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NCT01531998 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide/Bortezomib/Dexamethasone & CNTO 328 in Transplant Eligible Newly Diagnosed Multiple Myeloma (MM)
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01531998: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01531998 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01531998, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of Siltuximab that can be given in combination with Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone to patients with MM. The safety of this drug combination will also be studied.
Primary Outcome
Maximum tolerated dose (MTD) defined as follows: At first dose level, if greater than 1 out of 3 patients or greater than 1 out of 6 patients experience dose limiting toxicity (DLT), the dose level exceeds the maximum tolerated dose (MTD). Dose limiting toxicity (DLT) defined as toxicities graded in severity according to the guidelines outlined in the NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- BEHAVIORAL Questionnaires
- DRUG Siltuximab
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT01531998 record still lists
NCT01531998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.
NCT01531998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01531998 about?
NCT01531998 is a clinical study titled "Lenalidomide/Bortezomib/Dexamethasone & CNTO 328 in Transplant Eligible Newly Diagnosed Multiple Myeloma (MM)". The goal of this clinical research study is to find the highest tolerable dose of Siltuximab that can be given in combination with Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone to patients with MM. The safety of this drug combination will also be studied.
What is the current status of trial NCT01531998?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2012-05. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01531998?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Questionnaires (BEHAVIORAL), Siltuximab (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT01531998?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01531998's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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