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NCT01217957 · ClinicalTrials.gov registry record · Phase 1
A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT01217957: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT01217957 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01217957, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
The purpose of Phase 1 of this study was to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral ixazomib administered in combination with lenalidomide and low-dose dexamethasone in participants with newly diagnosed multiple myeloma (NDMM). The purpose of Phase 2 of this study was to determine the overall response rate (ORR) and further evaluate the tolerability and toxicity of the combination of oral ixazomib, lenalidomide, and low-dose dexamethasone in patients with NDMM.
Primary Outcome
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Ixazomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2010-11-22 |
| Est. Completion | 2018-02-02 |
| Phase | Phase 1 |
What the finished NCT01217957 record still lists
NCT01217957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT01217957 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01217957 about?
NCT01217957 is a clinical study titled "A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma". The purpose of Phase 1 of this study was to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral ixazomib administered in combination with lenalidomide and low-dose dexamethasone in participants with newly diagnosed multiple myeloma (NDMM). Th...
What is the current status of trial NCT01217957?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2010-11-22. Estimated completion is 2018-02-02.
What interventions are being tested in trial NCT01217957?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Ixazomib (DRUG).
Who is sponsoring clinical trial NCT01217957?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01217957's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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