)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2013-09-27 |
| Est. Completion | 2017-05-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01985126
The ClinicalTrials.gov registry entry for NCT01985126 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.
NCT01985126 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01985126 about?
NCT01985126 is a clinical study titled "An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD". The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor \[PI\] and immunomodulatory drug \[IMiD\]) or are double refractory to a PI...
What is the current status of trial NCT01985126?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2013-09-27. Estimated completion is 2017-05-30.
What interventions are being tested in trial NCT01985126?
The interventions under investigation include: Acetaminophen (DRUG), Methylprednisolone (DRUG), Diphenhydramine (DRUG), Daratumumab 16 mg/kg (Part 1) (DRUG), Daratumumab 8 mg/kg (Part 1) (DRUG).
Who is sponsoring clinical trial NCT01985126?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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